INTREPId (INTermediate Risk Erection PreservatIon Trial)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

234

Participants

Timeline

Start Date

June 1, 2020

Primary Completion Date

October 1, 2027

Study Completion Date

March 1, 2028

Conditions
Prostate Cancer
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

Trial Locations (11)

10016

NYU Langone Health, New York

11530

NYU Long Island, Garden City

13210

Associated Medical Professionals of NY, Syracuse

63108

Washington University School of Medicine in St. Louis, St Louis

68130

XCancer Omaha / Urology Cancer Center, Omaha

06904

Stamford Hospital, Stamford

02115

Beth Israel Deaconness Medical Center, Boston

Brigham and Women Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

01757

Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center, Milford

02190

Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital, South Weymouth

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

collaborator

Decipher Biosciences

UNKNOWN

lead

Dana-Farber Cancer Institute

OTHER