RecruitingPhase 2NCT06111781

The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

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


Sponsor

Yale University

Enrollment

60 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (SUGAR Study) tests whether combining stereotactic body radiation therapy (SBRT — a highly precise form of radiation) with relugolix (an oral hormone-blocking drug) improves treatment outcomes for men with favorable intermediate-risk prostate cancer who have a high genomic risk score. **You may be eligible if...** - You are 18 or older (male or born male with a prostate, not on testosterone suppression) - You have confirmed adenocarcinoma of the prostate with Gleason score 3+4 (and PSA < 20) or Gleason 3+3 (and PSA 10–20) - Your Decipher Genomic Classifier score is 0.6 or higher (indicating high genomic risk) - Your prostate volume is 80 cc or less - Your testosterone and PSA are within required ranges **You may NOT be eligible if...** - You have had prior prostate surgery or radiation - You have confirmed metastatic disease - You have a history of long QT syndrome, significant heart rhythm abnormalities, or take QT-prolonging medications - You have ulcerative colitis or other inflammatory bowel disease - You are allergic to relugolix Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRelugolix 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.

RADIATIONSBRT standard of care radiotherapy treatment

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


Locations(4)

Yale Cancer Center

New Haven, Connecticut, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Washington

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06111781


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