A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation
This study is investigating a new medication called Saruparib for men with high-risk prostate cancer, specifically those who have a change (mutation) in their BRCA gene. The main goal is to find out if adding Saruparib to usual treatments, like radiotherapy and hormone therapy, can stop the cancer from spreading to other parts of the body (known as metastases) for longer. Participants will either receive Saruparib or a dummy drug (placebo) alongside their regular treatment. Doctors hope this new drug could offer a better way to manage advanced prostate cancer for those with the BRCA gene change. An independent group of experts will monitor the study to make sure it's safe and effective.
At a glance
What is this study about?
This clinical trial is designed to investigate a new medication called Saruparib. It's for men with a specific type of prostate cancer: those with a high risk of their cancer growing or coming back, and who also have a mutation (a change) in their BRCA gene. You might have heard of BRCA genes because they're also linked to breast and ovarian cancer. In prostate cancer, a faulty BRCA gene can increase the risk of the cancer being more aggressive and spreading.
The study aims to see if adding Saruparib to the standard treatments – which usually include radiotherapy and hormone therapy (ADT) – can help prevent the cancer from spreading to other parts of the body. When cancer spreads, it's called developing metastases. Participants will be split into groups; some will receive Saruparib in addition to their standard care, and others will receive a placebo (a dummy drug with no active ingredients) alongside their standard care. This allows researchers to compare the effects of Saruparib versus no additional treatment fairly.
The main thing doctors want to measure is how long men can live without their cancer spreading. They will also be closely watching for any side effects and making sure the treatment is safe. The trial involves a large number of participants to ensure the results are reliable. An independent committee of medical experts will regularly review the study's progress to confirm it’s being conducted safely and to assess how well Saruparib is working.
Key takeaways
- Investigating Saruparib for high-risk prostate cancer with a BRCA gene mutation.
- Aims to prevent cancer spreading to other parts of the body.
- Compares Saruparib + standard care against placebo + standard care.
- Participants will have regular check-ups and follow-up.
- Eligibility requires a confirmed BRCA gene mutation identified from a tumour sample.
- Study continues until cancer spread or end of study for all participants.
Who may be eligible?
This study is looking for men who have been diagnosed with prostate cancer. To be eligible, your prostate cancer needs to be considered high-risk or very high-risk, meaning it's more likely to grow or spread, or it has come back after previous treatment. A really important factor for this study is that you must have a confirmed change (mutation) in your BRCA1 or BRCA2 gene, which will be checked from a sample of your tumour tissue.
You should have already received radiotherapy as part of your treatment. Your doctors will need to confirm that scans, like CT, MRI, and a specialised PSMA-PET scan, show no signs of the cancer having spread to other parts of your body. You also need to be fit enough for the study, usually meaning you can carry out most of your normal daily activities, and your key organs (like your liver and kidneys) are working well.
Finally, you'll need to be receiving continuous hormone therapy (ADT). The study is for men aged 18 and over, with no upper age limit, and you should be expected to live for at least another 12 months. Men who cannot father children or donate sperm during the study and for 6 months afterwards will also be included.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a man diagnosed with high-risk or very high-risk prostate cancer?
- Has a specific BRCA1 or BRCA2 gene change been found in your cancer cells?
- Have you already received radiotherapy for your prostate cancer?
- Are scans (like CT, MRI, PSMA-PET) showing no signs of cancer spread?
- Are you currently receiving continuous hormone therapy (ADT)?
What does participation involve?
If you join this study, you'll be randomly assigned to one of two groups: one receiving the new drug Saruparib, and the other receiving a placebo (a dummy drug). Both groups will also continue to receive their standard treatments, which include hormone therapy (ADT) and, for some, an additional drug called abiraterone, along with prednisolone/prednisone. You won't know whether you're getting Saruparib or the placebo.
You will have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. The study is designed to follow participants until the very end, which could be several years, to completely understand the long-term effects of Saruparib. The total duration of your active participation, including how often you receive the study drug and attend appointments, will be clearly explained by the study team, but the follow-up will continue for a long time to assess your survival.
Potential risks and benefits
Locations (329)
- Research SiteVerified postcodePhoenix, United States· Recruiting
- Research SiteVerified postcodeTucson, United States· Not yet recruiting
- Research SiteVerified postcodeLa Jolla, United States· Recruiting
- Research SiteVerified postcodeLa Jolla, United States· Recruiting
- Research SiteVerified postcodeLos Angeles, United States· Recruiting
- Research SiteVerified postcodeSan Diego, United States· Recruiting
- Research SiteVerified postcodeSan Luis Obispo, United States· Recruiting
- Research SiteVerified postcodeLakewood, United States· Recruiting
- Research SiteVerified postcodeHialeah, United States· Recruiting
- Research SiteVerified postcodeJacksonville, United States· Recruiting
- Research SiteVerified postcodeTampa, United States· Recruiting
- Research SiteVerified postcodeNewnan, United States· Recruiting
Common questions
What is a BRCA mutation?
A BRCA mutation is a change in a specific gene that usually helps repair damaged DNA. When it's faulty, it can increase the risk of certain cancers, including prostate cancer.
What is 'standard RT/ADT'?
This refers to standard treatment for prostate cancer, which includes Radiotherapy (RT) to target and destroy cancer cells, and Androgen Deprivation Therapy (ADT), which is hormone therapy to reduce male hormones that can fuel prostate cancer growth.
What does 'metastases-free survival' mean?
This is how long a person lives without their cancer spreading from the original site to other parts of the body. It's a key measure in this study.
Will I know if I'm getting the real drug or a placebo?
No, in this type of study (called 'blinded'), neither you nor your doctors will know if you're receiving Saruparib or the placebo. This helps ensure fair and unbiased results.
Can I leave the study if I change my mind?
Yes, absolutely. You are free to withdraw from the study at any point, and your decision will not affect the medical care you receive.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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