Testosterone Therapy for Prostate Cancer

Overseen By Michael 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

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.

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.

Treatment Details

Interventions

• Enzalutamide (Androgen Receptor Antagonist)
• Transdermal Testosterone (Hormone Therapy)

Trial Overview The 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

Group I: Square Wave Testosterone Therapy + SOC Experimental Treatment 2 Interventions

All patients will receive transdermal testosterone. All patients will also receive standard of care enzalutamide. Patients will alternate between the two therapies.

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+