OncoMatch/Clinical Trials/NCT06111781
The SUGAR Study; SBRT and Relugolix) for Prostate Cancer
Is NCT06111781 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Relugolix 120 MG [Orgovyx] for prostate cancer.
Treatment: Relugolix 120 MG [Orgovyx] — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Grade: gleason 3+4, gleason 6 (3+3) (gleason)
Demographics
Prior therapy
Cannot have received: GNRH antagonist therapy
GNRH antagonist therapy ... are medically contraindicated or not tolerated
Cannot have received: SBRT to the prostate
SBRT to the prostate are medically contraindicated or not tolerated
Cannot have received: surgical castration
History of surgical castration
Cannot have received: surgery or prostate directed radiotherapy for prostate cancer
Prior treatment for prostate cancer with surgery or prostate directed radiotherapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale Cancer Center · New Haven, Connecticut
- Memorial Sloan Kettering Cancer Center · New York, New York
- University of Washington · Seattle, Washington
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06111781 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages