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Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer

NCT07216248 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-10-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.

Conditions

  • Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Interventions

DRUG

relugolix + ARPI

Step 1: Continuous treatment with relugolix + ARPI

DRUG

Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI

Intermittent treatment with relugolix + ARPI.

DRUG

relugolix or androgen deprivation therapy (ADT) + ARPI

Step 2: Standard-of-care, continuous treatment with relugolix or androgen deprivation therapy (ADT) + ARPI.

DRUG

relugolix + ARPI.

Step 2: Intermittent treatment with relugolix + ARPI.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2030-10-31
Completion
2031-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT07216248 on ClinicalTrials.gov