Study on Ruxolitinib and Enzalutamide for Treating Metastatic Castration-Resistant Prostate Cancer
Sponsor: University of Michigan Rogel Cancer Center
ClinicalTrials ID:NCT06616155
This clinical trial is testing a combination of two drugs, ruxolitinib and enzalutamide, to see if they are safe and effective in treating prostate cancer that has spread and continues to grow despite hormone therapy.
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of combining ruxolitinib and enzalutamide for treating prostate cancer that has spread to other parts of the body and is resistant to hormone therapy. Ruxolitinib works by blocking proteins that help tumors grow, while enzalutamide blocks the effects of male hormones that fuel cancer growth. This combination may help stop the growth and spread of cancer cells.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 or older with prostate cancer that has spread and is resistant to hormone therapy.
- Must have previously confirmed prostate cancer.
- Must understand and sign a consent form.
- Must have undergone surgical or medical castration at least 8 weeks before screening, with low testosterone levels.
- Cancer must have progressed after previous treatment with abiraterone, shown by rising PSA levels.
- Must be considered a poor responder to abiraterone based on specific criteria.
- Current or recent treatment must include androgen deprivation therapy (ADT) and abiraterone.
- Willing to undergo a biopsy of metastatic tumors if possible.
- At least 50% of participants must have measurable disease by specific criteria.
- Must have a performance status score of 0 to 2, indicating good overall health.
- Must agree to use contraception during treatment and for 90 days after the last dose.
- Must meet specific blood count and organ function criteria.
- Must have adequate liver and kidney function as determined by specific tests.
Exclusion Criteria
- History of untreated brain metastasis.
- History of seizures or allergies to study drugs.
- Difficulty swallowing pills or gastrointestinal issues affecting drug absorption.
- Uncontrolled high blood pressure.
- Previous chemotherapy for metastatic castration-resistant prostate cancer.
- Unresolved side effects from previous treatments.
- Active infections like hepatitis B, C, or tuberculosis.
- Recent history of heart attack, stroke, or blood clots.
- Life expectancy less than 6 months or difficulty swallowing medications.
- Currently taking certain medications that interact with study drugs.
- High risk of tuberculosis reactivation.
- Severe liver disease.
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