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PARP Inhibitor

Olaparib + Radium-223 for Prostate Cancer

Phase 1 & 2

Waitlist Available

Led By Rana R McKay

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to psa progression by prostate cancer working group (pcwg) 3 criteria, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing olaparib, a PARP inhibitor, as a possible treatment for metastatic castration-resistant prostate cancer. The trial will also study the best dose of olaparib and the side effects of the combination treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Olaparib may cause nausea, vomiting, fatigue, anemia (low red blood cell counts), or more serious side effects like lung inflammation or blood clots. Radium-223 can lead to similar issues plus bone marrow suppression which affects blood cell production.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to psa progression by prostate cancer working group (pcwg) 3 criteria, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to psa progression by prostate cancer working group (pcwg) 3 criteria, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to psa progression by prostate cancer working group (pcwg) 3 criteria, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radiographic progression-free survival (rPFS)

Secondary study objectives

ALP progression

Alkaline phosphatase (ALP) response

Incidence of adverse events

+6 more

Other study objectives

Change in levels of serum lactate dehydrogenase (LDH)

Frequency of mutations in the deoxyribonucleic acid (DNA) repair pathway

Homologous recombination deficiency

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (radium Ra 223 dichloride)Experimental Treatment7 Interventions

Patients receive radium Ra 223 dichloride as in Arm I. Patients with radiographic progression may crossover to Arm I. If patients have already completed all 6 infusions of radium, they will receive monotherapy with olaparib. If they have not yet completed all 6 radium-223 infusion, they will continue radium-223 infusion until completion and receive concurrent treatment with olaparib. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.

Group II: Arm I (radium Ra 223 dichloride, olaparib)Experimental Treatment8 Interventions

Patients receive radium Ra 223 dichloride IV over 1 minute on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radium Ra 223 Dichloride

2017

Completed Phase 2

~90

Biospecimen Collection

2004

Completed Phase 3

~2030