Oxybutynin for Hot Flashes in Prostate Cancer

Recruiting in Palo Alto (17 mi)

+111 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if oxybutynin can reduce hot flashes in men undergoing hormone therapy for prostate cancer. The medication might help by affecting how the body regulates temperature. Oxybutynin has been used to treat excessive sweating and hot flashes in various patient groups, including those with cancer.

Research Team

Bradley J. Stish, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Men with prostate cancer on hormone therapy experiencing hot flashes can join this trial. They must be stable on their current treatment for at least 28 days, not planning to stop it within the next 42 days, and have a life expectancy over 6 months. Excluded are those who've used oxybutynin or certain other medications recently, or have specific health conditions like uncontrolled heart disease or narrow-angle glaucoma.

Inclusion Criteria

I am a man being treated for prostate cancer with specific hormone therapies, but not with enzalutamide, apalutamide, or darolutamide.

In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English

I have had severe hot flashes at least 28 times a week for the last 2 weeks.

See 3 more

Exclusion Criteria

I am not using and will not use certain medications or supplements for hot flashes during the study.

I do not have any health conditions that react badly to oxybutynin.

I have never used oxybutynin.

Treatment Details

Interventions

Oxybutynin Chloride (Anticholinergic Agent)

Trial OverviewThis phase II trial is testing if oxybutynin helps reduce hot flashes better than a placebo in men undergoing hormone therapy for prostate cancer. Participants will either receive low- or high-dose oxybutynin or a placebo while continuing their standard treatments.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: low-dose oxybutyninExperimental Treatment3 Interventions

Patients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.

Group II: high-dose oxybutynin chlorideExperimental Treatment3 Interventions

Patients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.

Group III: high-dose placeboPlacebo Group3 Interventions

Patients receive a high-dose placebo (5.0 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - high-dose oxybutynin chloride per physician discretion.

Group IV: low-dose placeboPlacebo Group3 Interventions

Patients receive a low-dose placebo (2.5 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - low-dose oxybutynin per physician discretion.