Study Comparing Relugolix and Leuprolide for Quality of Life in Prostate Cancer Patients

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05765500

Provider View

This clinical trial is examining how two approved treatments for prostate cancer, Relugolix and Leuprolide, affect patients' quality of life, blood levels, cholesterol, and blood sugar. Both drugs are standard treatments for prostate cancer.

Patient Parameters

Program Overview

The study aims to compare the effects of two prostate cancer treatments, Relugolix and Leuprolide, on quality of life and various health markers. These drugs are already approved for use in prostate cancer treatment. Participants will be randomly assigned to receive either Relugolix or Leuprolide. The study will involve screening for eligibility, treatment, and follow-up visits, including heart tests and blood tests. The study will last for about 12 months and will include around 110 participants. The Prostate Cancer Foundation and Pfizer are funding the study, and Myovant is providing the drug Relugolix.

Description

This phase 2 clinical trial is focused on comparing the quality of life reported by men with localized or returning prostate cancer who are treated with either Relugolix or Leuprolide. Participants will be randomly assigned to one of the two treatment groups. Randomization means that participants are placed in a group by chance, like flipping a coin. Both Relugolix and Leuprolide are approved by the FDA for treating prostate cancer. The study procedures include checking if participants are eligible, providing the study treatment, and conducting evaluations and follow-up visits, which will include heart tests and blood tests. The study is expected to last for 12 months, and about 110 people will participate. The Prostate Cancer Foundation and Pfizer are funding the study, and Myovant is providing the drug Relugolix.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of prostate cancer.
  • Eligible for 6 months of treatment with either Leuprolide or Relugolix, without other systemic therapies except certain androgen receptor blockers.
  • Must not have had previous GnRH therapy.
  • Testosterone level must be over 200 ng/mL before starting treatment.
  • Must be 18 years or older.
  • Must have a performance status that allows for daily activities.
  • Must have a life expectancy of more than 12 months.
  • Must have adequate blood and organ function based on specific medical tests.
  • HIV-positive participants must have an undetectable viral load on treatment.
  • Hepatitis B and C infections must be under control or cured.
  • Other cancers must not interfere with the study treatment.
  • Must have a cardiac risk assessment if there is a history of heart disease.
  • Must agree to use effective birth control during and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Recent major heart events like heart attack or stroke within the last 6 months.
  • Previous or planned treatment with certain advanced prostate cancer drugs.
  • Participation in other experimental drug studies.
  • Brain metastases, as hormonal therapy is not standard for this condition.
  • Allergic reactions to similar drugs.
  • Uncontrolled illnesses.
  • Inability to swallow pills.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.