Safety and Effectiveness of Oral Testosterone Followed by Enzalutamide for Men with Advanced Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05081193

Provider View

This study is testing if oral testosterone followed by enzalutamide can help treat men with advanced prostate cancer that no longer responds to standard hormone therapy. The trial will explore if this approach can maintain high testosterone levels and improve treatment outcomes.

Patient Parameters

Program Overview

This clinical trial is exploring a new treatment approach for men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The study will test oral testosterone taken for one week, followed by a week off, over a 28-day cycle. This cycle will be repeated three times, and then scans will be done to check the cancer's status. If the cancer progresses, patients will switch to enzalutamide, another medication, for three more cycles. The goal is to see if oral testosterone can maintain high levels in the blood and improve treatment results compared to previous injection methods.

Description

Prostate cancer that has spread and no longer responds to hormone therapy is a serious condition affecting many men. Traditional treatments often stop working over time, leading to the need for new approaches. This study is testing a method called Bipolar Androgen Therapy (BAT), which uses high doses of testosterone to target cancer cells. Previous studies used injections, but this trial will use oral testosterone, which may be more convenient and consistent.

The trial will involve taking oral testosterone for one week, followed by a week off, in a 28-day cycle. This will be repeated for three cycles, with scans to check the cancer's progress. If the cancer continues to grow, patients will switch to enzalutamide, a medication that blocks male hormones, for another three cycles. The study aims to see if this approach can improve treatment outcomes and quality of life for men with advanced prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Diagnosed with prostate cancer that has spread.
  • Cancer is not responding to hormone therapy.
  • Have a specific level of testosterone in the blood.
  • Have had certain previous treatments for prostate cancer.
  • Able to provide a tumor sample for analysis.
  • In good overall health with specific blood test results.
  • Willing to continue hormone therapy during the study.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Experiencing pain from cancer that requires strong pain medication.
  • Have had previous treatments for advanced prostate cancer.
  • Need a urinary catheter due to prostate issues.
  • Have cancer in areas that could be risky to treat with testosterone.
  • Have uncontrolled infections like HIV or hepatitis.
  • Have had blood clots in the past two years and are not on blood thinners.
  • Taking certain blood-thinning medications that cannot be changed.
  • Have certain health conditions like high red blood cell count or severe sleep apnea.

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