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NCT03516812 · ClinicalTrials.gov registry record · Phase 2
Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT03516812: Completed Phase 2 study, sponsored by University of Washington.
NCT03516812 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03516812, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This phase II trial studies how well testosterone (enanthate or cypionate) and olaparib work in treating patients with prostate cancer that has progressed despite hormonal therapy. Hormonal therapy, such as leuprolide, may lessen the amount of male sex hormones made by the body. In patients that have developed progressive cancer in spite of standard hormonal treatment (i.e. castration-resistant prostate cancer), administering testosterone may result in regression of tumors by causing DNA damage in cancer cells that have adapted to low testosterone conditions. Olaparib may stop the growth of tumor cells by blocking some of the enzymes involved in repairing DNA damage. Therefore, giving testosterone and olaparib together may work better in treating castration-resistant prostate cancer by generating DNA damage that the cancer cell is unable to repair.
Primary Outcome
PSA response will be defined as a decline in PSA ≥ 50% compared to baseline in patients who received at least 12 weeks of treatment. Will be calculated as the percentage with 95% confidence interval (CI) of the total number of subjects that achieved a PSA response.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- OTHER Survey Administration
- DRUG Olaparib
- DRUG Testosterone Enanthate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-08-29 |
| Est. Completion | 2024-04-12 |
| Phase | Phase 2 |
What the finished NCT03516812 record still lists
NCT03516812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03516812 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03516812 about?
NCT03516812 is a clinical study titled "Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer". This phase II trial studies how well testosterone (enanthate or cypionate) and olaparib work in treating patients with prostate cancer that has progressed despite hormonal therapy. Hormonal therapy, such as leuprolide, may lessen the amount of male sex hormones made by the body. In patients that hav...
What is the current status of trial NCT03516812?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2018-08-29. Estimated completion is 2024-04-12.
What interventions are being tested in trial NCT03516812?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Survey Administration (OTHER), Olaparib (DRUG), Testosterone Enanthate (DRUG).
Who is sponsoring clinical trial NCT03516812?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03516812's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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