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INTREPId (INTermediate Risk Erection PreservatIon Trial)

NCT04025372 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2025-12-15

No results posted yet for this 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

Interventions

DRUG

Bicalutamide

Bicalutamide is categorized as an antiandrogen. Antiandrogens are substances that block the effects of testosterone. Cancer of the prostate depends on the male hormone testosterone for its growth. If the amount of testosterone is reduced it is possible to slow down or shrink the cancer.

DRUG

GnRH Agonist

In men, GnRH agonists cause the testicles to stop making testosterone. Some GnRH agonists are used to treat prostate cancer.

RADIATION

Radiation Therapy

Radiation Therapy is a cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors.

DRUG

Darolutamide

Darolutamide belongs to a class of drugs called androgen receptor inhibitors. In the body, these agents compete with androgens for binding to the androgen receptor, which reduces the ability of androgens to promote the growth of prostate cancer cells

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Decipher Biosciences

    collaborator UNKNOWN

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Martin T. King, MD, PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2027-10-01
Completion
2028-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04025372 on ClinicalTrials.gov