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NCT03317392 · ClinicalTrials.gov registry record · Phase 1
Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis
A Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 145
- Enrollment target
- 20
- Study locations
NCT03317392 is a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 145 participants, below the 174-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT03317392, a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 145 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2019-02-04 |
| Est. Completion | 2027-02-16 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 174-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (17% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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.
NCT03317392 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Missouri, Kansas, California.
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.
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).
Who is sponsoring clinical trial NCT03317392?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
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Stage IVB Prostate Cancer AJCC v8
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Castration-Resistant Prostate Carcinoma
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California
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