This study involves men with prostate cancer that has a specific change in genes called BRCA1 or BRCA2 mutation. The cancer is considered high-risk or very high-risk but is still located in the prostate area or nearby tissues, meaning it has not spread to distant parts of the body. The study uses several medications including Saruparib, which is also known by its code name AZD5305, along with Zytiga which contains abiraterone acetate. These treatments are given in addition to standard care that includes radiotherapy and androgen deprivation therapy, which is a treatment that lowers male hormones that can help prostate cancer grow. Some participants will receive placebo instead of the active study medication. Saruparib works as an inhibitor of PARP, which is a substance in cells, while abiraterone acetate is an androgen biosynthesis inhibitor that blocks the production of male hormones.
The purpose of the study is to find out if adding Saruparib to the standard treatment of radiotherapy and androgen deprivation therapy can help men with this type of prostate cancer live longer without the cancer spreading to distant parts of the body compared to placebo. The study will measure how long participants remain free of distant spread of cancer, which is called metastases-free survival, and will also look at overall survival and other measures of how well the treatment works. During the study, participants will receive the study medication in tablet form taken by mouth, and they will need to have various scans including computed tomography or magnetic resonance imaging, bone scans, and prostate-specific membrane antigen-positron emission tomography scans to check for any signs of cancer spread.
Participants will be randomly assigned to receive either the active study medication or placebo in addition to their standard treatment, and neither the participants nor their doctors will know which treatment they are receiving during the study. The study requires tissue samples from the prostate cancer to confirm the presence of the BRCA gene mutation before enrollment. Throughout the study, participants will be monitored for how the treatment affects their cancer, their overall health, and their quality of life through questionnaires about symptoms and daily functioning. Blood samples will also be collected to measure the levels of the study medication in the body and to understand how it works.
1Starting treatment after joining the study
After joining the study, you will be randomly assigned to receive either saruparib or a placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.
This assignment is done by chance, similar to flipping a coin. Neither you nor your doctor will know which treatment you are receiving during the study. This is called a double-blind design.
The study medication will be added to your standard treatment, which includes radiation therapy and androgen deprivation therapy. Androgen deprivation therapy is a hormone treatment that lowers male hormone levels in your body.
2Taking the study medication
You will take the study medication by mouth. The medication comes in the form of tablets.
If you are assigned to receive saruparib, you will take saruparib tablets. If you are assigned to the placebo group, you will take placebo tablets that look identical to the saruparib tablets.
The exact dosage, frequency, and duration of taking the tablets will be explained to you by the study staff based on the study protocol.
3Continuing hormone therapy
Throughout the study, you will continue receiving androgen deprivation therapy using a medication called a gonadotropin releasing hormone analogue. This medication helps lower testosterone levels in your body.
Some participants may also receive abiraterone acetate, which is another medication used to lower hormone levels. Abiraterone acetate is available as ZYTIGA in two strengths: 250 mg tablets or 500 mg film-coated tablets.
If prescribed, abiraterone acetate is taken by mouth according to the dosing schedule provided by your doctor.
4Undergoing imaging scans during the study
During the study, you will have regular imaging scans to monitor your condition. These scans help doctors see if there are any changes in your body.
The scans may include computed tomography (also called CT scan), magnetic resonance imaging (also called MRI), and bone scans. These are imaging tests that create pictures of the inside of your body.
You may also have a specialized scan called prostate-specific membrane antigen-positron emission tomography (also called PSMA-PET). This is a type of scan that can detect prostate cancer cells in your body.
These scans will be performed at specific time points throughout the study as outlined in the study schedule.
5Attending regular study visits
You will need to attend regular visits throughout the study. During these visits, the study staff will check your health and how you are responding to the treatment.
At these visits, blood samples may be collected to measure various markers, including prostate-specific antigen (also called PSA), which is a protein produced by prostate cells that can indicate disease activity.
Blood samples may also be taken to measure the levels of the study medication in your blood. This is called pharmacokinetic testing and helps understand how your body processes the medication.
Your overall health status will be assessed using the Eastern Cooperative Oncology Group performance status scale, which measures how the disease affects your daily living abilities.
6Completing quality of life questionnaires
During the study, you will be asked to complete questionnaires about your quality of life and symptoms.
These questionnaires include the EORTC-QLQ-C30, which asks about your general well-being and physical functioning, and the EORTC-QLQ-PR25, which asks specifically about urinary symptoms related to prostate conditions.
Your answers will help doctors understand how the treatment affects your daily life and symptoms.
7Following contraception requirements
Throughout the study and for 6 months after taking the last dose of study medication, you must use a condom during any sexual activity.
You must not father children or donate sperm from the time you join the study until 6 months after your last dose of study medication.
These measures are necessary to prevent potential risks to unborn children.
8Continuing study participation
The study will continue for an extended period to assess long-term outcomes. The estimated end date for the study is April 2036.
During this time, doctors will monitor for the appearance of distant metastases, which means cancer spreading to other parts of your body beyond the pelvis.
The study will also track other important outcomes, including overall survival, which means how long participants live, and prostate cancer-specific survival, which means survival specifically related to prostate cancer.
If your disease progresses and you require additional treatment, information about any new treatments you receive will be collected as part of the study follow-up.
Who Can Join the Study?
Requirements you must meet to participate in this study:
You must be male with a diagnosis of prostate adenocarcinoma, which is a type of cancer that starts in the prostate gland, confirmed by examining tissue under a microscope
You must have already received radiation therapy, which is a treatment that uses high-energy rays to destroy cancer cells, either as your first treatment or as a second treatment after surgery
Your radiation therapy must have been given with the goal of curing your cancer, not just controlling symptoms
You must have received or be receiving androgen deprivation therapy, which is a treatment that lowers male hormones that can help prostate cancer grow, using medications called GnRH analogues
You must have been diagnosed with high-risk or very high-risk prostate cancer that has not spread beyond the local area, or you must have experienced a return of cancer signs after prostate surgery
You must provide a sample of your tumor tissue that has been preserved in a special way for testing
Your tumor tissue must show a change in genes called BRCA1 or BRCA2 mutations, which are changes in genes that normally help prevent cancer
You must have imaging scans after completing radiation therapy, including a CT scan or MRI scan, which are tests that create detailed pictures of the inside of your body, and a bone scan, which checks for cancer in your bones
These scans must show either no signs of cancer or cancer only in the pelvic area, meaning the cancer has not spread to distant parts of your body
You must also have a special scan called a PSMA-PET scan after radiation therapy, which is a very sensitive test that looks for prostate cancer cells, and this scan must show no cancer or cancer only in the pelvic area
Your general health and ability to care for yourself must be good, rated as 0 or 1 on a scale called ECOG performance status, which measures how cancer affects your daily activities, and this must be stable for at least 2 weeks
Your doctors must expect that you will live at least 12 months
Your organs and blood cells must be working well enough according to specific laboratory test results
You must agree not to father children or donate sperm from the time you sign the consent form, during the entire study, and for 6 months after your last dose of study medication
You must agree to use a condom with spermicide during any sexual activity from the time you sign the consent form, during the study, and for 6 months after your last dose of study medication
Who Cannot Join the Study?
The study is only for male patients, so women cannot participate
Patients who do not have prostate cancer, which is a disease affecting the prostate gland in men, cannot participate
Patients whose prostate cancer is not classified as high-risk or very high-risk, meaning the cancer is less aggressive or less advanced, cannot participate
Patients who do not have a BRCA gene mutation, which is a specific change in genes that can be inherited and increases cancer risk, cannot participate
Patients whose prostate cancer is not localized or locally advanced, meaning the cancer has already spread far beyond the prostate area, cannot participate
Patients who are not suitable for radiation therapy, which is a treatment using high-energy rays to kill cancer cells, combined with androgen deprivation therapy, which is a treatment that lowers male hormones to slow cancer growth, cannot participate
Saruparib (AZD5305) is an experimental medication being tested in this trial. It is given in addition to standard radiation therapy and hormone therapy to see if it can help prevent prostate cancer from spreading to other parts of the body in patients who have a specific genetic change called a BRCA mutation.
Radiation therapy is a standard cancer treatment that uses high-energy rays to kill cancer cells in the prostate area. All participants in this study will receive this treatment.
Androgen deprivation therapy is a hormone treatment that lowers the levels of male hormones in the body or stops them from working. This helps slow the growth of prostate cancer cells. All participants in this study will receive this treatment.
Prostate Cancer – Prostate cancer is a disease that occurs when abnormal cells grow uncontrollably in the prostate gland, which is a small organ in men located below the bladder. The cancer can be confined to the prostate gland itself, which is called localised prostate cancer, or it can spread to nearby tissues, which is referred to as locally advanced prostate cancer. In some cases, the disease progresses and spreads to distant parts of the body, forming metastases in bones or other organs. High-risk and very high-risk prostate cancer refers to forms of the disease that have a greater likelihood of growing and spreading beyond the prostate. Some patients with prostate cancer carry mutations in genes such as the breast cancer gene, which can influence how the disease develops. The progression of prostate cancer can be monitored through imaging tests and measurements of specific markers in the blood.
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