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NCT04025372 · ClinicalTrials.gov registry record · Phase 2
INTREPId (INTermediate Risk Erection PreservatIon Trial)
A Phase 2 study of Prostate Cancer, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 234
- Enrollment target
- 11
- Study locations
NCT04025372: Active Phase 2 study of Prostate Cancer, sponsored by Brigham and Women's Hospital.
NCT04025372 is a Phase 2 study of Prostate Cancer that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 234 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (62% lower). The trial reports 11 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04025372, a Phase 2 study of Prostate Cancer, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 234 participants
- Enrollment target
- 11
- Study locations
Study Summary
This research study is comparing the use of a new form of hormonal therapy used with radiation as a possible treatment for intermediate risk prostate cancer. More specifically, this research would help determine whether this new form of hormonal therapy is as effective as the standard hormone therapy while also preserving erectile function.
Primary Outcome
A response is defined as a PSA nadir \<= 0.5 within 6 months from end of treatment
Conditions Studied
Interventions
- DRUG Darolutamide
- RADIATION Radiation Therapy
- DRUG Bicalutamide
- DRUG GnRH Agonist
Study Locations (11)
Massachusetts
- Beth Israel Deaconness Medical Center - Boston
- Brigham and Women Hospital - Boston
- Dana Farber Cancer Institute - Boston
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center - Milford
- Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital - South Weymouth
New York
- NYU Long Island - Garden City
- NYU Langone Health - New York
- Associated Medical Professionals of NY - Syracuse
Connecticut
- Stamford Hospital - Stamford
Missouri
- Washington University School of Medicine in St. Louis - St Louis
Nebraska
- XCancer Omaha / Urology Cancer Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 2 |
What the registry record for NCT04025372 still lists
NCT04025372 is an interventional study that assigns participants to a tested intervention. The registered 234 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 (62% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Darolutamide is the first listed.
NCT04025372 lists 11 locations in 5 states (Massachusetts, New York, Connecticut).
Frequently Asked Questions
What is clinical trial NCT04025372 about?
NCT04025372 is a clinical study titled "INTREPId (INTermediate Risk Erection PreservatIon Trial)". This research study is comparing the use of a new form of hormonal therapy used with radiation as a possible treatment for intermediate risk prostate cancer. More specifically, this research would help determine whether this new form of hormonal therapy is as effective as the standard hormone therap...
What is the current status of trial NCT04025372?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 234 participants. The study started on 2020-06-01. Estimated completion is 2028-03-01.
What conditions does trial NCT04025372 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT04025372?
The interventions under investigation include: Darolutamide (DRUG), Radiation Therapy (RADIATION), Bicalutamide (DRUG), GnRH Agonist (DRUG).
Who is sponsoring clinical trial NCT04025372?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04025372 being conducted?
This trial has 11 study locations across Connecticut, Massachusetts, Missouri, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04025372's enrollment target sits among peer trials
234 197th of 735 higher than 539 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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