Study on the Safety of Olaparib and Radium-223 for Men with Advanced Prostate Cancer with Bone Metastasis

Program Overview

This study is testing a combination of two treatments for men with advanced prostate cancer that has spread to the bones. Olaparib is a drug that blocks proteins called PARPs, which help repair DNA in cancer cells. By blocking these proteins, olaparib may stop cancer cells from fixing themselves, potentially slowing or stopping their growth. Radium-223 is a radioactive drug that targets cancer cells in the bones, delivering radiation directly to them while sparing normal cells. The study aims to find the best dose of olaparib when used with radium-223 and to evaluate how well this combination works in controlling cancer progression.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest dose of olaparib when combined with radium-223. In Phase II, they will evaluate how well this combination works in stopping cancer from progressing.

Participants will receive radium-223 through an IV once every 28 days for up to 6 cycles, as long as the cancer does not worsen and side effects are manageable. They will also take olaparib pills twice daily during each 28-day cycle. Throughout the study, participants will undergo scans and provide blood and tissue samples to monitor their response to treatment.

The study will also assess various outcomes, such as how long patients live without cancer progression, changes in prostate-specific antigen (PSA) levels, and overall survival. Researchers will explore the impact of treatment on quality of life and investigate genetic factors that may influence treatment response.

After completing the study treatment, participants will have follow-up visits every 6 months for 2 years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Locations