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NCT03047135 · ClinicalTrials.gov registry record · Phase 2
Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis
A Phase 2 study of Prostate, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Active
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 4
- Study locations
NCT03047135: Active Phase 2 study of Prostate, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03047135 is a Phase 2 study of Prostate that is active but no longer recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 51 participants, below the 345-participant average among 5 other Prostate trials with a reported enrollment target (85% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03047135, a Phase 2 study of Prostate, is active but no longer recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 4
- Study locations
Study Summary
Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA response, and every patient with a radiographic response also had a PSA5 response. Ten of 11 responders had mutations in DNA repair genes. While PARP inhibition is showing promise in these initial studies, reserving its use for end-stage patients may not be the optimal timing for olaparib therapy in some patients. In addition, PARP enzymes function in roles beyond DNA repair, and specifically for prostate cancer are involved transcriptional regulation of the androgen receptor. PARP inhibition has not been tested in earlier disease states for prostate cancer.
Primary Outcome
Number of participants with PSA50 response defined as at least a 50% decline in Prostate Specific Antigen (PSA) from baseline value, confirmed with a second measurement at least 4 weeks apart.
Conditions Studied
Interventions
- DRUG Olaparib
Study Locations (4)
Pennsylvania
- Thomas Jefferson University - Philadelphia
- Allegheny Cancer Center - Pittsburgh
Maryland
- Johns Hopkins Hospital - Baltimore
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2026-05-01 |
| Phase | Phase 2 |
What the registry record for NCT03047135 still lists
NCT03047135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 345-participant average among 5 other Prostate trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Prostate appearing as the primary indexed condition, and to 1 intervention - of which Olaparib is the first listed.
NCT03047135 reports a single indexed study location in Pennsylvania, Maryland, Nebraska.
Frequently Asked Questions
What is clinical trial NCT03047135 about?
NCT03047135 is a clinical study titled "Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis". Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA response, and every patient with a radiographic response also had a PSA5 response. Ten of 11 responders had mutatio...
What is the current status of trial NCT03047135?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2017-03-01. Estimated completion is 2026-05-01.
What conditions does trial NCT03047135 study?
This clinical trial studies the following conditions: Prostate.
What interventions are being tested in trial NCT03047135?
The interventions under investigation include: Olaparib (DRUG).
Who is sponsoring clinical trial NCT03047135?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03047135 being conducted?
This trial has 4 study locations across Maryland, Nebraska, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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