RecruitingPhase 2

The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

United States60 participantsStarted 2024-04-15

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
✓. Born assigned to Male gender, age 18 and above. Female identifying transgender or gender fluid are allowed on study provided they have not undergone testosterone suppressing therapy and were born with a prostate.
✓. Has a serum testosterone at the Screening visit of \>100 ng/dL
✓. Has a serum PSA concentration at the Screening visit of \> 0.2 ng/mL
✓. Able to swallow pills and take medication orally (no documented inability to eat solids and swallow pills) and be willing to adhere to the daily regimen of medication (if assigned to the experimental arm).
✓. For patients of reproductive potential: use of condoms or other methods (including abstinence) to ensure effective contraception with partner during radiotherapy and through 4 months after the last dose of the study drug or radiotherapy

Exclusion criteria

What they're measuring

Proportion of participants that attain PSA nadir

Timeframe: up to 2 years post treatment

Trial details

NCT IDNCT06111781

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02

Contact for this trial

Camalene Chrysostoum

860-714-4568 camalene.chrysostoum@yale.edu

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