UM1 10096 Olaparib and Radium-223 in mCRPC with Bone Metastases - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if we can lower the chance of your prostate cancer growing or spreading by adding the study drug, Olaparib, with Radium-223 (the usual treatment).
Advanced Prostate Cancer
Who Can Participate in the Study?
Adult males who:
- Have prostate cancer that has grown after initial treatment and has spread to the bone
- Are willing to have a biopsy and agree to use two forms of contraception while on study and for 6 months after the study
- Are able to take oral medications
What is Involved?
If you choose to join this study, you will:
- Provide a tissue sample leftover from your biopsy if you have it
- Have a biopsy within 2 weeks before starting study drug
- Get the combination of radium-223 and olaparib
-- Radium-223 is given through your vein and will be given for up to 6 doses every 4 weeks
-- Olaparib will be in the form of pills given orally on a daily basis
- Have 1-2 blood tests every 28 days, plus one additional blood test at the end of the study
- Have a CT or MRI scan every 12 weeks
- Complete questionnaires to record your family history (at start of study only) and to record your function and pain level (every 12 weeks and at the end of study)