Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)
This research study is looking for men with prostate cancer that has spread to other parts of the body (metastatic) and is still responding to hormone therapy (hormone-sensitive). Participants will have recently finished treatment with either docetaxel chemotherapy or a special type of radiation therapy called Lu-PSMA, and their cancer hasn't worsened. The study aims to find out if adding a new drug called saruparib to their current hormone treatment is more effective than continuing with hormone treatment and a placebo (a dummy drug). This is to see if saruparib can help control the cancer for longer. It's a 'Phase 3' study, meaning it's a large trial testing if a new treatment is better than existing ones.
At a glance
What is this study about?
This clinical trial is designed for men who have prostate cancer that has spread to other parts of the body, known as 'metastatic hormone-sensitive prostate cancer' (mHSPC). 'Metastatic' means the cancer has spread, and 'hormone-sensitive' means it still responds to treatments that lower male hormones, like testosterone.
Participants in this study will have recently completed a course of treatment with either docetaxel chemotherapy or a specialised radiation therapy called Lu-PSMA. Importantly, their cancer must not have grown worse since these previous treatments. The main goal of the study is to compare two approaches: one group will receive a new drug called saruparib along with their usual hormone therapy, while the other group will receive a 'placebo' (a dummy drug with no active ingredients) alongside their usual hormone therapy. The researchers want to see if adding saruparib helps control the cancer more effectively and for a longer period.
Understanding if saruparib can improve outcomes for these patients is really important. If successful, it could offer a new treatment option for men in this situation. This is a Phase 3 study, which means it’s a big, carefully controlled trial comparing the new treatment against the best available standard care to see if it’s better and safe enough to be made available to more people.
Key takeaways
- This study is for men with advanced prostate cancer that is still responding to hormone therapy.
- Participants must have recently had docetaxel chemotherapy or Lu-PSMA radiation, with no cancer progression.
- It tests if a new drug, saruparib, combined with standard hormone therapy is more effective.
- You might receive saruparib or a placebo (dummy drug) plus your usual hormone treatment.
- Regular hospital visits, blood tests, and scans are part of participating.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To take part in this study, you must be at least 18 years old and have prostate cancer that has spread (metastatic) and is still sensitive to hormone treatment. You would have previously received docetaxel chemotherapy or Lu-PSMA radiation therapy for this type of prostate cancer, with your last dose within the last six months. Importantly, your cancer should not have progressed, and your Prostate-Specific Antigen (PSA) level needs to be 0.2 ng/mL or higher.
You must also already be receiving hormone therapy or have had surgery to remove your testicles. Any side effects from your previous docetaxel or Lu-PSMA treatment (except for hair loss or mild nerve problems) must have gone away or be very mild. You should also be in generally good health, with your body organs working properly, and doctors need to confirm certain genetic markers from a previous tumour sample and blood.
There are also some reasons why you might not be able to join. These include being allergic to saruparib or the other hormone drugs used in the study, having a history of serious low blood counts, or having a tendency to bleed easily. The study is specifically for men, including those assigned male at birth, who are capable of understanding and agreeing to take part.
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 18 years old or older?
- Do you have prostate cancer that has spread and is hormone-sensitive?
- Have you recently received docetaxel or Lu-PSMA treatment (in the last 6 months) and your cancer hasn't worsened?
- Is your PSA level 0.2 ng/mL or higher?
- Are you currently on hormone therapy or have you had related surgery?
- Are you able to provide a past tumour sample and a blood sample?
What does participation involve?
If you join this study, you will receive either the new drug saruparib or a placebo (a dummy pill) along with your current hormone treatment. You won't know which one you are receiving. You will have regular visits to the hospital or clinic for check-ups, blood tests, and scans to monitor your health and the cancer. The doctors will also check for any side effects from the medication. You'll take the study medication regularly as prescribed. The total time you spend in the study will vary, but it will involve ongoing assessments as long as the treatment is helping and you are tolerating it. There will also be a follow-up period after you stop taking the study medication to see how you are doing long-term.
Potential risks and benefits
Locations (210)
- Research SiteVerified postcodeHot Springs, United States· Not yet recruiting
- Research SiteVerified postcodeSpringdale, United States· Recruiting
- Research SiteVerified postcodeBeverly Hills, United States· Not yet recruiting
- Research SiteVerified postcodeLos Alamitos, United States· Not yet recruiting
- Research SiteVerified postcodeLos Angeles, United States· Not yet recruiting
- Research SiteVerified postcodeSan Diego, United States· Withdrawn
- Research SiteVerified postcodeMargate, United States· Recruiting
- Research SiteVerified postcodeMiami, United States· Recruiting
- Research SiteVerified postcodeOrlando, United States· Not yet recruiting
- Research SiteVerified postcodeHonolulu, United States· Not yet recruiting
- Research SiteVerified postcodeChicago, United States· Not yet recruiting
- Research SiteVerified postcodeChicago, United States· Not yet recruiting
Common questions
What is metastatic hormone-sensitive prostate cancer?
It's prostate cancer that has spread beyond the prostate gland to other parts of the body, but it still responds to treatments that lower male hormones.
What is saruparib?
Saruparib is a new drug being tested in this study. It aims to help control prostate cancer, and doctors want to see if it works well with standard hormone treatment.
What is a placebo?
A placebo is a 'dummy' drug that looks like the active drug but contains no medicine. It's used to fairly compare the new drug's effects.
Will I know if I'm getting saruparib or the placebo?
No, in this type of study (called 'double-blind'), neither you nor your doctors will know which treatment you are receiving until after the study is complete, unless there's a medical emergency.
What does 'PSA ≥ 0.2 ng/mL' mean?
This means your Prostate-Specific Antigen (PSA) blood test result must be 0.2 nanograms per millilitre or higher. PSA is a marker often used to monitor prostate cancer.
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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