Study on Difluoromethylornithine and High Dose Testosterone with Enzalutamide for Advanced Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06059118

Provider View

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 a combination of drugs, including difluoromethylornithine (DFMO), high dose testosterone, and enzalutamide, to see if they can improve treatment outcomes.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness of a new treatment combination for men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. Participants will receive a sequence of treatments involving difluoromethylornithine (DFMO), high dose testosterone, and enzalutamide. The goal is to see if this combination can improve treatment results for patients who have not responded to previous therapies.

Description

This study is for men with advanced prostate cancer that has spread and is no longer responding to standard hormone treatments. Participants will continue their current hormone therapy to suppress natural testosterone production. The treatment cycle lasts 119 days and includes:

  1. Taking DFMO pills twice a day for 7 days.
  2. Receiving high dose testosterone injections and continuing DFMO pills for 56 days.
  3. Taking enzalutamide pills daily for 56 days.

Patients will repeat these cycles until the cancer progresses or side effects require stopping the treatment. The study will help determine if this combination of treatments can improve outcomes for men with this type of prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Diagnosed with advanced prostate cancer that has spread.
  • Currently receiving hormone therapy to lower testosterone levels.
  • Cancer has progressed despite previous treatment with abiraterone.
  • Able to provide a tumor sample for analysis.
  • Good overall health with a performance status of 0 to 2.
  • Willing to use effective birth control methods if sexually active with a partner who can become pregnant.
  • Agree to provide tumor samples for research purposes.
  • Meet specific blood and organ function requirements.
  • Able to understand and sign a consent form to participate.

Exclusion Criteria

  • Experiencing pain from cancer that requires opioid medication.
  • Poor overall health with a performance status of 3 or higher.
  • Need for urinary catheterization due to prostate enlargement.
  • Cancer in areas that could be worsened by testosterone treatment.
  • Active, uncontrolled infections.
  • History of severe allergic reactions to study medications.
  • Recent major surgery or not fully recovered from surgery.
  • Significant hearing loss requiring a hearing aid.
  • History of seizures or conditions that increase seizure risk.
  • Currently taking certain blood thinners that cannot be safely stopped.

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