The SUGAR Study: Using SBRT and Relugolix for Treating Certain Types of Intermediate Risk Prostate Cancer

Sponsor: Yale University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06111781

Provider View

This clinical trial is exploring the safety and effectiveness of two treatment options for men with specific types of intermediate risk prostate cancer. The study compares stereotactic body radiotherapy (SBRT) alone to SBRT combined with a short course of the oral drug Relugolix.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of two treatment approaches for men with certain types of intermediate risk prostate cancer. Participants will receive either stereotactic body radiotherapy (SBRT) alone or SBRT combined with a short course of the oral medication Relugolix. The study aims to determine if the combination treatment helps achieve lower PSA levels and if it affects sexual and hormonal function compared to historical data. Men aged 18 and older with specific prostate cancer characteristics are eligible to participate.

Description

Unfavorable Intermediate Risk (UIR) Prostate Cancer is a type of prostate cancer that is localized and can be cured but may need more treatment than standard radiation alone. Some prostate cancers, classified as favorable intermediate risk based on clinical factors, may behave more aggressively if they have a high-risk gene expression score. This presents a challenge in deciding the best treatment approach.

Recent studies suggest that androgen deprivation therapy (ADT) can be beneficial for intermediate risk prostate cancer, but it can cause side effects like hot flashes, fatigue, and sexual dysfunction. To balance the benefits and side effects, this study is testing a shorter course of ADT using the oral medication Relugolix, which is given alongside radiation treatment. The study will compare the outcomes of SBRT alone versus SBRT combined with Relugolix (SUGAR) in patients with clinicogenomic unfavorable intermediate risk prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed and dated consent to participate.
  • Willing to follow all study procedures and be available for the study duration.
  • Diagnosed with prostate adenocarcinoma.
  • Born male, aged 18 or older. Transgender or gender fluid individuals are eligible if they have not had testosterone suppressing therapy and were born with a prostate.
  • Testosterone level over 150 ng/dL at screening.
  • PSA level over 0.2 ng/mL at screening.
  • Able to swallow pills and willing to take medication as prescribed if assigned to the experimental group.
  • Use effective contraception during and after treatment if of reproductive potential.
  • Have clinical favorable intermediate risk prostate cancer with specific Gleason scores and PSA levels.
  • High genomic risk score from recent biopsy.
  • Prostate volume of 80 cc or less as measured by MRI or ultrasound.

Exclusion Criteria

  • Currently using medications that prolong QT interval.
  • Allergic to Relugolix.
  • Received other investigational drugs or treatments for prostate cancer within 30 days before joining the study.
  • History of inflammatory bowel disease like ulcerative colitis.
  • Have connective tissue diseases such as lupus or scleroderma.
  • Cannot medically tolerate GNRH antagonist therapy or SBRT.
  • History of long QT syndrome or certain ECG abnormalities.
  • History of surgical castration.
  • Previous prostate cancer treatment with surgery or radiation.

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