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The SUGAR Study; SBRT and Relugolix) for Prostate Cancer
Sponsor: Yale University
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
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.
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