About this questionnaire. We are building your Clinical History by asking you 32 questions. Your answers to your Clinical History will determine which studies you may be eligible to join, and which you are not.
How old are you, in years?
Adenocarcinoma is the most common type of prostate cancer, representing about 95% of all cases. If your cancer is adenocarcinoma mixed with other types of cancer (such as small cell or neuroendocrine), but most of the cancer is “adenocarcinoma”, answer “adenocarcinoma.” There are two subtypes of adenocarcinoma- acinar adenocarcinoma and ductal adenocarcinoma.
Other types of prostate cancer are rare, and include neuroendocrine tumors, small cell carcinomas, transitional cell (urothelial), squamous cell, sarcoma, and carcinoid.
Prostate-specific antigen (PSA) is a protein produced in the prostate, a small gland that produces seminal fluid in men. The PSA test is a blood test that measures how much of this protein is in a man’s blood. The result is given as a number, usually in nanograms per milliliter (ng/mL).
If your PSA score is higher than normal, this could be a sign of a problem with the prostate, such as inflammation of the prostate, benign prostatic hyperplasia (an enlarged prostate), or prostate cancer.
In the past, PSA levels of 4.0 ng/mL and lower were considered normal. However, some individuals with PSA levels below 4.0 ng/mL have prostate cancer, and many with PSA levels between 4 and 10 ng/mL do not have prostate cancer.
Testosterone is a male sex hormone that is produced by the testicles. It plays an important role in the development of male sexual characteristics, and the growth and function of the prostate gland.
Testosterone levels in the body are measured through a blood test called a serum testosterone test. A “normal” testosterone reading may fall between 300 and 1,000 nanograms per deciliter (ng/dL), but some patients in prostate cancer treatment will have numbers outside of this range.
Higher levels of testosterone may promote the growth and spread of prostate cancer. A common treatment for prostate cancer involves reducing the level of testosterone in the body through hormone therapy or orchiectomy (surgical removal of the testes.) The goal of this therapy is to lower testosterone levels to "castrate" levels, which is generally less than 50 ng/dL. (1.73 nmo/L).
When you get a biopsy of your prostate, the pathologist reports two Gleason grades (each ranging from Grade 1 to Grade 5), based on the appearance of the cancer cells in the tissue.
Add these two numbers together to get your Gleason score, which will be between 2 and 10. A higher Gleason score suggests a more aggressive cancer.
For example, you may be told that your prostate cancer is Gleason Grade 3 and Gleason Grade 4. Add these numbers together to get your Gleason score of 7.
“Metastasis” means that your cancer has spread from its original location to other parts of your body. In prostate cancer, cancer cells can break away from the original tumor in the prostate gland and enter the bloodstream or lymph vessels and travel to other parts of the body. Once they get to a new spot, they can start to grow and form a new tumor there.
It is common for prostate cancer to metastasize to the bones. It can also spread to the lymph nodes in the groin area, distant lymph nodes, or the liver, lungs, or brain.
Prostate cancer can metastasize (spread) to different parts of the body. The most common site where it spreads to is the bones. Up to 90% of men with metastatic prostate cancer have it in their bones.
Prostate cancer also spreads to the lymph nodes. It may first spread to the lymph nodes in the pelvic area, and then spread to lymph nodes in other parts of the body such as the neck and armpits.
Metastasis to the lungs and liver is less frequent. Rarely, prostate cancer can spread to other body organs such as the brain or adrenal glands.
Prostate cancer can spread to more than one spot in your body.
Brain metastasis is a rare complication of prostate cancer. Of all the cases of prostate cancer that metastasize, very few spread to the brain.
A brain metastasis is considered stable when it is not getting larger or changing in appearance. No new spots of metastasis are appearing. The individual is not developing any new neurological symptoms, and their symptoms are not getting worse.
Active brain metastasis means that the tumor in the brain is getting larger or becoming more aggressive. The patient may get new neurological symptoms, or existing symptoms such as headaches, seizures, or neurological deficits are getting worse. New areas of metastasis may appear.
Treatments for prostate cancer include radiation, surgery, non-surgical procedures (cryotherapy, HIFU), hormone therapy, and orchiectomy.
Other treatments are chemotherapy, radiopharmaceuticals, targeted therapies (PARP inhibitors), and immunotherapy, including Keytruda and Provenge.
Radiation therapy uses high doses of radiation to kill or damage cancer cells. The two main types of radiation therapy for prostate cancer are external beam radiation therapy (“EBRT”) and brachytherapy (also known as “internal radiation”.)
We are not asking about radiopharmaceuticals here. Radiopharmaceuticals are radioactive medicines that are given through an IV infusion into your veins.
We are not asking about radiation to your pelvis for prostate cancer.
We are asking about radiation to your pelvis for cancer such as bladder cancer, rectal cancer, urethral cancer, pelvis bone cancer, or pelvic sarcomas.
This does not include radiopharmaceuticals to DIAGNOSE cancer.
Radiopharmaceuticals use radiation to target and kill cancer cells. They deliver radiation directly to the cancer cells, helping to kill them or reduce their growth.
Radiopharmaceuticals can be used to treat bone metastases from thyroid cancer, stomach cancer, and lung cancer.
Xofigo (radium-223) is a radiopharmaceutical used to treat men with castration-resistant prostate cancer that has spread to the bones. It is given as an injection into a vein, typically once a month for six months. Pluvicto (lutetium-177 PSMA) is another radiopharmaceutical for prostate cancer.
A radical prostatectomy is the most common type of surgery for prostate cancer. It is used to treat prostate cancer by removing the prostate gland and some surrounding tissue. It is typically done when the cancer is localized to the prostate and has not spread to other parts of the body.
Robot-assisted radical prostatectomy (RARP), such as the da Vinci Surgical System, is a type of radical prostatectomy that is becoming more common.
Transurethral resection of the prostate (TURP) is a procedure used to relieve urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH). TURP is a “non-invasive” treatment, meaning that no cuts are made in the skin. Using a resectoscope, the surgeon removes the inner portion of the prostate that is pressing against the urethra and is blocking the flow of urine.
Cryotherapy, also known as cryoablation or cryosurgery, is a treatment for prostate cancer that involves freezing and destroying cancerous tissue within the prostate. It is usually used for patients with localized prostate cancer (confined to the prostate), and can be an alternative to more invasive procedures like surgery or radiation therapy.
High-Intensity Focused Ultrasound (HIFU) uses ultrasound to target and destroy cancer cells within the prostate. It is a less invasive approach to treating prostate cancer than surgery, radiation, and chemotherapy.
This newer treatment can be the primary treatment for localized (non-metastatic) prostate cancer. A probe is inserted into the rectum and high-frequency sound waves are directed at the prostate gland, which heats up and destroys the cancerous tissue, while sparing the surrounding healthy tissue.
Orchiectomy (also known as surgical castration) is a surgical procedure used to treat prostate cancer that involves the removal of one or both testicles. Prostate cancer cells typically need testosterone to grow, and the testicles are the main place in the body that produces testosterone. Removing the testicles causes testosterone levels to drop dramatically, which often results in the cancer shrinking or growing more slowly.
Several types of hormone therapy are used to treat prostate cancer. The medicines listed here are known as androgen deprivation therapy (ADT.) Prostate cancer is fueled by male hormones such as testosterone. ADT lowers the level of male hormones in the body, which results in the cancer shrinking or growing more slowly. These drugs are usually given as injections.
If you are NOW taking any of these hormone medicines (ADT), please answer yes:
Hormone-resistant prostate cancer, also known as castration-resistant prostate cancer (CRPC) refers to prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels through treatment with androgen deprivation therapy (ADT) (hormones or orchiectomy.)
Over time, some prostate cancers adapt to growing in low androgen environments, becoming “castration-resistant.” CRPC is typically diagnosed when a patient on ADT begins to have rising PSA levels, suggesting that the cancer is growing despite low testosterone levels.
Androcur, Casodex, Erleada, Eulexin, Nilandron, Nubeqa, and Xtandi are androgen receptor inhibitors (anti-androgens). These drugs block the action of androgens (male hormones) such as testosterone. They are commonly used in treating advanced prostate cancer, especially where the cancer has become resistant to traditional hormone therapies. Androgen receptor inhibitors are often used with other therapies, such as androgen deprivation therapy and chemotherapy.
Nizoral, Orteronel, and Zytiga are androgen biosynthesis inhibitors that work by reducing the production of male hormones in the body. Zytiga is used mostly for metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC).
Galeterone is an oral androgen receptor signaling inhibitor that was developed for the treatment of castration-resistant prostate cancer (CRPC). CRPC is a type of prostate cancer that continues to progress despite low testosterone levels from androgen deprivation therapy (ADT).
Chemotherapy is a type of cancer treatment that uses drugs to kill or slow the growth or rapidly dividing cancer cells. Chemotherapy is typically used when prostate cancer has spread beyond the prostate gland and does not respond well to hormone therapy.
Taxotere (docetaxel) is one of the most commonly used chemotherapy drugs for prostate cancer. Jevtana (cabazitaxel) can be used in men who have already been treated with Taxotere.
Chemotherapy for prostate cancer is usually given intravenously (IV), which means that it is injected into a vein.
Prostate cancer is often managed with hormone therapies. However, chemotherapy can be an important part of treatment, especially when the cancer no longer responds to hormone therapy.
These chemotherapy drugs are used in the treatment of advanced or metastatic prostate cancer, particularly castration-resistant prostate cancer (CRPC). Taxotere is one of the most commonly used chemotherapy drugs for prostate cancer. Jevtana can be used in men who have already been treated with Taxotere.
These targeted therapies and immunotherapies are often used in combination with other treatments. They are meant for patients with specific genetic profiles or those who have not responded to more traditional therapies.
PARP inhibitors like Lynparza and Rubraca are targeted therapies that are FDA-approved and commonly used in the treatment of prostate cancer. They are used especially in situations that don’t respond to other treatments, such as castration-resistant prostate cancer (CRPC). Talzenna, Veliparib, and Zejula are PARP inhibitors that are not currently FDA-approved for prostate cancer.
Immunotherapies like Keytruda, Provenge, and Yervoy are used to increase the body’s immune response to prostate cancer, especially in patients with specific markers that make them more responsive to these medicines.
A heart attack, also known as a myocardial infarction, occurs when an artery that sends blood and oxygen to the heart is blocked. Fatty, cholesterol-containing deposits build up in the heart’s arteries over time, forming plaques. If a plaque ruptures, a blood clot can form. The clot can block arteries, causing a heart attack.
Symptoms of a heart attack include chest pain or discomfort; shortness of breath; and other symptoms including cold sweat, nausea, lightheadedness, and discomfort or pain in one or both arms, the back, neck, jaw, or stomach.
Answer “yes” if you have had a stroke or a transient ischemic attack (TIA) in the past 6 months. TIA is also called a “mini-stroke.”
A stroke, also known as a cerebrovascular accident (CVA) occurs when the blood supply to a part of the brain is interrupted or reduced, depriving brain tissue of oxygen and essential nutrients. Within minutes, brain cells begin to die. There are two main types of strokes—ischemic stroke, and hemorrhagic stroke. Ischemic stroke is the most common type of stroke.
Symptoms of a stroke can include trouble speaking or understanding speech; paralysis or numbness of the face, arm, or leg, often on one side of the body; vision problems in one or both eyes; sudden severe headache; and trouble walking, dizziness, or loss of balance.
A related condition is transient ischemic attack (TIA). It’s often called a “mini-stroke.” A TIA is a temporary period of stroke-like symptoms caused by a brief decrease in blood supply. The symptoms usually last for a few minutes to an hour and go away completely within 24 hours.
Angina is a type of chest pain or discomfort that occurs when the heart does not receive enough oxygen-rich blood. It is often described as a pressure, squeezing, burning, or tightness in the chest. Angina can also occur in the arms, neck, jaw, shoulder, or back. Stable angina occurs during physical activity or emotional stress, while unstable angina occurs at rest or with minimal physical activity and is more severe and unpredictable.
Arrhythmia is a condition where the heart beats too fast, too slow, or irregularly. Arrhythmias can be harmless or life-threatening, depending on the type and severity of the condition. Stable arrhythmias are those that do not pose an immediate threat to the patient's life. Unstable cardiac arrhythmia is a type of arrhythmia that is characterized by irregular, rapid, or slow heartbeats that can lead to sudden cardiac arrest or death if not treated promptly.
Heart failure is a chronic condition in which the heart is unable to pump enough blood to meet the body's needs. Asymptomatic heart failure means there are no noticeable symptoms. Symptomatic heart failure refers to heart failure that causes noticeable symptoms, such as shortness of breath, fatigue, and swelling in the legs and ankles. These symptoms occur when the heart is not pumping effectively, leading to a buildup of fluid in the body.
Here we are referring to very high blood pressure (hypertension). Answer “yes” if your blood pressure has recently been greater than 160/100. Either the first number has been greater than 160, or the second number has been greater than 100.
Blood pressure is measured using an inflatable cuff that is wrapped around your upper arm, above the elbow. The cuff is inflated quickly and air is then let out of the cuff. Blood pressure is recorded as two numbers: systolic over diastolic. If your blood pressure is 120/80 mmHg, it means your systolic pressure is 120 mmHg, and your diastolic pressure is 80 mmHg.
Some people with very high hypertension may experience headaches, vision problems, chest pain, irregular heartbeat, or difficulty breathing.
Magnetic Resonance Imaging (MRI) is an imaging machine that provides detailed images of soft tissues in the body. Certain conditions and situations can make MRI scans unsafe or impractical. These include:
Treating prostate cancer in individuals living with HIV or AIDS requires special care because of the interactions between HIV, cancer therapies, and the health of the patient. Individuals with HIV or AIDS often have weak immune systems, even when their illness is well-controlled on antiretroviral therapy (ART). A weak immune system makes a person more vulnerable to infections and complications. Because of this, individuals with HIV or AIDS may not be able to handle aggressive cancer treatments, such as chemotherapy, which can further weaken their immune system.
This question asks about how your illness may be affecting your general well-being and activities of daily life. It is called the ECOG (Eastern Cooperative Oncology Group) Performance Status tool.
The ECOG is particularly used with cancer patients. A person’s score ranges from “0” (fully active) to “5” (dead). The ECOG is very important for doctors to measure how well a patient can function, and to determine whether the patient can receive certain treatments, such as chemotherapy or surgery.
The ECOG is widely used in clinical trials and in oncology practices.
Some clinical trials have a life expectancy requirement, which is why we ask this question. Be sure to answer the question in months, not years.
With advances in diagnosis, treatment, and management, many men with prostate cancer are living longer than past statistics might suggest.
Anyone diagnosed with prostate cancer or seeking information about prognosis and life expectancy should discuss their individual case and circumstances with their oncologist.
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