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A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
NCT04194554 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 261 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04194554 reports 6 study locations spanning 5 distinct geographic areas — top geographies include New York, Michigan, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04194554?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 261 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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