Testosterone Therapy for Prostate Cancer
MD
Overseen ByMichael D Wacker
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Waitlist Available
Sponsor: University of Colorado, Denver
No Placebo Group
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.
Research Team
LG
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
Provision to sign and date the consent form
Progressive disease at screening as defined by one or more of the following criteria:
My prostate cancer was confirmed by a lab test.
See 17 more
Exclusion Criteria
I have stomach or intestine problems that could affect medicine absorption.
I have not had a heart attack in the last 6 months.
I have had a seizure before or lost consciousness/had a mini-stroke in the last year.
See 14 more
Treatment Details
Interventions
- Enzalutamide (Androgen Receptor Antagonist)
- Transdermal Testosterone (Hormone Therapy)
Trial OverviewThe study is testing the safety and effectiveness of applying testosterone through the skin alternated with a drug called Enzalutamide. It aims to see if this approach is feasible for men whose prostate cancer has stopped responding to standard hormonal treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Square Wave Testosterone Therapy + SOCExperimental Treatment2 Interventions
All patients will receive transdermal testosterone. All patients will also receive standard of care enzalutamide. Patients will alternate between the two therapies.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Trials
1,842
Recruited
3,028,000+
Cancer League of Colorado
Collaborator
Trials
13
Recruited
450+