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Promising Results of PROpel Phase 3 Clinical Trial Announced

September 27, 2021
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Initial results of a large clinical trial in patients with advanced prostate cancer show promise for a combination treatment approach using two existing medications: olaparib plus abiraterone.

Patients with metastatic castration-resistant prostate cancer (mCRPC) have disease that has spread beyond the prostate and has progressed despite treatment with hormone therapy. Historically, such patients had few treatment options, but newer types of hormone therapy and, most recently, medications called PARP inhibitors, have improved outcomes. This study is evaluating olaparib (a PARP inhibitor) plus abiraterone, in patients with mCRPC as a “first-line” treatment, i.e., those who have not already received newer hormonal agents or chemotherapy.

The high-level results show that patients who received abiraterone plus olaparib had significantly longer time to “radiographic progression-free survival” (worsening of disease on scans or death), compared to patients who received the standard-of-care abiraterone with a placebo. This is a clinically meaningful and promising signal that combining these medications, earlier in the disease process, may prove more effective than abiraterone alone.

Olaparib is currently approved for use in patients with certain types of gene mutations, specifically, changes in genes that are involved in repairing damaged DNA. The PROpel trial includes patients with and without such gene changes. The results may eventually inform what we know about which patients are more likely to benefit from these medications.

The trial will continue to follow patients to measure overall survival and other outcomes. Data will be presented at an upcoming medical conference.