Active not recruitingPHASE3INTERVENTIONAL

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

This study, called PROpel, is testing a new way to treat advanced prostate cancer that has spread and is no longer responding to standard hormone therapy. It's for men who haven't yet received chemotherapy or other new hormone-blocking drugs for their advanced cancer. The main goal is to see if combining two drugs, olaparib and abiraterone, works better than abiraterone by itself, and if it's safe. Abiraterone is already a common treatment, but researchers want to know if adding olaparib can improve outcomes. Patients involved in the study will be split into two groups by chance: one group will get the combination of olaparib and abiraterone, and the other will get a dummy pill (placebo) with abiraterone. Both groups will also receive a steroid medicine. This study aims to find more effective treatments for metastatic castration-resistant prostate cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

895

Start

31 Oct 2018

Estimated completion

05 Feb 2027

Metastatic Castration-resistant Prostate Cancer

Results

Results from this study

Posted June 2023

Results have been published for this study.

Primary outcome

Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment

An rPFS event is defined as progression determined by Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\] and/or Prostate Cancer Working Group 3 \[PCWG-3\] or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy prior to progression. Per RECIST v1.1, progression is defined as the sum of TLs has a 20% and absolute ≥ 5mm increase from nadir, and/or unequivocal progression in any non target lesions, and/or any new lesion identified. Per PCWG3, progression on a bone scan is defined as 2 or more new lesions observed from the first visit after baseline compared to baseline, or from all other visits compared to first visit after baseline. A confirmatory scan is required.

Full results on the registry

What is this study about?

This study is about finding better ways to treat a specific type of prostate cancer called metastatic castration-resistant prostate cancer, often shortened to mCRPC. 'Metastatic' means the cancer has spread to other parts of the body, and 'castration-resistant' means it's no longer responding to treatments that lower testosterone. This is a common and serious stage of prostate cancer, so finding new and effective treatments is very important.

The researchers want to see if combining two drugs, olaparib and abiraterone, is more effective and safe than just using abiraterone alone. Abiraterone is a medication already used to treat mCRPC, but olaparib is a newer drug being explored. This study is for men who haven't yet had chemotherapy or other strong hormone treatments for their advanced prostate cancer. The aim is to fight the cancer more effectively by using these drugs together earlier in the treatment journey.

Participants in the study will be randomly assigned to one of two groups. One group will receive olaparib along with abiraterone, and the other group will receive a 'placebo' (a dummy pill that looks like olaparib but has no active drug) along with abiraterone. Both groups will also take a steroid medicine like prednisone or prednisolone. By comparing the results from these two groups, doctors can understand if adding olaparib makes a real difference in how well the treatment works and what side effects might occur.

Key takeaways

This study evaluates a new combination for advanced prostate cancer.
It compares olaparib + abiraterone with abiraterone + placebo.
It's for men who haven't had prior chemo for advanced prostate cancer.
Participants will be assigned treatments by chance (randomly).
Both treatment effectiveness and side effects will be carefully monitored.
It aims to find better first-line treatment options for mCRPC.

Who may be eligible?

To join this study, you need to be a man aged 18 or older with prostate cancer that has spread (metastatic) and is no longer responding to standard hormone therapy (castration-resistant). You must not have had chemotherapy or other new types of hormone-blocking drugs for your advanced prostate cancer previously.

Your prostate cancer must have been confirmed by a biopsy, and there must be clear signs that it has spread, visible on scans. You also need to be currently receiving treatment to lower your testosterone levels, and these levels must be very low. Importantly, you should be considered suitable for abiraterone treatment and show signs that your disease is getting worse.

Before taking part, your body's main organs and bone marrow need to be working normally, as confirmed by various tests. You must also be able to understand the study and its requirements, and give your written permission to participate.

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.

Am I a man aged 18 or older?
Do I have prostate cancer that has spread (metastatic)?
Is my prostate cancer no longer responding to hormone-lowering treatments (castration-resistant)?
Have I NOT had chemotherapy or new strong hormone drugs for my advanced prostate cancer yet?
Am I currently on treatment to lower my testosterone levels?
Do my doctor and I feel I'm generally healthy enough for a new treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups. One group will receive olaparib tablets twice a day, plus abiraterone tablets once a day. The other group will receive an inactive dummy pill (placebo) twice a day, plus abiraterone once a day. Both groups will also take a steroid medication (prednisone or prednisolone) twice a day.

You would take these medications regularly. Throughout the study, you'll have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. Doctors will also keep a close eye on any side effects you might experience. The total duration of your participation would involve continued treatment for as long as it benefits you and you tolerate it, followed by regular follow-up appointments.

Potential risks and benefits

Taking part in this study could offer you access to a new combination treatment for your prostate cancer that might be more effective than existing options. However, as with any medication, there's a chance of side effects. Olaparib, abiraterone, and the steroid medication all have known side effects, which doctors will discuss with you. These could range from mild to serious and will be monitored closely. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your future medical care. Your safety and well-being are always the top priority.

Locations (132)

Research Site
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Birmingham, United States
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Anchorage, United States
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Tucson, United States
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Tucson, United States
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Clovis, United States
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Los Angeles, United States
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Los Angeles, United States
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Sacramento, United States
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San Diego, United States
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Denver, United States
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Lisle, United States
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Jeffersonville, United States

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This means your prostate cancer has spread to other parts of your body (metastatic) and is no longer responding to treatments that lower testosterone (castration-resistant).

What are olaparib and abiraterone?

Abiraterone is a well-known hormone treatment for prostate cancer. Olaparib is a newer drug being tested to see if it can improve treatment when used alongside abiraterone.

Will I know which treatment I'm getting?

No, you will be randomly assigned to either the combined olaparib and abiraterone, or a dummy pill and abiraterone. This is to ensure the study results are fair and unbiased.

What if I've already had chemotherapy for my prostate cancer?

This study is specifically for men who have not yet had chemotherapy or certain other strong hormone treatments for their advanced prostate cancer at this stage.

How long will I be in the study?

You would continue treatment for as long as it helps you and you tolerate it. There would then be regular follow-up appointments to check on your health.