Prostate Cancer 101
Prostate cancer is defined as the growth of malignant cells within the prostate, part of the male productive system. The prostate is a walnut-sized gland located in front of the rectum and below the bladder. Prostate glands (also called the seminal vesicles) are part of the organ that produces most fluids in the semen. The size of the prostate gland enlarges as the male ages.
Although one of the most common types of cancer among male patients in the US, the development of prostate cancer is often slow (indolent). There is a high chance of successful treatment when detected in the early stages. A simple blood test focusing on the prostate-specific antigen (PSA) produced by the prostate can measure the level of protein in the blood and detect any abnormalities. Another method to detect prostate cancer is a digital rectal exam (DRE). The doctor examines the patient’s lower rectum, pelvis, and lower belly and physically searches for an abnormal mass.
There are five types of prostate cancer:
- Acinar adenocarcinoma: In general, adenocarcinoma is a type of cancer that starts in glandular (mucus-producing) cells. Acinar adenocarcinomas are the most common type, consisting of 95 percent of prostate cancer cases.
- Ductal adenocarcinoma: This starts in cells that line in the ducts (tubes) of the prostate gland and tends to grow and spread more quickly than acinar adenocarcinoma. It is a rare, aggressive, and histologic variant of prostate cancer.
- Transitional cell (or urothelial) cancer: It is the type that starts in the urethra, which is the tube carrying urine to the outside of the body. Transitional cell cancer usually starts in the bladder and then spreads into the prostate. In some cases, it first begins in the prostate and then spreads into the bladder entrance and the nearby tissues.
- Squamous cell cancer: This is a rare type of prostate cancer that starts in the flat cells covering the prostate.
- Small cell prostate cancer: Small cell prostate cancer comprises small round cells. It’s rare and a type of neuroendocrine cancer.
Symptoms and Signs
The symptoms and signs of prostate cancer can vary. Although the cause might be a condition other than cancer, any of the symptoms should be taken seriously, and the person experiencing one or more symptoms is advised to see a doctor right away. The general symptoms of prostate cancer are as listed:
- Difficulty starting urination.
- Weak or interrupted flow of urine.
- Frequent urination, especially at night.
- Difficulty emptying the bladder completely.
- Pain or burning during urination.
- Blood in the urine or semen.
- Pain in the back, hips, or pelvis that doesn’t go away.
- Painful ejaculation.
Risk Factors
A risk factor is defined as the cause that increases the chances of the occurrence of a disease. For example, the risk factors for prostate cancer differ in age, race/ethnicity, geography, family history (genetics), gene changes, lifestyle, and medical history.
Age: Prostate cancer is rare among men under 40. However, with age, the risk increases rapidly. According to data from Cancer.org, about 6 in 10 cases of prostate cancer are found in men older than 65.
Race/Ethnicity: Although racial and ethnic causes cannot be identified clearly, prostate cancer is most common among African American men. This group also tends to develop prostate cancer earlier than the rest of the population.
Geography: There is insufficient data to back the geographical factors wholly based on one’s region. They are generally associated with lifestyle choices such as diet and habits. But in general, prostate cancer is most common among men in North America, northwestern Europe, Australia, and on Caribbean Islands, while seen less commonly in Asia, Africa, Central America, and South America.
Family History: Although it does not necessarily mean a person will develop prostate cancer during their lifetime if they have a prostate cancer patient in their family, it still presents itself as a genetic risk factor. About 20 percent of all prostate cancer patients have a family member with the same disease. According to Cancer.org, having a father or brother with prostate cancer more than doubles a man’s risk of developing the disease. It is noted that the risk is even higher for men whose brother has prostate cancer than for those whose father has it. If more than one relative has prostate cancer, the risk is much higher, especially if it is detected in their youth. Scientists consider a patient in a high-risk group if the following situations exist:
- Three or more family members who have had prostate cancer
- At least two first-degree family members under the age of 55 with prostate cancer
- Prostate cancer on one side of the family in 3 generations
Inherited mutations occur in the following genes:
- BRCA1 and BRCA2
- CHEK2, ATM, PALB2, and RAD51D
- HOXB13
- DNA mismatch repair genes (MSH2, MSH6, MLH1, and PMS2)
- RNASEL (formerly called HPC1)
Lifestyle: A person’s habits, behavior and living conditions, and exposure to certain chemicals might affect prostate cancer development. The findings show that obese men have a lower risk of developing slow-growing prostate cancer a high risk of developing aggressive types of prostate cancer. In addition, men consuming dairy products have a slightly higher risk of getting prostate cancer.
Smoking is considered a factor that increases the mortality of the disease. There is some evidence that firefighters can be exposed to chemicals that may increase the risk of prostate cancer. And although considered as suggestive evidence by the National Academy of Medicine, exposure to Agent Orange (a chemical widely used during the Vietnam War) might be a possible risk factor. Having a vasectomy is also researched as a risk factor. Although some studies found that it might slightly increase the risk, others have not seen that.
Prevention
There is a link between the risk factors and prostate cancer prevention. Age, race, and genetics are considered factors that cannot be controlled; however, some lifestyle changes might be adapted to diminish the risk of developing the disease. Having regular exercise helps strengthen the cardiovascular system, which improves the body’s overall condition. Following a healthy diet that contains various nutritious sources, limiting red meat, avoiding processed and high-sugar food and beverages also contributes to overall health. Although not all researchers agree, reducing calcium intake is also considered a risk-lowering behavior. Several kinds of research show that some vitamins (Vitamin E and selenium), minerals, and supplements (soy and isoflavones) may reduce the risk of prostate cancer. But it should be noted that these should not be taken without consulting a doctor since they might have risks and benefits.
Sources:
Cancer.org
Cancerresearchuk.org
Prostate.org.au
Prostate Cancer 101
Prostate cancer is defined as the growth of malignant cells within the prostate, part of the male productive system. The prostate is a walnut-sized gland located in front of the rectum and below the bladder. Prostate glands (also called the seminal vesicles) are part of the organ that produces most fluids in the semen. The size of the prostate gland enlarges as the male ages.
Although one of the most common types of cancer among male patients in the US, the development of prostate cancer is often slow (indolent). There is a high chance of successful treatment when detected in the early stages. A simple blood test focusing on the prostate-specific antigen (PSA) produced by the prostate can measure the level of protein in the blood and detect any abnormalities. Another method to detect prostate cancer is a digital rectal exam (DRE). The doctor examines the patient’s lower rectum, pelvis, and lower belly and physically searches for an abnormal mass.
There are five types of prostate cancer:
- Acinar adenocarcinoma: In general, adenocarcinoma is a type of cancer that starts in glandular (mucus-producing) cells. Acinar adenocarcinomas are the most common type, consisting of 95 percent of prostate cancer cases.
- Ductal adenocarcinoma: This starts in cells that line in the ducts (tubes) of the prostate gland and tends to grow and spread more quickly than acinar adenocarcinoma. It is a rare, aggressive, and histologic variant of prostate cancer.
- Transitional cell (or urothelial) cancer: It is the type that starts in the urethra, which is the tube carrying urine to the outside of the body. Transitional cell cancer usually starts in the bladder and then spreads into the prostate. In some cases, it first begins in the prostate and then spreads into the bladder entrance and the nearby tissues.
- Squamous cell cancer: This is a rare type of prostate cancer that starts in the flat cells covering the prostate.
- Small cell prostate cancer: Small cell prostate cancer comprises small round cells. It’s rare and a type of neuroendocrine cancer.
Symptoms and Signs
The symptoms and signs of prostate cancer can vary. Although the cause might be a condition other than cancer, any of the symptoms should be taken seriously, and the person experiencing one or more symptoms is advised to see a doctor right away. The general symptoms of prostate cancer are as listed:
- Difficulty starting urination.
- Weak or interrupted flow of urine.
- Frequent urination, especially at night.
- Difficulty emptying the bladder completely.
- Pain or burning during urination.
- Blood in the urine or semen.
- Pain in the back, hips, or pelvis that doesn’t go away.
- Painful ejaculation.
Risk Factors
A risk factor is defined as the cause that increases the chances of the occurrence of a disease. For example, the risk factors for prostate cancer differ in age, race/ethnicity, geography, family history (genetics), gene changes, lifestyle, and medical history.
Age: Prostate cancer is rare among men under 40. However, with age, the risk increases rapidly. According to data from Cancer.org, about 6 in 10 cases of prostate cancer are found in men older than 65.
Race/Ethnicity: Although racial and ethnic causes cannot be identified clearly, prostate cancer is most common among African American men. This group also tends to develop prostate cancer earlier than the rest of the population.
Geography: There is insufficient data to back the geographical factors wholly based on one’s region. They are generally associated with lifestyle choices such as diet and habits. But in general, prostate cancer is most common among men in North America, northwestern Europe, Australia, and on Caribbean Islands, while seen less commonly in Asia, Africa, Central America, and South America.
Family History: Although it does not necessarily mean a person will develop prostate cancer during their lifetime if they have a prostate cancer patient in their family, it still presents itself as a genetic risk factor. About 20 percent of all prostate cancer patients have a family member with the same disease. According to Cancer.org, having a father or brother with prostate cancer more than doubles a man’s risk of developing the disease. It is noted that the risk is even higher for men whose brother has prostate cancer than for those whose father has it. If more than one relative has prostate cancer, the risk is much higher, especially if it is detected in their youth. Scientists consider a patient in a high-risk group if the following situations exist:
- Three or more family members who have had prostate cancer
- At least two first-degree family members under the age of 55 with prostate cancer
- Prostate cancer on one side of the family in 3 generations
Inherited mutations occur in the following genes:
- BRCA1 and BRCA2
- CHEK2, ATM, PALB2, and RAD51D
- HOXB13
- DNA mismatch repair genes (MSH2, MSH6, MLH1, and PMS2)
- RNASEL (formerly called HPC1)
Lifestyle: A person’s habits, behavior and living conditions, and exposure to certain chemicals might affect prostate cancer development. The findings show that obese men have a lower risk of developing slow-growing prostate cancer a high risk of developing aggressive types of prostate cancer. In addition, men consuming dairy products have a slightly higher risk of getting prostate cancer.
Smoking is considered a factor that increases the mortality of the disease. There is some evidence that firefighters can be exposed to chemicals that may increase the risk of prostate cancer. And although considered as suggestive evidence by the National Academy of Medicine, exposure to Agent Orange (a chemical widely used during the Vietnam War) might be a possible risk factor. Having a vasectomy is also researched as a risk factor. Although some studies found that it might slightly increase the risk, others have not seen that.
Prevention
There is a link between the risk factors and prostate cancer prevention. Age, race, and genetics are considered factors that cannot be controlled; however, some lifestyle changes might be adapted to diminish the risk of developing the disease. Having regular exercise helps strengthen the cardiovascular system, which improves the body’s overall condition. Following a healthy diet that contains various nutritious sources, limiting red meat, avoiding processed and high-sugar food and beverages also contributes to overall health. Although not all researchers agree, reducing calcium intake is also considered a risk-lowering behavior. Several kinds of research show that some vitamins (Vitamin E and selenium), minerals, and supplements (soy and isoflavones) may reduce the risk of prostate cancer. But it should be noted that these should not be taken without consulting a doctor since they might have risks and benefits.
Sources:
Cancer.org
Cancerresearchuk.org
Prostate.org.au
Prostate Cancer Statistics
The World Cancer Research Fund states that prostate cancer is the second most commonly developed cancer in men after skin cancer and the fourth most widely developed cancer.
It is estimated there will be 268,490 new prostate cancer patients for 2022, about 13.1 percent of all new cancer cases. The study made by the Centers for Disease Control and Prevention shows that prostate cancer is the type of cancer that has the most new cases. About one man in 8 is expected to be diagnosed with prostate cancer during his lifetime.
The most common age group diagnosed with a type of prostate cancer is between 70-74, followed by 65-69 and 75-79. The probability of developing prostate cancer after 70 is 9 percent, while death in the same age group is 2,9 percent. The statistics show that, in terms of race and ethnicity, the black male patients are the largest group diagnosed with a type of prostate cancer, followed by white and then the Hispanic part of the population.
In terms of mortality rates, prostate cancer is the second most common cause of death after lung cancer among men in the US. About 1 in every 41 American men will die of prostate cancer. The expected number of deaths caused by this type is about 34,500, about 5.6 percent of all cancer deaths.
The study shows that between 1999 and 2018, the mortality rate of prostate cancer has shown a steady drop.
Survival rates are estimations based on the statistical outcomes of previous patients with a specific type of cancer. These rates are not certain indicators of a patient’s expected lifespan. Each patient has a personal case. However, scientists use the data to get a clear picture of the disease and classify the nature of different types and stages. Cancer.gov defines the relative rate of survival as an estimate of the percentage of patients who would be expected to survive the effects of their cancer, excluding the risk of death by other causes. According to the data by SEER (Surveillance, Epidemiology, and End Results) gathered from the patients between 2011-2017, five-year the relative rate of survival for prostate cancer is 97.5 percent. The five-year period is calculated starting from the date of the diagnosis.
Scientists assess the survival rate by stage as well. The stage of the cancer at diagnosis refers to the extent of a cancer in the body, determines treatment options and has a strong influence on the length of survival. According to the data analyzed by SEER 74.3 percent of prostate cancer is diagnosed at the local stage (the cancer is found only in the part of the body where it started). 74 percent of the prostate cancer diagnosis is at the local stage (also called stage 1). And the five-year relative survival for localized prostate cancer is 100.0 percent.
13 percent of prostate cancer are regional stage cancer, meaning the cancer has spread outside the prostate to nearby structures or lymph nodes. The five-year relative survival for regional prostate cancer is also 100.0 percent.
7 percent of the cases are at the distant stage which indicates that the cancer has spread to parts of the body further from the prostate, such as bones, liver or lungs. The five-year relative survival for distant prostate cancer is 30.6 percent.
Cancer.org warns that these statistics apply only to the stage of cancer when it is first diagnosed. They do not apply later on if the cancer grows, spreads, or comes back after treatment.
Sources:
Wcrf.org
Cancer.org
Seer.cancer.gov
Sayfa Sonu
cancerstatisticscenter.cancer.org
What are Prostate Cancer Signs and Symptoms?
Most prostate cancers are found early through screening because early prostate cancer does not usually cause symptoms. Some symptoms of more advanced prostate cancer can include:
- Urination problems
- Blood in the urine or semen
- Erectile dysfunction
- Hip, back, and chest pain if the cancer has spread to the bones
- Weakness or numbness in the legs and feet.
These symptoms are more often caused by other issues than prostate cancer, but you should visit your doctor to determine the cause if you experience any of the above symptoms.
Prostate Cancer Symptoms
The prostate is largely made up of muscle fibers and glands, and its main function is to produce semen to deliver sperm. Prostate cancer is a malignant tumor that arises especially from the outer part of the prostate gland and spreads to the inner parts of the prostate as it grows.
There are many symptoms of advanced prostate cancer. The most common symptoms experienced by patients include:
- Intermittent flow during urination and the feeling that the bladder is not completely emptied
- Frequent urination at night and while asleep
- Burning and pain during urination
- Blood in the urine
- Feeling discomfort or pain when sitting due to enlargement of the prostate
- Blood in the seminal fluid released during intercourse or masturbation
If cancer spreads from the prostate gland to other organs, other symptoms may occur. Some of these symptoms include:
- Fatigue
- Difficulty with bowel movements and constipation
- Pain in the back, hips, thighs, shoulders, or other bones
- Unexplained weight loss
- Pain or swelling in the legs or feet
What Causes Prostate Cancer?
Prostate cancer usually shows no signs or symptoms in the early stages. It is one of the most common types of cancer in men after skin cancer. The diagnosis is usually made as a result of urination problems, the most common symptom.
The prostate is largely made up of muscle fibers and glands. Its main function is to produce semen to deliver sperm. Prostate cancer is a malignant tumor that occurs in the outer part of the prostate gland and spreads to the inner parts of the prostate as it grows.
As individuals get older, the risk of getting prostate cancer increases. If a family member carries the BRCA1 or BRCA2 gene, which increases the risk of breast cancer, or if there are individuals with breast cancer in the family, the risk of prostate cancer also increases. Obese men are also more likely to have advanced prostate cancer that is more difficult to treat.
Prostate Cancer Treatment
New advances in prostate cancer treatments are made possible by clinical trials that ensure new therapies and drugs are both safe and effective prior to approval by the FDA. Once approved, these therapies are used to treat patients as the standard of care. For patients in the early stages of prostate cancer, the survival rate is nearly 100 percent. However, new advanced prostate cancer drugs are crucial to develop because once it has metastasized to distant parts of the body, the advanced prostate cancer survival rate is only 30 percent.
Some of the latest treatments for advanced prostate cancer in clinical trials include:
- New methods of a radical prostatectomy
- Immunotherapy
- Hormone Therapy
- Targeted Therapies
Prostatectomy: Advanced Techniques
When prostate cancer is in its early stages where the cancer is only in the prostate gland, surgery is a common treatment option for patients. This type of surgery is not available to those with advanced metastatic prostate cancer. A prostatectomy is a procedure to remove the entire prostate, nearby tissue, and seminal vesicles. In some cases, the lymph nodes closest to the prostate will be removed. There are several methods of prostatectomy, which include:
- Open radical prostatectomy: The prostate is removed when a small incision is made in the lower abdomen or between the scrotum and anus (perineum). In some cases, the lymph nodes are also removed during this procedure. It can be difficult to keep the nerves around the prostate intact or remove the lymph nodes when the incision is made in the perineum.
- Radical laparoscopic prostatectomy: A laparoscope, which is a tube with a light and camera, is inserted in one of the multiple incisions made along the wall of the abdomen. The surgical instruments are used in the other incisions to remove the prostate. It is more likely that the patient will have their nerves undamaged, or lymph nodes removed using this method.
- Robot-assisted laparoscopic prostatectomy: Similar to the radical laparoscopic prostatectomy, several incisions are made through the abdomen and a camera is inserted within one of the incisions, giving the surgeon a 3-dimensional view of the prostate and nearby tissues. Robotic arms are placed in the other incisions and are controlled by the surgeon through a monitor in the surgery room.
Symptoms that patients may experience after one of these procedures include:
- Impotence
- In some cases, an Inguinal hernia occurs within a few years of the surgery and causes a bulging of the small intestine or fat through weak muscles into the groin
- Shortening of the penis by nearly an inch
- Urine or stool leaking from the bladder and rectum
Immunotherapy for Prostate Cancer
Immunotherapy signals the immune system of the patient to attack cancer cells in the body. Substances from the patient or artificially made in a laboratory to strengthen the body’s defenses against cancer. Advanced prostate cancer treatment using immunotherapy typically includes Sipuleucel-T once the cancer has metastasized to other parts of the body. New treatments for advanced prostate cancer and prostate cancer in early stages are being developed in clinical trials, which give access to the latest therapies for cancer patients.
Hormone Therapy for Prostate Cancer
Prostate cancer can grow from male sex hormones, so preventing their production can help stop the growth of the cancer cells. Hormones are made by glands and circulate in the bloodstream. Hormone therapy removes hormones or prevents them from helping cancer cells grow. Androgen deprivation therapy (ADT) is the process of reducing the number of male hormones or prevent them from working by using surgery, drugs, or specific hormones.
Some common forms of hormone therapy in prostate cancer patients include:
- Abiraterone
- Acetate
- Orchiectomy
- Estrogens
- Luteinizing hormone-releasing hormone agonists
- Antiandrogens
- Adrenal gland inhibitors
Targeted Radiation Therapy and PSMA
Targeted therapies are drugs used for late-stage prostate cancer treatment that are able to locate, identify, and attack cancer cells based on their specific characteristics. These drugs avoid normal, healthy cells often causing less side-effects from treatment in patients. PARP inhibitors are used to block enzymes that promote cell growth in the body. Olaparib is a PARP inhibitor used in prostate cancer that targets the enzymes and prevents cancer cells from performing vital cell functions, leading to their death. Targeted therapies are used to treat advanced stage prostate cancer because it is more difficult to treat, or they are used in cancer with mutations in their genes such as BRCA1, BRCA2, MET, HER2, and more.
The prostate-specific membrane antigen (PSMA) is a brand-new method of detecting prostate cancer in patients. The PSMA is injected into the bloodstream and binds to the cancer cells. Doctors are not only able to locate these cells to know exactly where in the body the cancer has spread, but targeted therapies are used to attack these cancer cells that have the PSMA attached to them.
NCI-Supported Research Programs
The National Cancer Institute (NCI) is part of the National Institutes of Health and offers comprehensive information on cancer treatment, diagnosis, research, clinical trials, and more. The NCI also helps support and fund research in cancer through clinical trials, grants, training programs, and other initiatives.
For example, Massive Bio was awarded a contract by the NCI to develop an oncology based artificial intelligence (AI) enabled clinical trial recruitment tool to help prostate cancer and other cancer patients connect to new treatments in clinical trials. This Small Business Innovation Research (SBIR) contract by the National Cancer Institute (NCI) helped to develop and characterize the Deep Learning Clinical Trial Matching System (DLCTMS). The development of the DLCTMS has the potential to enhance clinical trial enrollment and retention across NCI clinical trial networks and beyond.
Personalized Clinical Trials for Prostate Cancer
Prostate cancer clinical trials test new and promising cancer treatments to diagnose, prevent, or treat a disease. Oncology trials are used to find treatments and improve the quality of life in patients. Today’s standard treatment options were once used before their approval in clinical trials. Therefore, patients are getting early access to clinical trial therapies, sometimes years before they are widely available to the public.
Massive Bio’s DLCTMS can help connect you with the clinical trial that is most suitable for your case. Using your medical records and our AI platform, more than 170 clinical algorithms find the clinical trials right for you, which include your location, cancer type, age, subtype, biomarkers, and more.
Sources:
https://www.cancer.gov/types/prostate/research
https://www.cancer.gov/types/prostate/patient/prostate-treatment-pdq
Living and Managing Prostate Cancer
Most men with prostate cancer are diagnosed while the cancer is still in its early stages, when it is tiny and has not progressed beyond the prostate gland. These men have several treatment options to choose from.
Not every man with prostate cancer must be treated right away. If you have early-stage prostate cancer, you should think about your age, general health, and the possibility that the tumor may create issues before determining what to do. You should also consider the potential negative effects of therapy and how likely they are to affect you. Some men, for example, may desire to postpone potential side effects such as incontinence or erection issues for as long as feasible. Other men are less concerned about these side effects and more concerned about removing or destroying the cancer.
If you’re older or have other major health issues, and your cancer is slow growing, you might find it useful to think of prostate cancer as a chronic condition that won’t kill you but may create symptoms you’d rather avoid. You could consider attentive waiting or active monitoring rather than therapies that are likely to produce serious adverse effects, such as radiation and surgery. Of course, age is not always the best basis for your decision. Many men are in good mental and physical fitness at the age of 70, although other younger men may not be.
If you are younger and otherwise healthy, you might be more willing to accept possible side effects of treatment if they offer you the best chance for cure. Most doctors believe that surgery, external radiation, and brachytherapy all have about the same cure rates for the earliest stage of prostate cancers. However, each type of treatment has risks and benefits that should be considered.
Coping With Physical Side Effects
Prostate cancer may cause no signs or symptoms in its early stages.
Prostate cancer that’s more advanced may cause signs and symptoms such as:
- Trouble urinating
- Decreased force in the stream of urine
- Blood in the urine
- Blood in the semen
- Bone pain
- Losing weight without trying
- Erectile dysfunction
Make an appointment with your doctor if you have any persistent signs or symptoms that worry you.
Coping With Sexual Side Effects
Sexual dysfunction is a common complication of prostate cancer. A prostate cancer diagnosis lowers sexual desire and frequency of sexual intercourse on its own. Erectile dysfunction is exacerbated further by hormone treatment to inhibit testosterone and neurovascular bundle damage induced by radical prostatectomy.
One of the most pressing concerns for individuals with localized prostate cancer is the preservation of erectile function. The prognosis of erectile dysfunction following radical prostatectomy varies depending on the preservation of the neurovascular bundle, patient age, and prior erectile condition.
Coping With Emotional and Social Effects
Men respond in all kinds of ways to being diagnosed and living with prostate cancer. You may feel a wide range of emotions and they might change very quickly.
- Shock, fear or anger: You could feel any or all these things when you’re told you have prostate cancer.
- Denial: If you feel well, you may find it difficult to accept that you have prostate cancer.
- Frustration and disappointment: The way you think about yourself, your life and your plans might have changed.
- Stress: It can be difficult to decide what treatment to have and you might feel stressed.
- Worries about side effects: If you have side effects like erection, urinary and bowel problems, then coping with these could also make you feel down or worried.
- Sense of loss: Hormone therapy can cause physical changes to your body, such as putting on weight, reduced physical strength, or changes to your sex life. This might make you feel very different about your body and cause a sense of loss.
- Changing identity: Sometimes men say they feel less of a man because of their diagnosis and treatment. Some men feel that their role in the family has changed – for example, because they’ve had to stop working.
- Mood swings: Hormone therapy can make you feel emotional and down. It can also cause mood swings, such as getting tearful and then angry.
- Anxiety: Some men worry about getting their prostate specific antigen (PSA) test results. The PSA test is used to monitor your cancer if you’re not having treatment straight away or to check how successful treatment has been. Even after treatment has finished some men feel anxious and find it hard to move on and think about the future.
- Feeling alone: You might feel isolated, especially if your treatment has finished and you’re no longer seeing your doctor or nurse.
All these are very normal ways to feel. These feelings may stay with you, but some men find they gradually change with time.
Caring for a Loved One With Cancer
When it comes to caring for someone with prostate cancer, there is no one-size-fits-all solution.
Caregivers are on their own journey while individuals begin their prostate cancer journey. They, too, require assistance, and addressing their requirements becomes a valid objective.
Here are some tips to get started in your caregiver role:
- Go to doctor’s appointments. Take notes. Research shows that people coping with cancer may not hear everything and miss important information about their care.
- If asked, help explore treatment options.
- All prostate cancer treatments have side effects; it is important to discuss with your loved one how you’ll be involved in supporting him.
- Take time to do what nurtures you. Take a walk, talk to friends, read and play music – you are important, and your well-being matters too.
- If your loved one is overwhelmed, talk to him and his doctor about counseling.
- Remember that both of you will experience a wide range of emotions. Do not suppress these feelings, talk about them together and know that they are normal.
Talking With Your Healthcare Team About Side Effects
Side effects vary from person to person and are treatable. Being aware of side effects and communicating with your health care provider when they occur is essential for managing them. Report them straight away, rather than waiting until your next checkup.
Side effects may occur and linger throughout treatment or arise in post-treatment.
Side effects may include:
- Chemotherapy-induced nausea and vomiting
- Fatigue
- Mucositis (mouth sores)
- Neuropathy (nerve damage)
- Neutropenia and infections
- Diarrhea
- Constipation
- Hair loss
- Chemobrain (forgetfulness or difficulties concentrating)
- Change in appetite and/or weight
- Lymphedema
- Rashes or dry skin
Good communication with your doctor will help improve the quality of the care you receive. The following tips may help you communicate better with your health care team.
- Start a health care journal.
- Prepare a list of questions and write down your doctor’s answers.
- Bring someone with you to your appointments.
- Keep important papers together in an accessible file.
- Talk to your doctor about a second opinion
Sources:
https://www.urologyhealth.org
https://www.cancercare.org
https://www.ncbi.nlm.nih.gov
https://prostatecanceruk.org
How Is Prostate Cancer Diagnosed?
Prostate cancer detection is most common in men during routine screenings performed by doctors. Most patients do not experience symptoms until the cancer is in advanced stages. The diagnosis and early detection of prostate cancer are crucial because surgery to remove the tumor can only be done if it hasn’t spread outside the prostate.
Doctors confirm a prostate cancer diagnosis through several methods after a physical exam, such as:
- Digital rectum exam (DRE)
- PSA blood test
- Magnetic Resonance Imaging (MRI)
- Biopsy of the prostate
- Transrectal ultrasound (TRUS)
Digital Rectum Exam
DRE is the screening test performed on men over the age of 50 or those at risk of prostate cancer. The doctor will insert a lubricated finger into the rectum and feel for hard areas or bumps on the prostate that could be cancer. If prostate cancer is already suspected, the DRE can determine whether the cancer is on one or both sides of the prostate, and if it has spread beyond the prostate.
PSA Blood Test
Prostate-specific antigen (PSA) is a protein made from the prostate gland that is mostly in semen and a small amount in the blood. PSA can be measured through the blood by nanograms per milliliter (ng/mL). The higher the PSA levels are, the greater the risk of prostate cancer.
Doctors often perform a PSA blood test to screen men who don’t have prostate cancer symptoms or those who have symptoms that may or may not be caused by prostate cancer. The most often used PSA levels to indicate a patient needs further testing to diagnose prostate cancer are 4 ng/mL or higher. However, some doctors may still perform additional testing at lower levels, such as 2.5-3ng/mL. Even at 4 ng/mL, there is only a 25% chance of prostate cancer being present. If the PSA levels are higher than 10, the risk increases to 50%.
The PSA diagnostic test is used in some men who have been diagnosed with prostate cancer already. The test results can be used when determining the stage of the disease. PSA tests can also be used throughout treatment to monitor how well the treatment is working, or after treatment is completed to watch for a possible recurrence of prostate cancer.
MRI scan
MRI scans create images of tissues in the body using magnets and radio waves. Doctors are able to clearly view the prostate and surrounding tissues. An MRI for prostate cancer diagnosis is commonly used to:
- Help locate where the tumor is located exactly to help with an upcoming biopsy or during a biopsy of the prostate
- Determine the stage of cancer
- Detect if the cancer has spread to nearby tissues
In some cases, different methods are used to increase the accuracy of the MRI. Gadolinium can be injected prior to the imaging test to contrast the MRI for clearer results. Doctors also sometimes use a probe called an endorectal coil that is placed in the rectum.
Biopsy
Prostate cancer can be diagnosed by a biopsy, which is the most used method of diagnosing cancer. A small amount of tissue is removed from the tumor and examined under a microscope. In many cases, an initial imaging test is done, and If cancer is suspected, a biopsy is performed to confirm the diagnosis.
A Transperineal Biopsy
Needle biopsy for the prostate through the skin behind the testicles. Samples of tissue are taken to a lab to be seen under a microscope. This type of biopsy can detect prostate cancers that are missed in other screening tests.
Transperineal biopsies can be used for all patients but can benefit patients who have:
- Previous infection after a transrectal biopsy
- Inflammatory bowel disease
- Prostatitis
- Rectal bleeding complications after biopsy
- Negative transrectal biopsy with suspicion of anterior prostate tumor
A Transrectal Biopsy
Transrectal ultrasound (TRUS) guided biopsy is performed by a doctor who collects a biopsy through the rectum using a transrectal ultrasound scanner. An MRI may be performed prior to a TRUS.
TRUS biopsies are used in those with prostate cancer symptoms or for follow-up testing in men with high PSA levels or abnormal DRE results. Because prostate tumors are small, they can be difficult to locate during biopsies. Nearly 2 out of 3 initial TRUS biopsies are negative, but tests are often repeated over time.
Further Testing for Advanced Cancer
Additional testing can determine the available prostate cancer treatment options, which vary depending on the stage of cancer and the extent of metastasis. Additional testing can also help determine if patients are eligible for prostate cancer clinical trials with unique enrollment criteria.
Massive Bio specializes in finding advanced clinical treatments for every prostate cancer type. If you’ve been diagnosed with any of the prostate cancer subtypes, we’re here to help. If you don’t know which type of prostate cancer you have, that’s okay. Additional testing can help you determine your exact diagnosis.
- Adenocarcinoma
- Transitional Cell Carcinoma
- Small Cell Carcinoma
Staging
There are several factors in determining a prostate cancer patient’s stage, including the PSA levels, grade of your tumor from the results of the biopsy, whether the cancer has spread outside the prostate to distant organs or bones. The stages of prostate cancer are:
- Stage 1: The tumor cannot be felt during the examination or seen during imaging. It can be found when surgery is performed for another medical condition.
- Stage 1a: The tumor is discovered incidentally during a surgical procedure used to treat prostatic hyperplasia, which is the abnormal growth of benign prostate cells. Cancer is found in only 5% or less of the tissue removed.
- Stage 1b: The tumor is found accidentally during BPH surgery. Cancer cells are detected in more than 5% of the tissue removed.
- Stage 1c: The tumor is found during a needle biopsy that was performed because of an elevated PSA level.
- Stage 2: The tumor appears to be confined to the prostate. Due to the size of the tumor, the doctor can feel it during the digital rectal exam. Cancer may also be seen with imaging.
- Stage 2a: The tumor has invaded one-half (or less) of one side of the prostate.
- Stage 2b: The tumor has spread to more than one-half of one side of the prostate, but not to both sides.
- Stage 2c: The cancer has invaded both sides of the prostate.
- Stage 3: The tumor has grown outside the prostate. It may have spread to the seminal vesicles.
- Stage 3a: The tumor has developed outside the prostate; however, it has not spread to the seminal vesicles.
- Stage 3b: The tumor has spread to the seminal vesicles.
- Stage 4: The tumor has spread outside the prostate. It may have spread to areas such as the bladder or back passage (rectum). Or it may have spread further, for example to the bones.
Sources:
https://www.cancer.org
https://www.cancerresearchuk.org
https://www.cancerresearchuk.org
https://www.pcf.org
Prostate Cancer Staging
Staging refers to the process of determining if cancer has spread outside the prostate or to other regions of the body. The stage of the disease is determined by the information obtained during the staging phase. It is critical to understand the stage to plan treatment. The findings of tests used to identify prostate cancer are frequently used to stage the illness as well. Staging tests for prostate cancer may not be performed unless the patient exhibits symptoms or evidence indicating the disease has progressed, such as bone discomfort, a high PSA level, or a high Gleason score.
The following tests and procedures may also be used in the staging process:
- Bone scan: A bone scan is a test to see if there are any fast-dividing cells in the bone, such as cancer cells. A trace amount of radioactive material is injected into a vein and circulated in the bloodstream. The radioactive material accumulates in the bones of cancer patients and is detected by a scanner.
- MRI (magnetic resonance imaging): A technique that uses a magnet, radio waves, and a computer to create a sequence of detailed images of locations within the body. This method is also known as nuclear magnetic resonance imaging (NMRI).
- CT scan (CAT scan): A process that produces a series of detailed images of parts of the body taken from various angles. A computer linked to an x-ray machine creates images. To make the organs or tissues show up more clearly, a dye may be injected into a vein or ingested. This is also known as computed tomography, computerized tomography, or computerized axial tomography.
- Pelvic lymphadenectomy: A surgical operation used to remove lymph nodes from the pelvis. A pathologist examines the tissue under a microscope in search of cancer cells.
- Seminal vesicle biopsy: Using a needle, fluid is removed from the seminal vesicles (glands that produce sperm). Under a microscope, a pathologist examines the fluid for cancer cells.
- ProstaScint scan: A test to determine whether cancer has spread from the prostate to other regions of the body, such as the lymph nodes. A minimal amount of radioactive material is injected into a vein and circulated. A scanner detects the radioactive material once it binds to prostate cancer cells. The radioactive material appears as a bright spot on the image in places with a high concentration of prostate cancer cells.
How Many Staging Types Are Determined for Prostate Cancer?
The cancer stage is determined by the results of staging and diagnostic tests, such as the prostate-specific antigen (PSA) test and the Grade Group. The Gleason score is calculated using tissue samples obtained during the biopsy. The Gleason score, which runs from 2 to 10, reflects how different cancer cells appear under a microscope from normal cells and how likely it is that the tumor will spread. The lower the number, the more cancer cells resemble normal cells and are therefore more likely to develop and spread slowly.
Gleason Score for Grading Prostate Cancer
The Gleason score can vary between 6 and 10. The higher the Gleason score, the faster the cancer will develop and spread. A Gleason score of 6 indicates that the cancer is of low grade; a score of 7 indicates that the cancer is of medium grade; and a score of 8, 9, or 10 indicates that the cancer is of high grade.
For example, if the most common tissue pattern is grade 3 and the secondary pattern is grade 4, it means that much of the cancer is grade 3 and less of it is grade 4. The grades are combined for a Gleason score of 7, indicating that the cancer is of medium severity. The Gleason score can be expressed as 3+4=7, 7/10, or a total Gleason score of 7.
Prostate Cancer Stages
The following stages are used for prostate cancer:
Stage I
- Cancer is exclusively present in the prostate. The cancer is not felt during a digital rectal exam and is discovered by a needle biopsy performed for a high PSA level or in a sample of tissue taken after surgery for other reasons. The PSA level is less than 10 and the Grade Group is 1; OR the cancer is felt during a digital rectal exam and located in half or less of one side of the prostate. The PSA level is less than ten, and the grade level is one.
Stage II
- Stage IIA: Cancer is exclusively present in the prostate. One-half or less of one side of the prostate is cancerous. The prostate-specific antigen (PSA) level is at least 10 but less than 20, and the Grade Group is 1; OR cancer is diagnosed on more than half of one side of the prostate or both sides of the prostate. The PSA level is under 20, and the Grade Group is 1.
- Stage IIB: Cancer is exclusively present in the prostate. Cancer can be discovered on either one or both sides of the prostate. The level of prostate-specific antigen is less than 20, and the Grade Group is 2.
- Stage IIC: Cancer is found in the prostate only. Cancer is found in one or both sides of the prostate. The prostate-specific antigen level is less than 20 and the Grade Group is 3 or 4.
Stage III
- Stage IIIA: Cancer is found in the prostate only. Cancer is found in one or both sides of the prostate. The prostate-specific antigen level is at least 20 and the Grade Group is 1, 2, 3, or 4.
- Stage IIIB: Cancer has spread from the prostate to the seminal vesicles or to nearby tissue or organs, such as the rectum, bladder, or pelvic wall. The prostate-specific antigen can be any level and the Grade Group is 1, 2, 3, or 4.
- Stage IIIC: Cancer has been discovered on one or both sides of the prostate and may have progressed to the seminal vesicles or surrounding tissue or organs such as the rectum, bladder, or pelvic wall. The prostate-specific antigen might be of any amount, with a Grade Group of 5.
Stage IV
- Stage IVA: Cancer is found in one or both sides of the prostate and may have spread to the seminal vesicles or to nearby tissue or organs, such as the rectum, bladder, or pelvic wall. Cancer has spread to nearby lymph nodes. The prostate-specific antigen can be any level and the Grade Group is 1, 2, 3, 4, or 5.
- Stage IVB: Cancer has spread to other parts of the body, such as the bones or distant lymph nodes.
Sources:
https://www.cancer.gov
https://www.mayoclinic.org
Risk Factors and Prevention of Prostate Cancer
Prostate cancer occurs in the pancreas, a small gland shaped like a walnut that produces seminal fluid and transports sperm. This cancer is one of the most common types of cancer in men. Most subtypes are indolent, meaning they develop slowly over several years. However, there are some types of prostate cancer that are aggressive and spread quickly. A prostate cancer diagnosis in early stages can increase the likelihood of successful treatment. This can be complicated due to a lack of signs and symptoms present in the early stages for most patients.
There are several known prostate cancer causes and risk factors that can help individuals understand their risk of prostate cancer. The two known predisposing factors of prostate cancer from researchers are genetic mutations and acquired mutations. These mutations cause cancer by making changes in the DNA of prostate cells. Changes in genes that aid in cell growth and reproduction can lead to cancer cells growing out of control. Genes that repair DNA and cause cells to die are called tumor suppressor genes. Mutations can also cause to stop working properly and lead to the spread of cancer.
What are the Risk Factors of Prostate Cancer?
Risk factors are anything that increases the likelihood of someone developing cancer. It is important to note that because risk factors for cancer are present, it does not guarantee that the disease will develop. If someone does not have any risk factors present, there is still a chance they can develop cancer. Talk with your doctor to learn more about your individual risk and if you can make lifestyle choices to aid in preventing cancer.
Roughly 60 percent of all prostate cancer cases are in men over the age of 65. Older patients may have limitations in their prostate cancer treatment options. Therefore, these prostate cancer risk groups should follow the proper screening guidelines and be aware of all possible signs and symptoms. The older you get; the risk of prostate cancer increases.
Other prostate cancer risk factors include:
- Genetic factors
- Racial factors
- Obesity
Genetic Factors
Nearly 20 percent of all prostate cancer cases are considered Familial prostate cancer, which develops due to various shared genes and lifestyle factors.
Hereditary prostate cancer is an inherited risk from the family when mutations in one or more genes are passed down to each generation. Although rare and only occurring in 5 percent of all prostate cancers, hereditary prostate cancer increases a family member’s risk of developing prostate cancer by 2 or 3 times. This risk multiplies by each family member that is diagnosed with prostate cancer. If you have a prostate cancer genetic risk, you should talk with your doctor about how often you should receive a prostate cancer screening. In most cases of hereditary prostate cancer, inherited mutations are in the following genes:
- BRCA1 and BRCA2
- CHEK2, ATM, PALB2, and RAD51D
- HOXB13
- DNA mismatch repair genes (MSH2, MSH6, MLH1, and PMS2)
- RNASEL (formerly called HPC1)
To be considered at high risk of hereditary prostate cancer, you must have one of the following in your family history:
- 3 or more family members who have had prostate cancer
- At least 2 first-degree family members under the age of 55 with prostate cancer
- Prostate cancer on one side of the family in 3 generations
Racial Factors
African American men historically are diagnosed with prostate cancer at a higher rate than any other race. Also, the prostate cancer prognosis and survival rate is often less favorable for men of African ancestry. Geographically, prostate cancer is most common in North America, Europe, and in recent years, urban environments in Asia.
Obesity
Similar to other cancer types, doctors suggest maintaining a healthy lifestyle, which includes a balanced diet. While studies have not shown a definitive correlation, men who consume a lot of dairy products and calcium are believed to have a slight increase in their chance of having prostate cancer. However, these reports should not discourage people from consuming dairy products and calcium as they have various health benefits.
Studies have shown there is not a direct correlation between obesity and prostate cancer. It is believed that cases of prostate cancer in obese men are usually of aggressive subtypes of prostate cancer, instead of prostate cancers that slowly develop. Aggressive types of this cancer are likely to become metastatic prostate cancer, or advanced cancer that has spread to distant tissues or organs in the body.
Prevention: Ways to Reduce Risk
Doctors have several suggestions for prostate cancer prevention and limiting one’s risk. The ways to prevent prostate cancer are not guaranteed, even without a family history of prostate cancer or risk factors present. However, you can limit your risk through lifestyle choices such as a healthy diet and physical activity. It is also recommended to avoid excessive smoking and alcohol consumption. If you are at risk for prostate cancer, is it important to go through yearly screening tests such as a PSA test or rectal examination.
Sources:
https://www.cancer.net
https://www.cancer.org
Prostate Cancer Clinical Trials
What are clinical trials?
Clinical trials are research studies performed in volunteer people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the vital method to find out if a new treatment, therapy technique, drug combination, diagnosis technology, a diet, a medical device (pacemakers, etc.) or a strategy for preserving the patient’s quality of life is effective, safe, and viable in people. The aim of these trials is to find out if a new treatment or procedure is safe, has side effects, works better than the currently used treatment, and how it affects the quality of life. The trials are thoroughly designed, reviewed, and completed, and should be approved before they can start.
The clinical trials intend to gather data and insight on the below areas:
Risks and causes: How genetics, lifestyle and other factors increase people’s risk of cancer
Prevention: Using drugs or lifestyle changes to reduce the risk of cancer
Screening: Tests for people in high-risk groups, or the general population
Diagnosis: Creating new drugs or combining them, as well as deciding on dosage or ways of treatment, and new types of treatment
Controlling symptoms or side effects: New drugs or complementary therapies
Support and information: For cancer patients and their caregivers, families, and friends
The clinical trials help create healthy and innovative alternatives for patients with specific conditions or stages of various diseases. With the data collected through the clinical trials, scientists can determine whether the tested drug, procedure or device works or not. Sometimes the trial may not provide the expected results, however science still benefits from them since they have the chance to rule out the tested option and tackle new ones. On the other hand, as the Prostate Cancer Fund states, clinical trials play a vital role in moving new treatments to patients who need those most, securing data so regulatory approvals can be obtained and new drugs can move into widespread clinical practice. The cancer patients who choose to participate in clinical trials are making a great contribution to treatment science as well as to those who suffer the same disease.
In the US, for a clinical trial to begin upon the FDA (US Food and Drug Administration) approval, an initial laboratory test and the following study in animals should be completed to assess the safety and efficacy of a potential therapy. When the studies produce favorable results, the FDA gives approval for a test in humans.
According to the numbers provided by Prostate Cancer Fund, there are 100 Phase III drug trials and more than 500 Phase I/II trials related to prostate cancer treatment in progress in the United States alone.
Types of Clinical Trials
There are two main types of clinical trials:
Interventional trials: These trials’ aim is to gather more data about a particular intervention, or a treatment. The participants of the trial are assigned in different treatment groups by a computer, and the results are compared by the researchers.
Observational studies: In this type of trial, the participants are not assigned in different groups, and the treatments they have are not influenced. The researchers focus on observing what happens to people in different situations.
Under these two main types of clinical studies, there are various types of trials. Those can be listed below:
Pilot studies and feasibility studies: These studies are small versions of studies performed sometimes before the large-scale trials take place.
Pilot studies are small versions of the main study. They are designed and performed to see if different elements of the main study work harmoniously. When the pilot study provides answers for the main study, the researchers include this information in the results of the main study.
The feasibility studies’ aim is to collect information about the possibility of the main study, not to answer questions focused on the main trial. The researchers collect data about factors such as the willingness of the patients and doctors’ participation, the length of the study to collect data, analyze them and create helpful insights.
Prevention trials: These trials are run to see whether a specific treatment is helpful to prevent cancer. Thus, the participants are chosen from individuals with no cancer. Prevention trials can focus on people with a higher risk of cancer (such as people with a family history of cancer) than normal or can include the general population.
Screening Trials: These trials test people for the early sign of cancer before they develop any symptoms. Like prevention trials, screening trials can focus on a high-risk cancer group as well as the general population. The trials can be designed to see if the tested screening method is reliable enough to detect particular types of cancer. They can also be designed to see if early detection has any benefits for the individuals.
Treatment trials: These are the trials that are designed in various stages called phases. In the early phases, the researchers try to find out if the new treatment is safe and has side effects. In the later phases, they compare the new treatment with current ones and try to find out if it produces better results. Sometimes, these trials compare two or more treatments. In this case, the patients are randomly put into treatment groups. The randomized trials are considered the best method to collect information on how well a new treatment works.
Multi-arm multi-stage (MAMS) trials: This type of trial has a standard treatment group, called the control group, along with several treatment groups. During the MAMS, the control group is constant while the other treatment groups may change as the trial develops. According to the course of the trial, the researchers might stop or continue recruiting new patients to a particular group. The reason to stop might be because they have enough participants to get reliable results or because the early results show that the treatment is not working as well as they expected. And as MAMS work in a comparison dynamic, they might add new treatment groups if a new drug becomes available. This helps researchers adapt to the developments in the medical environment and continue their studies without the need to design a new trial from scratch.
Cohort Studies: This observational type of study usually takes place to assess risk factors. The researchers might follow a group of people (a cohort) with no cancer over a period and observe if they develop the disease or not. Then they make further analysis to determine common factors among the group who developed cancer. Cohort studies take a long time, thus expensive, and are applied when it wouldn’t be possible to test a theory in any other way.
Case control studies: Another observational type of study that works in a way opposite of the cohort studies. In case control studies, two groups of people are recruited: one with the disease (case group), and one with not (control group). Compared to cohort studies, they are cheaper and faster, but sometimes less reliable. To get reliable outcomes as much as possible, the researchers design two groups with the same general factors such as age and gender. Then they compare each group retrospectively in terms of exposure to risk factors. The participants are asked about their exposure history to collect data. But memory is often not a healthy source of information, which makes case control studies less reliable. Another downside of case control studies is in the association-cause equation. Although both the association and cause might be present that does not necessarily mean the factor is the cause of the disease. For example, the outcome of the case control study might show that the lower a person’s income, the higher the risk of developing cancer. But in this case, low income cannot be considered as a risk factor and direct cause of cancer. However, the insight might be that lower income groups have a poor diet or a tendency to smoke.
Cross sectional studies: The aim of cross-sectional studies is to see who has been exposed to a risk factor and who developed cancer and detect a link between these two. These studies can be carried out over a short period of time or at one point in time. Although they are quick and cheap, the results are often less useful. When researchers find a possible link between tested elements, they then switch to a case control study or a cohort study for more detail.
The phases of clinical trials
There are three main phases of clinical trials, numbered from 1 to 3. Some trials might also have an earlier stage called phase 0, and some might have an additional phase 4 done after the tested drug is licensed.
Phase 0: The number of participants is small, between 10-20, and a low dose of the treatment/drug is tested. The tested drug is not expected to cure the disease, and the participants are less likely to present side effects. The aim in this phase is to find out if the drug behaves as expected based on the laboratory studies. The researchers look for answers to questions such as what happens to the drug in the body, whether it reaches the cancer cells, and how cancer cells respond to it. At this phase, the researchers might ask for extra scans or blood samples and biopsies for more elaborate answers.
Phase 1: The number of participants is again small, generally between 20-50. The aim is to judge the safe dosage, identify the side effects, what happens to the drug in the body, and if the treatment is helping to scale down the cancer. Researchers collect blood samples to see how the body copes with and gets rid of the drug. The occurrence and the timing of the side effects are recorded. If the dosage tested on the first group of patients proves safe, the scientists might prefer dose escalation for upcoming groups, meaning that they carry on the study with a slightly higher dose. The aim here is to find out the perfect dosage, identify the side effects coming with the tested dosage and the patients’ comfort. So, the tests might go on with an increase in dosage in time, until the best dose is decided on.
Phase 2: The number of participants is higher, sometimes over 100. These trials can be for a specific type of cancer, as well as different types. In phase 2, a new treatment can be compared with a current treatment, or with a placebo (dummy drug). The aim in phase 2 trials is to see if the treatment works well enough to be tested in phase 3, which types of cancer it works for, more on side effects and how to manage them, and more on the dosage adjustment. Sometimes, phase 2 trials can be designed in randomized nature.
Phase 3: Mostly designed as randomized, phase 3 of trials are large-scale, including hundreds or thousands of participants (sometimes from different hospitals and even countries). The new treatment is compared with the most effective standard treatment, in terms of effectiveness, the dosage, frequency or the method (such as radiotherapy). The aim in phase 3 is to find out which treatment works best for a particular type of cancer, more about side effects, and effects on a patient’s quality of life.
Phase 4: The scale might vary between medium to large, and it usually focuses on one type of cancer, although sometimes more. It takes place after the drug has been shown to work and has been licensed. The aim here is to find out more about the side effects and safety of the drug, see what the long-term benefits are, and how well the drug works when it is more widely used.
The requirements for clinical trials
The researchers look for a set of eligibility criteria in patients to enroll them to trials as participants. That is because they try to group as many patients as possible with similar conditions such as age, type and stage of cancer, previous treatments, and general health to have more reliable results. This helps them make healthier observations and improve the effectiveness of the tested treatment based on solid data. The eligibility criteria are clearly identified in the trial protocol and written with specifics.
Type of cancer: Most of the trials only enroll patients with a particular type of cancer, so that they can find out if a treatment works for the type in question. Because different types of cancer have different nature, and successful treatment might not work for others. When two types of cancer respond to a treatment in the same way, the trial opens to the patients who have those two cancers (such as stomach and esophageal cancer).
Stage of cancer: Stage is an indicator of how big and spread the cancer is. Many trials are only open to patients with a particular stage of cancer.
Previous treatment: The requirement may change in every trial; some might look for patients who have a specific treatment prior to the tested one, while some look for people who had none before, or currently undergoing another treatment.
Age: Although there are trials focusing specifically on children, the researchers usually want to make sure that all the participants are over 18. The age requirement changes based on the nature of the tested treatment, and sometimes the intensity.
General health: In the trial protocols, this requirement is generally called performance status. Although there are different scales such as Karnofsky performance status and the Lansky scale, the most commonly used one is set by the World Health Organization (WHO).
Other medical conditions and life expectancy: Some trials (usually focusing on the early stages of cancer) require patients to have more than a particular number of years. The idea behind this is to rule out patients who might have other life-threatening conditions, so that they can observe and get results in the expected period set at the beginning of the trial.
Are clinical trials safe?
Now let’s start with the benefits of participating in a clinical trial. Many patients who participate in clinical trials say that they feel more in control of their life, health care, and medical challenges. They also mention that having possible access to a treatment before it is widely available is a true advantage. They feel happy to have the chance to help others to get better and be an active participant in the advancement of medical science. They report a growth in their network in terms of support groups and resources. And the fact that they may be provided with advanced medical care and more frequent check-ups as part of the treatment makes them feel taken care of.
When people or their loved ones are diagnosed with cancer, they immediately look for a solution. And when they see the option for a clinical trial, they usually hesitate, question the risk of harm and have doubts about the treatment or survival rates. That is very normal. These concerns are real and valid.
Let us go over the concerning areas. It is true that the tested new treatment may cause side effects that are discomforting, that it may prove insufficient or ineffective, that you might be assigned to the control group (which takes the standard or placebo treatment), or the experience itself might be a burden with the hospital visits, scheduling or staying at the hospital. You may also have concerns about safety. This is such a valid concern that Congress has passed a law to protect the trial participants. Under this law, every clinical investigator is required to monitor and make sure that every participant is safe. The Federal Government enforces that the clinical trials follow a careful study plan or protocol that describes what the researchers do and makes sure they explain every detail to the participants. The medical and personal information of the patients is also strictly protected. The required informed consent forms participants sign prior to the trial gives them a chance to leave the trial at any phase or time they feel uncomfortable without medical consequences. There are institutions such as the Institutional Review Board (IRB) and Data and Safety Monitoring Committee that closely observe and supervise the clinical trials at every phase.
What is a placebo effect?
An essential part of all good clinical trials, placebo effect is the measurable psychological or physical effect that a placebo treatment (sometimes called a dummy drug or a sugar pill) has on an individual. In the history of clinical trials, researchers first compared two groups to test the effectiveness of a drug: a group who took the medication and a group who took no medication. However, along the development of research sciences, the researchers discovered that even taking the dummy drug (an empty tablet with no active ingredients) can produce positive impacts. Placebos are known to reduce symptoms of various conditions such as depression, anxiety, fatigue and Parkinson’s disease. That is why they started designing the clinical trials with an added third group: the placebo group. Now, for a drug to be approved, it has to produce a greater effect than the placebo drug. The placebos are rarely used in clinical cancer trials, and when used, the participant is fully informed about it.
How Do We Help Prostate Cancer Patients?
Massive Bio offers an independent cancer treatment analysis as well as clinical trial matching for prostate cancer patients. Our patient advocates work closely with patients to gather information on their current medical status, and then provide a list of options from available cancer clinical trials close to your home.
We can also provide a second opinion through our Virtual Tumor Board from cancer specialists. The Virtual Tumor Board (VTB) is comprised of highly specialized oncologists from nationally recognized Cancer Centers of Excellence. In just 7-10 days after receiving your medical records, we can get you a treatment plan without having to travel far distances and use your valuable time.
There are approximately 2,595 prostate cancer clinical trials that are currently patients in the United States right now, and more than 5,300 all over the world. If you are not sure which one is a match, consult your doctor for details and see if there is an option for your type of cancer. If you’d like to explore your options at Massive Bio, our team of oncology nurses and our artificial intelligence based clinical trial matching system will find the best option for you.
Sources:
nia.nih.gov
cancerresearchuk.org
who.int
medicalnewstoday.com
clinicaltrials.gov