Testosterone Therapy for Prostate Cancer
Trial Summary
What is the purpose of this trial?
This is an open-labeled, single-arm, interventional pilot study. It is being done to determine the feasibility of the administration of transdermal testosterone alternating with enzalutamide, as well as the safety and efficacy.
Do I have to stop taking my current medications for the trial?
If you are on a first-generation anti-androgen medication, you must stop taking it at least 6 weeks before starting the trial. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the study team.
What data supports the effectiveness of the treatment Enzalutamide, Xtandi, and Transdermal Testosterone for prostate cancer?
Recent studies suggest that testosterone therapy, once thought to be unsafe for men with prostate cancer, is now considered a viable option for treating testosterone deficiency in these patients. This shift is based on evidence showing that testosterone therapy can be safe and beneficial, improving well-being and physical strength, although careful monitoring is necessary to ensure prostate safety.12345
Is testosterone therapy safe for people with prostate cancer?
Testosterone therapy has been studied for safety in men with prostate cancer, and while short-term use appears safe, there are concerns about long-term risks, especially regarding prostate health. More large, long-term studies are needed to fully understand the safety of testosterone therapy in this group.56789
How does the treatment Transdermal Testosterone differ from other treatments for prostate cancer?
Transdermal Testosterone is unique because it challenges the traditional belief that testosterone therapy is unsafe for men with prostate cancer. Recent studies suggest that it can be safely used in men with prostate cancer, potentially improving their quality of life by addressing symptoms of low testosterone (hypogonadism) without significantly increasing cancer risk.1281011
Research Team
Laura Graham
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
Men over 18 with advanced prostate cancer that's resistant to castration therapy can join. They must have been on hormone therapy for at least 6 months, show PSA progression despite treatment, and not be in severe pain or on daily narcotics. Participants need normal organ function tests and agree to use two forms of birth control if applicable.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transdermal testosterone alternating with enzalutamide
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Enzalutamide
- Transdermal Testosterone
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Cancer League of Colorado
Collaborator