A Phase 2 Study of Radiation Therapy With or Without Relugolix in People With Prostate Cancer

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Full Title

The SUGAR Study: (SBRT and Ultrashort GnRH Antagonist-Relugolix) for Clinicogenomic Unfavorable Intermediate Risk Prostate Cancer

Purpose

Stereotactic body radiation therapy (SBRT) precisely delivers radiation to tumors during just a few treatment sessions. It is a standard treatment for prostate cancer that has not spread.

However, SBRT may not be enough for people with intermediate-risk prostate cancer and unfavorable genetic features. These features may make it more likely that the cancer will come back after radiation therapy. These people may benefit from SBRT with hormonal therapy early in their care.

In this study, researchers want to see if adding the hormonal therapy relugolix to SBRT is better than SBRT alone. The people in this study have intermediate-risk prostate cancer with unfavorable genetic features. Relugolix prevents the tumor from getting the hormones it needs to grow and is regularly used to treat more advanced prostate cancer.

If you join this study, you will be randomly assigned to have SBRT alone or with a short course of relugolix. Relugolix is taken orally (by mouth) for one month on this study.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have intermediate-risk prostate cancer with high-risk genetic features.
  • Not have had prior surgery or radiation therapy for prostate cancer.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. James Janopaul-Naylor’s office at 908-542-3429.

Protocol

24-294

Phase

Phase II (phase 2)

Co-Investigators

ClinicalTrials.gov ID

NCT06111781