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ACTIVE NOT RECRUITING Phase 1

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

NCT03317392 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Biopsy Procedure
  • OTHER Laboratory Biomarker Analysis

Study Locations (20)

Missouri

  • Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters
  • Siteman Cancer Center at West County Hospital — Creve Coeur
  • University of Kansas Cancer Center - North — Kansas City
  • University of Kansas Cancer Center - Lee's Summit — Lee's Summit
  • University of Kansas Cancer Center at North Kansas City Hospital — North Kansas City
  • Washington University School of Medicine — St Louis
  • Siteman Cancer Center-South County — St Louis

Kansas

  • University of Kansas Clinical Research Center — Fairway
  • University of Kansas Cancer Center — Kansas City
  • University of Kansas Cancer Center-Overland Park — Overland Park
  • University of Kansas Hospital-Westwood Cancer Center — Westwood

California

  • UC San Diego Moores Cancer Center — La Jolla
  • University of California Davis Comprehensive Cancer Center — Sacramento

Connecticut

  • Smilow Cancer Center/Yale-New Haven Hospital — New Haven
  • Yale University — New Haven

Maryland

  • University of Maryland/Greenebaum Cancer Center — Baltimore

Michigan

  • Wayne State University/Karmanos Cancer Institute — Detroit

New Jersey

  • Rutgers Cancer Institute of New Jersey — New Brunswick

North Carolina

  • Duke University Medical Center — Durham

Trial Details

FieldValue
Enrollment Target 145 participants
Start Date 2019-02-04
Est. Completion 2027-02-16
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03317392

The ClinicalTrials.gov registry entry for NCT03317392 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03317392 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Missouri, Kansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03317392 about?

NCT03317392 is a clinical study titled "Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis". 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 m...

What is the current status of trial NCT03317392?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 145 participants. The study started on 2019-02-04. Estimated completion is 2027-02-16.

What conditions does trial NCT03317392 study?

This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03317392?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Laboratory Biomarker Analysis (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03317392?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03317392 being conducted?

This trial has 20 study locations across California, Connecticut, Kansas, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial