Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostate Carcinoma

In brief

This phase II trial compares the effect of oxybutynin versus placebo for reducing hot flashes in men receiving androgen deprivation (hormone) therapy for the treatment of prostate cancer . Androgen deprivation therapy decreases testosterone and other androgens through medications or surgical removal of the testicles. Relative to placebo, low- or high-dose oxybutynin may reduce hot flashes in men receiving androgen deprivation therapy.

Key facts

Study ID

NCT04600336

Run by

Alliance for Clinical Trials in Oncology

People needed

88

Starts

2021-10-28

Expected to finish

2024-03-11

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men who are currently receiving androgen deprivation therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists. Men receiving abiraterone, but not enzalutamide, apalutamide, and darolutamide are eligible, as the latter three are metabolized by CYP3A4 and may affect oxybutynin serum concentrations.
• Patients must be on a stable dose of all hormone-directed therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration. Patients receiving radiation therapy during the study period are eligible
• Eligible patient must have bothersome hot flashes for >= 14 days prior to registration, defined by an occurrence of >= 28 times per week and of sufficient severity to cause the patient to seek therapeutic intervention
• Life expectancy of greater than 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, or 2
• In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English

You may not qualify if…

• No current use or future planned use of any of the following agents during the study period: drugs that are not Food and Drug Administration (FDA) approved for use in humans, androgens, estrogens, progesterone analogs, gabapentin, selective serotonin reuptake inhibitor (SSRI)/serotonin and norepinephrine reuptake inhibitor (SNRI) anti-depressants, cholinergic agonists, cholinesterase inhibitors, or complementary/alternative medicine taken for the purpose of managing hot flashes. Prior use of these agents is permitted as long as they are discontinued before registration
• No current or prior use of oxybutynin
• Patients with a history of any of the following contraindications to oxybutynin are not eligible: gastroparesis or gastrointestinal obstructive disorders; significant gastric reflux symptoms not controlled by medication; ulcerative colitis; narrow-angle glaucoma; urinary retention requiring indwelling or intermittent self-catheterization within the prior 6 months; hypersensitivity to oxybutynin or any other components of the product; current uncontrolled hyperthyroidism; uncontrolled coronary artery disease or a history of myocardial infarction within the prior 12 months; New York Heart Association (NYHA) class II-IV congestive heart failure; symptomatic cardiac arrhythmias; current uncontrolled hypertension; myasthenia gravis; or dementia

Where it is running

• Arizona Center for Cancer Care-Peoria — Peoria, Arizona, United States
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• Arizona Breast Cancer Specialists-Phoenix — Phoenix, Arizona, United States
• Arizona Breast Cancer Specialists — Scottsdale, Arizona, United States
• Arizona Breast Cancer Specialists-Scottsdale — Scottsdale, Arizona, United States
• Arizona Center for Cancer Care-Surprise — Surprise, Arizona, United States
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• Gene Upshaw Memorial Tahoe Forest Cancer Center — Truckee, California, United States
• Grand Valley Oncology — Grand Junction, Colorado, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States
• Hawaii Cancer Care - Westridge — ‘Aiea, Hawaii, United States
• Carle at The Riverfront — Danville, Illinois, United States
• Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Carle Physician Group-Effingham — Effingham, Illinois, United States
• Crossroads Cancer Center — Effingham, Illinois, United States
• Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
• Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• Memorial Medical Center — Springfield, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Arizona Breast Cancer Specialists-Gilbert — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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