The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06111781
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Relugolix 120 MG [Orgovyx] — DRUG
    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 — RADIATION
    SBRT is a standard-of-care radiotherapy treatment for intermediate-risk prostate cancer.

Study Details

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.

Key Dates

Start date
Apr 15, 2024
Status verified
May 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Stereotactic body radiotherapy
    SBRT Though a range of doses are delivered nationally for IR prostate cancer, the most common regimen is 7.25 Gy- 8.00 Gy x 5 fractions, given over 2 weeks.
  • Active Comparator: Relugolix and SBRT
    SBRT and Relugolix SBRT along with 30 days of total relugolix (study drug) will be used. Relugolix starting 14 days to 17 days prior to the first treatment.

Primary Outcome Measure

Proportion of participants that attain PSA nadir [ Time Frame: up to 2 years post treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06520
Amanda Davis
[email protected]
4753217899
Yi An, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10017
Luz Tovar-Schultz
[email protected]
James Robert Janopaul-Naylor, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98109
Ting Martin Ma, MD
[email protected]
206-606-7318
Nazleen Patel-Ejarque, MPH
[email protected]
206-616-3916
Ting Martin Ma, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Yale Cancer Center· New Haven, CTMemorial Sloan Kettering Cancer Center· New York, NYUniversity of Washington· Seattle, WA

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