Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis

Part of paid clinical trials in La Jolla, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03317392
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Castration-Resistant Prostate Carcinoma
  • Metastatic Prostate Adenocarcinoma
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Olaparib — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Radium Ra 223 Dichloride — RADIATION
    Given IV

Study Details

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.

Key Dates

Start date
Feb 4, 2019
Status verified
Feb 2026
Primary completion
Mar 31, 2025
Completion
Feb 16, 2027

Study Design

Enrollment
132 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I (radium Ra 223 dichloride, olaparib)
    Patients in Phase I 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.
  • Experimental: Phase II Arm I (radium Ra 223 dichloride, olaparib)
    Patients in Phase II Arm I 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.
  • Experimental: Phase II Arm II (radium Ra 223 dichloride)
    Patients in Phase 2 Arm II 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.

Primary Outcome Measure

Phase I: Maximum Tolerated Dose [ Time Frame: 56 days ]

Locations (22)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
University of Kansas Clinical Research CenterFairwayKansas66205-
University of Kansas Cancer CenterKansas CityKansas66160-
University of Kansas Cancer Center-Overland ParkOverland ParkKansas66210-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-
University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas CityMissouri64116-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Duke University Medical CenterDurhamNorth Carolina27710-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

Find similar trials in La Jolla, CA

By research site
UC San Diego Moores Cancer Center· La Jolla, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CASmilow Cancer Center/Yale-New Haven Hospital· New Haven, CTYale University· New Haven, CTUniversity of Kansas Clinical Research Center· Fairway, KSUniversity of Kansas Cancer Center· Kansas City, KS

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