Duke logo

ETCTN 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).

What is the Condition Being Studied?

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

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

- Provide a tissue sample leftover from your biopsy if you have it
OR
- 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)

Study Details

Full Title
A Phase 1/2 Study of Combination Olaparib and Radium-223 in Men with Metastatic Castration-Resistant Prostate Cancer with Bone Metastases (COMRADE) (10096)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00101127
NCT:NCT03317392
Phase
Phase I/II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698