Study on Sequential Testosterone and Enzalutamide to Prevent Unfavorable Progression in Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04363164

Provider View

This clinical trial is exploring whether a new treatment approach using testosterone and enzalutamide can better manage prostate cancer that has spread and is not responding to standard treatments. The study compares this new method to the usual continuous enzalutamide therapy.

Patient Parameters

Program Overview

The study aims to find out if using a combination of high-dose testosterone and enzalutamide can improve outcomes for men with metastatic castration-resistant prostate cancer (CRPC) that has progressed after previous treatments. Participants will be randomly assigned to different treatment groups to compare the effectiveness of this new approach against the standard continuous enzalutamide therapy.

Description

This study is for men with prostate cancer that has spread and is not responding to standard treatments. Participants will continue their current hormone therapy to keep testosterone levels low. They will be randomly assigned to one of three groups:

  • Group A: Will receive continuous enzalutamide, a standard treatment.
  • Group B: Will receive high-dose testosterone injections followed by enzalutamide in cycles. This involves alternating between testosterone injections and enzalutamide pills every 56 days.
  • Group C: Will receive a variable schedule of testosterone and enzalutamide based on their PSA levels, a marker of prostate cancer activity.

Participants will have regular PSA tests and scans to monitor their cancer. If the cancer progresses, they may switch treatments or stop the study. The study will help determine if this new approach can better control prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of prostate cancer.
  • Currently receiving hormone therapy to lower testosterone levels.
  • Have cancer that has spread and is confirmed by scans.
  • Cancer must have progressed after treatment with abiraterone and hormone therapy.
  • PSA level must be 1.0 ng/mL or higher.
  • Must agree to provide a tumor sample for analysis.
  • No prior treatment with enzalutamide or similar drugs.
  • May have had previous chemotherapy or other specific treatments.
  • Must have acceptable liver and kidney function.
  • Must have adequate blood cell counts.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have pain from prostate cancer that requires medication.
  • Have a performance status indicating severe disability.
  • Have had previous treatment with enzalutamide.
  • Have had chemotherapy for castration-resistant prostate cancer.
  • Require self-catheterization due to prostate issues.
  • Have cancer in areas that could be worsened by testosterone treatment.
  • Have serious medical or psychiatric conditions that could interfere with the study.
  • Have active infections like HIV or hepatitis.
  • Have conditions that affect the ability to consent or comply with the study.
  • Are on certain blood thinners unless they can switch to an allowed medication.
  • Have had a recent blood clot not treated with blood thinners.
  • Have certain blood or heart conditions.
  • Are allergic to specific oils used in the study medications.
  • Have had major surgery recently and have not fully recovered.

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