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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: Active Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine the maximum tolerated dose (MTD) of olaparib in combination with radium Ra 223 dichloride (radium-223). (Phase I)
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 |
What the registry record for NCT03317392 still lists
NCT03317392 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 174-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (17% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Stage IVB Prostate Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03317392's enrollment target sits among peer trials
145 12th of 45 higher than 34 of 45 other Stage IVB Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IVB Prostate Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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