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Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

NCT06463457 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-03-09

No results posted yet for this study

Summary

This research study is being done to determine the rate of testosterone recovery after completing two years of treatment with the combination of relugolix and darolutamide as well as to assess the safety of the drugs when administered in combination.

The names of the drugs in this study are:

* Relugolix (a type of gonadotropin-releasing hormone receptor antagonist)
* Darolutamide (a type of androgen receptor antagonist)

Conditions

Interventions

DRUG

Darolutamide

Androgen receptor antagonist, tablet taken orally per protocol.

DRUG

Relugolix

Gonadotropin-releasing hormone (GnRH) receptor antagonist, tablet taken orally per protocol.

Sponsors & Collaborators

Principal Investigators

  • Atish Choudhury, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-13
Primary Completion
2028-11-30
Completion
2028-11-30
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 NCT06463457 on ClinicalTrials.gov