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

NCT ID: NCT04600336

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-28
• Study Completion Date: 2024-03-11

Brief Summary

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.

Detailed Description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVE:

I. To assess the effects of two doses of oxybutynin chloride (oxybutynin) on hot flash scores relative to placebo.

SECONDARY OBJECTIVES:

I. To assess study accrual rates and compliance with the therapy. II. To characterize the safety and adverse event profile of two doses of oxybutynin in the study population.

III. To evaluate the consistency of the results across the various methods used to evaluate the efficacy of oxybutynin (i.e., hot flash scores versus hot flash frequencies, mean differences versus 50% or greater reduction since baseline, single day versus full week to define patients' baseline hot flash scores).

IV. To compare patient-reported quality of life and hot flash interference, as measured by the Hot Flash Related Daily Interference Scale (HFRDIS), across arms.

V. To compare other changes in patient symptoms, as measured by the Symptom Experience Questionnaire, across arms.

OUTLINE: Patients are randomized to 1 of 4 arms in a 2:2:1:1 ratio according to the dynamic allocation scheme.

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

Experimental Arm (high dose): Patients receive high-dose oxybutynin chloride PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.

Placebo Arm (low dose): Patients receive low-dose placebo PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to Experimental Arm (low dose) per physician discretion.

Placebo Arm (high dose): Patients receive high-dose placebo PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to Experimental Arm (high dose) per physician discretion.

There will be a 6-week follow-up for the Placebo Arm patients who participate in the optional crossover phase.

Conditions

Prostate Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

low-dose oxybutynin

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 Type: EXPERIMENTAL

Oxybutynin Chloride

Intervention Type: DRUG

Given PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

high-dose oxybutynin chloride

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 Type: EXPERIMENTAL

Oxybutynin Chloride

Intervention Type: DRUG

Given PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

low-dose placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo Administration

Intervention Type: DRUG

Given PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

high-dose placebo

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 Type: PLACEBO_COMPARATOR

Placebo Administration

Intervention Type: DRUG

Given PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Oxybutynin Chloride

Given PO

Intervention Type: DRUG

Placebo Administration

Given PO

Intervention Type: DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley J. Stish, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

Arizona Breast Cancer Specialists-Gilbert

Gilbert, Arizona, United States

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

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic - Ames

Ames, Iowa, United States

McFarland Clinic - Boone

Boone, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, United States

Genesee Hematology Oncology PC

Flint, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Ascension Saint Mary's Hospital

Saginaw, Michigan, United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Ascension Saint Joseph Hospital

Tawas City, Michigan, United States

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Monticello Cancer Center

Monticello, Minnesota, United States

New Ulm Medical Center

New Ulm, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Omaha, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

AtlantiCare Health Park-Cape May Court House

Cape May Court House, New Jersey, United States

AtlantiCare Surgery Center

Egg Harbor, New Jersey, United States

NYP/Weill Cornell Medical Center

New York, New York, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Messino Cancer Centers

Asheville, North Carolina, United States

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Altru Cancer Center

Grand Forks, North Dakota, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Sovah Health Martinsville

Martinsville, Virginia, United States

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Ascension Saint Elizabeth Hospital

Appleton, Wisconsin, United States

Ascension Southeast Wisconsin Hospital - Elmbrook Campus

Brookfield, Wisconsin, United States

Ascension Calumet Hospital

Chilton, Wisconsin, United States

Ascension Saint Francis - Reiman Cancer Center

Franklin, Wisconsin, United States

Ascension Columbia Saint Mary's Hospital Ozaukee

Mequon, Wisconsin, United States

Ascension Southeast Wisconsin Hospital - Saint Joseph Campus

Milwaukee, Wisconsin, United States

Ascension Columbia Saint Mary's Hospital - Milwaukee

Milwaukee, Wisconsin, United States

Zablocki Veterans Administration Medical Center

Milwaukee, Wisconsin, United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Ascension Mercy Hospital

Oshkosh, Wisconsin, United States

Ascension All Saints Hospital

Racine, Wisconsin, United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Ascension Medical Group Southeast Wisconsin - Mayfair Road

Wauwatosa, Wisconsin, United States

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UG1CA189823

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2020-07169

Identifier Type: REGISTRY

Identifier Source: secondary_id

A222001

Identifier Type: -

Identifier Source: org_study_id