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The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

NCT06111781 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-11

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • James Yu · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT06111781 on ClinicalTrials.gov