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NCT04194554 · ClinicalTrials.gov registry record · Phase 1
A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
A Phase 1 study of Prostate Cancer, sponsored by University of Michigan Rogel Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
- 6
- Study locations
NCT04194554 is a Phase 1 study of Prostate Cancer that is active but no longer recruiting, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 102 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (83% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT04194554, a Phase 1 study of Prostate Cancer, is active but no longer recruiting, sponsored by University of Michigan Rogel Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (the phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (the phase 2 portion of the study).
Conditions Studied
Interventions
- DRUG Abiraterone Acetate
- DRUG Niraparib
- DRUG Leuprolide
- RADIATION Stereotactic body radiotherapy (SBRT)
Study Locations (6)
New York
- Cornell University - New York
- Weill Cornell Medicine - New York
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
Ohio
- University Hospitals Seidman Cancer Center - Cleveland
Texas
- University of Texas Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2020-11-06 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04194554
The ClinicalTrials.gov registry entry for NCT04194554 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (83% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Abiraterone Acetate is the first listed.
NCT04194554 reports 6 study locations spanning 5 distinct geographic areas - top geographies include New York, Michigan, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04194554 about?
NCT04194554 is a clinical study titled "A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer". The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (the phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this trea...
What is the current status of trial NCT04194554?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2020-11-06. Estimated completion is 2027-05.
What conditions does trial NCT04194554 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT04194554?
The interventions under investigation include: Abiraterone Acetate (DRUG), Niraparib (DRUG), Leuprolide (DRUG), Stereotactic body radiotherapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT04194554?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04194554 being conducted?
This trial has 6 study locations across Michigan, Minnesota, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.