Study on Testosterone Recovery After Androgen Deprivation Therapy with Relugolix and Darolutamide (CLEARED)

Sponsor: Atish Choudhury, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06463457

Provider View

This study aims to find out how well testosterone levels recover after two years of treatment with the drugs relugolix and darolutamide, and to check the safety of using these drugs together.

Patient Parameters

Program Overview

This research is focused on understanding how testosterone levels return to normal after completing two years of treatment with a combination of relugolix and darolutamide. The study will also evaluate the safety of these drugs when used together. Relugolix is a medication that blocks certain hormones, while darolutamide blocks male hormones from affecting cancer cells. Participants will be divided into two groups to measure how much of each drug is in the bloodstream at different times. The study involves regular visits, blood tests, and possibly scans to monitor health and treatment effects. About 33 participants are expected to join this study, which is funded by Bayer AG, Pfizer, and Sumitomo Pharma America.

Description

This study is designed to see how testosterone levels recover after two years of treatment with relugolix and darolutamide. Participants will be divided into two groups to measure drug levels in the blood at different times. Group 1 will have blood tests at 2, 4, and 8 hours after taking the drugs, while Group 2 will have tests at 1 day, 7 days, and 28 days. The study will also check the safety and how well participants tolerate the drugs.

Relugolix is approved for treating advanced prostate cancer, and darolutamide is approved for certain types of prostate cancer. However, using them together in this way is not yet approved by the FDA. Participants will undergo screening, regular visits, and tests, including blood tests and possibly scans like CT or MRI, to monitor their health. The study will last for two years of treatment, followed by 18 months of follow-up.

The study is funded by Bayer AG, Pfizer, and Sumitomo Pharma America, who are also providing the study drugs.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed prostate cancer.
  • Cancer must be hormone-sensitive and planned for two years of hormone therapy.
  • Must be 18 years or older.
  • Must have good overall health and organ function.
  • Must not have any active infections or other serious health issues.
  • Must agree to use contraception during the study.
  • Must be able to swallow pills and understand the study details.

Exclusion Criteria

  • Cannot have had previous systemic therapy for the current cancer stage.
  • Cannot have rising PSA levels with low testosterone.
  • Cannot be on other investigational drugs.
  • Cannot have brain or other visceral metastases.
  • Cannot have allergies to similar drugs.
  • Cannot have significant drug interactions with study drugs.
  • Cannot have uncontrolled health issues or psychiatric conditions.
  • Pregnant or nursing women cannot participate.
  • Cannot have another active cancer, except for certain non-threatening types.

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