Study on Relugolix and Radiation Therapy for High Risk Prostate Cancer

Sponsor: University of Kansas Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06129851

Provider View

This clinical trial is exploring the best duration for using the drug relugolix alongside radiation therapy to treat patients with high risk prostate cancer. Relugolix helps lower testosterone levels, which can slow the growth of prostate cancer. The study aims to find out if this combination is more effective and has fewer side effects than previous treatments.

Patient Parameters

Program Overview

This study is testing how long relugolix should be used with radiation therapy to treat high risk prostate cancer. Prostate cancer grows with the help of testosterone, a hormone in the body. Relugolix is a medication that reduces testosterone levels, potentially slowing cancer growth. It is already approved for treating prostate cancer. The study will see if adding relugolix to radiation therapy works better and has fewer side effects than older hormone treatments, and aims to find the best duration for using relugolix with radiation.

Description

The main goal of this study is to compare how well prostate cancer is controlled when relugolix is used for either 12 months or 24 months, along with radiation therapy. Researchers will look at how often the cancer returns, the quality of life of patients, any side effects, and how the treatment affects heart health. They will also check how well patients stick to taking their medication and how quickly testosterone levels return to normal after stopping relugolix.

Patients will be randomly assigned to one of two groups:

  • Group A: Patients will take relugolix by mouth every day for 12 months. They will also receive radiation therapy starting 30 to 180 days after beginning relugolix. This includes brachytherapy and external beam radiation over 25 sessions. Patients will have scans and may give blood samples during the study.

  • Group B: Patients will take relugolix by mouth every day for 24 months. They will also receive the same radiation therapy as Group A. Patients will have scans and may give blood samples during the study.

After finishing the treatment, patients in Group A will have follow-up visits every 3 months for the first year, then every 6 months for up to 3 years. Patients in Group B will have follow-up visits every 6 months for up to 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand the study and agree to participate.
  • Must be 18 years or older.
  • Must be in good general health with a performance status of 0 or 1.
  • Must have a life expectancy of more than 5 years.
  • Must have high risk or very high risk prostate cancer as defined by specific medical criteria.
  • Must be eligible for treatment with brachytherapy, external beam radiation, and hormone therapy.
  • Must have adequate blood cell counts and liver function.
  • Men with partners who can become pregnant must agree to use effective birth control during the study and for 2 weeks after finishing relugolix.

Exclusion Criteria

  • Cannot be enrolled in another treatment study at the same time.
  • Cannot use other cancer treatments or experimental drugs during the study.
  • Cannot have a psychiatric condition or social situation that would prevent following the study requirements.
  • Cannot have an allergy to any ingredient in the study drug.
  • Cannot have a serious infection within 2 weeks before starting the study.
  • Cannot be on current hormone therapy unless testosterone levels are above 50 ng/dL.
  • Cannot have a prolonged QT interval on an ECG.
  • Cannot have had previous pelvic radiation that would overlap with the study treatment.
  • Cannot have had prostate surgery.

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