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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 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.

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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.

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

FieldValue
Enrollment Target 234 participants
Start Date 2020-06-01
Est. Completion 2028-03-01
Phase Phase 2

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT04025372

The ClinicalTrials.gov registry entry for NCT04025372 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 234 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 (62% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 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 Darolutamide is the first listed.

NCT04025372 reports 11 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.