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RECRUITING
NCT06111781
PHASE2

The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

Sponsor: Yale University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to measure the toxicity and effectiveness of the following treatments for cFIR/cgUIR prostate cancer patients. Stereotactic body radiotherapy (SBRT) alone or Stereotactic body radiotherapy (SBRT) combined with Ultrashort GNRH Antagonist called Relugolix (an oral drug). Treatments will be randomly assigned to study patients. The main questions it aims to answer are the following: 1. Whether the proportion of men who undergo SUGAR have a superior rate of attaining PSA nadir of \<= 0.2 compared to SBRT alone, and 2. Whether SUGAR is superior to historical rates of minimal clinically important decline (MCID) in sexual and hormonal function at 6 months for patients undergoing 6 months of androgen deprivation therapy (ADT) Men aged 18+ with cFIR/cgUIR will be enrolled. Specifically, patients must meet one of the following 2 criteria: 1) Gleason score must be Gleason 3+4 with a PSA \< 20 ng/mL, or 2) Gleason 6 (3+3) and PSA \> 10 ng/mL and \< 20 ng mL.

Official title: The SUGAR Study: (SBRT and Ultrashort GnRH Antagonist-Relugolix) for Clinicogenomic Unfavorable Intermediate Risk Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-04-15

Completion Date

2028-02

Last Updated

2026-01-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Relugolix 120 MG [Orgovyx]

ORGOVYX will be initiated with a loading dose of 360 mg on the first day and continue treatment with a 120 mg dose taken orally once daily at approximately the same time each day. Total length of treatment will be 30 days.

RADIATION

SBRT standard of care radiotherapy treatment

SBRT is a standard-of-care radiotherapy treatment for intermediate-risk prostate cancer.

Locations (3)

Yale Cancer Center

New Haven, Connecticut, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Washington

Seattle, Washington, United States