This phase 3 trial is examining the effectiveness and safety of niraparib (Zejula) in combination with abiraterone acetate (Zytiga) and prednisone (Deltasone) vs abiraterone acetate and prednisone plus placebo for patients with metastatic prostate cancer. The main outcome to be measured will be the survival time without cancer growing or spreading.
A treatment option for patients with metastatic (spread) prostate cancer (mPC) is with abiraterone acetate and prednisone. Abiraterone acetate works to block male sex hormones which help PC to grow. Prednisone is a steroid which decreases inflammation in the body.
It is not known if adding targeted therapies such as niraparib toabiraterone acetate and prednisone is more effective than abiraterone acetate and prednisone and a placebo (inactive drug).
This study is being done to investigate the use of niraparib in combination with abiraterone acetate and prednisone for patients with mPC. The main outcome to be measured will be the time until the disease progresses on imaging tests.
Who are they looking for?
1000 participants with mPC will be recruited. Patients must have metastases (tumors in other tissues than the prostate) confirmed by imaging tests. They should also have a testosterone level of 50 ng/dl or lower and a lower than 3 score on the pain scale.
Patients cannot participate if they have had previous treatment with a PARP inhibitor (a drug similar to niraparib) before, brain metastases, a history of acute myeloid leukemia or other cancers.
How will it work
There will be two groups. Group 1 will receive niraparib + abiraterone acetate-prednisone every day by tablet form. Group 2 will receive placebo + abiraterone acetate-prednisone every day by tablet form. They will be followed up in 73 months to measure the time spent without disease growing or spreading.