Study on Androgen Deprivation Therapy (Relugolix) to Improve Imaging in High Risk Prostate Cancer Patients

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT07025369

Provider View

This clinical trial is exploring whether a short course of androgen deprivation therapy (ADT) using relugolix can enhance imaging techniques to better detect prostate cancer in patients with high or very high risk of the disease.

Patient Parameters

Program Overview

The purpose of this study is to see if a short course of androgen deprivation therapy (ADT) with the drug relugolix can improve the ability of a special imaging test, called PSMA PET/CT, to detect prostate cancer in patients at high risk. PSMA PET/CT is a standard imaging method for high-risk prostate cancer, but it sometimes struggles to find cancer that has spread to the lymph nodes. PSMA is a protein found in higher amounts on prostate cancer cells. Relugolix works by reducing testosterone levels, which may help increase PSMA levels and improve the detection of smaller cancer areas that were previously missed.

Description

PRIMARY OBJECTIVE:

  • Compare the imaging results of prostate cancer before and after using relugolix, focusing on a specific measurement called SUVmax and SUVmean.

SECONDARY OBJECTIVES:

  • Evaluate how well the imaging test detects cancer in the lymph nodes before and after using relugolix.
  • Compare the levels of PSMA in the lymph nodes before and after using relugolix.

STUDY DESIGN:

Participants are divided into three groups:

  • Group A: Participants receive an imaging test on day 0, take relugolix for 5 days, and have another imaging test on day 5. They will then have surgery within 90 days.
  • Group B: Participants receive an imaging test on day 0, take relugolix for 10 days, and have another imaging test on day 10. They will then have surgery within 90 days.
  • Group C: Participants receive an imaging test on day 0, take relugolix for 15 days, and have another imaging test on day 15. They will then have surgery within 90 days.

All participants will have blood samples collected throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older
  • Confirmed diagnosis of prostate cancer
  • Classified as high risk or very high risk prostate cancer
  • Testosterone level of 300 or higher
  • Good overall health with a performance status of 0, 1, or 2
  • Adequate blood counts and organ function
  • Male participants must agree to use condoms during sex and avoid donating semen during the study and for 30 days after the last dose of relugolix
  • Provide written informed consent

Exclusion Criteria

  • Recent chemotherapy or androgen deprivation therapy
  • Previous pelvic radiation
  • Severe health conditions that could interfere with the study
  • Active infections or heart problems
  • Participation in another investigational treatment
  • Other active cancers within the past year, except for certain skin cancers
  • Recent heart attack or severe heart failure
  • Use of certain medications that could interfere with the study

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Arizona85259ScottsdaleArizona

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