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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: Active Phase 1 study of Prostate Cancer, sponsored by University of Michigan Rogel Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The proportion of patients at each dose level with dose-limiting toxicity (DLT), defined as any treatment related grade 3-5 adverse event experienced within the first 4 treatment cycles (112 days), assessed per NCI's CTCAE version 5.0.
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 |
What the registry record for NCT04194554 still lists
NCT04194554 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (83% lower).
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 lists 6 locations in 5 states (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.
Learn More About Clinical Trials
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Where NCT04194554's enrollment target sits among peer trials
102 328th of 735 higher than 407 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
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