Study on Using High-Dose Testosterone with Darolutamide for Metastatic Prostate Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials ID:NCT07142551
This clinical trial is exploring a new treatment approach for men with metastatic prostate cancer by alternating high-dose testosterone therapy with the drug darolutamide. The study aims to see if this method can safely improve treatment response and quality of life.
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Program Overview
The purpose of this study is to find out if alternating high doses of testosterone with the drug darolutamide can safely treat men with metastatic prostate cancer. Researchers want to see if this approach can prevent the cancer from becoming resistant to hormone therapy and reduce side effects, improving patients' quality of life. Typically, prostate cancer is treated with drugs that block testosterone, but over time, these treatments can stop working. This study will test if high levels of testosterone, followed by a quick drop, can kill resistant cancer cells and improve the effectiveness of darolutamide.
Description
This study is testing a new way to treat metastatic prostate cancer by alternating high doses of testosterone with darolutamide. Normally, prostate cancer is treated with drugs that block testosterone, but these can stop working over time. Researchers have found that high levels of testosterone, followed by a quick drop, can kill cancer cells that have become resistant to low testosterone levels. This method is called bipolar androgen therapy (BAT). Previous studies showed that BAT is safe and can reduce PSA levels and tumor size in some patients. After BAT, many patients responded better to testosterone-blocking drugs like enzalutamide. Darolutamide, used in this study, is similar to enzalutamide. The study will also look at how this treatment affects quality of life, gene expression, and metabolism.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 or older.
- Good overall health with a performance status of 2 or less.
- Confirmed diagnosis of prostate cancer.
- PSA level of 1.0 ng/ml or higher.
- No previous hormone therapy for recurrent or metastatic prostate cancer, except in specific cases related to radiation therapy.
- No previous treatment with certain prostate cancer drugs like abiraterone or enzalutamide.
- Previous radiation treatment for limited metastatic disease is allowed if it was more than 6 months ago.
- Rising PSA levels on two separate occasions more than 2 weeks apart.
- Evidence of metastatic disease on recent scans.
- Patients with bone pain must be pain-free after a 6-month lead-in phase to continue.
- Willingness to undergo tumor biopsies if applicable.
- Acceptable liver and kidney function based on specific blood tests.
- Adequate blood cell counts.
- Ability to understand and sign a consent form.
Exclusion Criteria
- No previous chemotherapy for prostate cancer.
- No previous treatment with certain targeted agents like Pluvicto.
- No previous treatment with investigational drugs targeting the androgen receptor.
- No serious or unstable medical or psychiatric conditions that could affect safety or consent.
- No conditions that would make testosterone therapy risky, like certain bone or spinal metastases.
- No need for urinary self-catheterization due to prostate cancer or benign prostatic hyperplasia.
- No active uncontrolled infections.
- No conditions affecting the ability to consent or comply with the study.
- Patients on Warfarin or Coumadin must switch to other anticoagulants to participate.
- No untreated severe sleep apnea or uncontrolled heart failure.
- No allergies to sesame or cottonseed oil.
- No major surgery within 3 weeks before screening or unhealed wounds.
- No severe heart conditions or recent heart attacks.
- Must be able to provide informed consent.
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