133 Participants Needed

Olaparib + Radium-223 for Prostate Cancer

Recruiting at 26 trial locations
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: National Cancer Institute (NCI)
Must be taking: LHRH agonist/antagonist, Bisphosphonates, Denosumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/II trial studies the best dose and side effects of olaparib and how well it works with radium Ra 223 dichloride in treating patients with castration-resistant prostate cancer that has spread to the bone and other places in the body (metastatic). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Radioactive drugs, such as radium Ra 223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Giving olaparib and radium Ra 223 dichloride may help treat patients with castration-resistant prostate cancer.

Who Is on the Research Team?

Rana R. McKay, MD - Medical Oncology ...

Rana McKay, MD

Principal Investigator

Yale University Cancer Center LAO

Are You a Good Fit for This Trial?

Men with advanced prostate cancer that has spread to the bones and is resistant to castration can join this trial. They must have low testosterone levels, progressive disease, at least two bone metastases not previously treated with radiation, and be able to take oral medications. Men must agree to use contraception and avoid sperm donation during the study. Those with HIV are eligible if well-controlled.

Inclusion Criteria

Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate
Participants must have castrate levels of serum testosterone < 50 ng/dL
Participants without orchiectomy must be maintained on luteinizing hormone releasing hormone (LHRH) agonist/antagonist; participants receiving prior docetaxel abiraterone, or next generation AR antagonist (enzalutamide, apalutamide, or darolutamide) for hormone sensitive disease are permitted
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Exclusion Criteria

Patient unable to swallow orally administered medication
Deep venous thrombosis or pulmonary embolism within 3 months of study treatment
Prior treatment with radium-223
See 32 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Phase I Treatment

Patients receive radium Ra 223 dichloride IV and olaparib PO BID. Treatment repeats every 28 days for up to 6 cycles.

24 weeks
6 visits (in-person)

Phase II Treatment

Patients are randomized to receive radium Ra 223 dichloride and olaparib, with potential crossover for progression.

24 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

2 years
Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Olaparib
  • Radium Ra 223 Dichloride
Trial Overview The trial is testing different doses of Olaparib combined with Radium-223 in men whose prostate cancer has spread to their bones. Olaparib blocks proteins that repair tumor DNA, potentially stopping cancer growth; Radium-223 delivers radiation directly to tumor cells.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm II (radium Ra 223 dichloride)Experimental Treatment7 Interventions
Group II: Arm I (radium Ra 223 dichloride, olaparib)Experimental Treatment8 Interventions

Olaparib is already approved in European Union, United States for the following indications:

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Approved in European Union as Lynparza for:
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Approved in United States as Lynparza for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+
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