Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer
A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Men Receiving Androgen Deprivation Therapy
3 other identifiers
interventional
88
1 country
103
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2021
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedStudy Start
First participant enrolled
October 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2024
CompletedResults Posted
Study results publicly available
March 30, 2025
CompletedMarch 30, 2025
March 1, 2025
2.3 years
October 19, 2020
January 28, 2025
March 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Weekly Patient-reported Hot Flash Scores
Using patients' hot flash diaries, daily hot flash scores will be determined by multiplying the frequency of each defined hot flash grade (mild=1, moderate=2, severe=3, very severe=4) by the severity and summing the values over a 24-hour period. Weekly hot flash scores will be computed by averaging these hot flash scores across 7 days. A score of 0 would mean the patient experienced no hot flashes during the week, and every unit increase reflects more or more severe hot flashes experienced. A mixed model will be estimated that includes baseline and weekly hot flash scores across the 6-week treatment period. Estimates from the mixed model will be used to construct 90% confidence intervals for mean differences in hot flash score reduction from baseline to 6 weeks between the oxybutynin and placebo arms. Contrasts estimated via the mixed model will involve a two-sided t-test with alpha = .10.
6 weeks post-randomization
Secondary Outcomes (6)
Change in Patient-reported Hot Flash Frequency
6 weeks post-randomization
Number of Patients That Experienced a Grade 3+ Adverse Event
12 weeks post-randomization
Patient-reported Symptoms
6 weeks post-randomization
Patient Accrual
26 months
Patients That Completed Treatment
4 months
- +1 more secondary outcomes
Study Arms (4)
low-dose oxybutynin
EXPERIMENTALPatients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
high-dose oxybutynin chloride
EXPERIMENTALPatients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
low-dose placebo
PLACEBO COMPARATORPatients 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.
high-dose placebo
PLACEBO COMPARATORPatients 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.
Interventions
Ancillary studies
Ancillary studies
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (103)
Arizona Breast Cancer Specialists-Gilbert
Gilbert, Arizona, 85297, United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, 85381, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
Arizona Breast Cancer Specialists-Phoenix
Phoenix, Arizona, 85027, United States
Arizona Breast Cancer Specialists
Scottsdale, Arizona, 85251, United States
Arizona Breast Cancer Specialists-Scottsdale
Scottsdale, Arizona, 85258, United States
Arizona Center for Cancer Care-Surprise
Surprise, Arizona, 85374, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161, United States
Grand Valley Oncology
Grand Junction, Colorado, 81505, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
McFarland Clinic - Boone
Boone, Iowa, 50036, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
Ascension Saint Joseph Hospital
Tawas City, Michigan, 48764, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, 68114, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
AtlantiCare Health Park-Cape May Court House
Cape May Court House, New Jersey, 08210, United States
AtlantiCare Surgery Center
Egg Harbor, New Jersey, 08234, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Messino Cancer Centers
Asheville, North Carolina, 28806, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Sovah Health Martinsville
Martinsville, Virginia, 24115, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045, United States
Ascension Calumet Hospital
Chilton, Wisconsin, 53014, United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132, United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097, United States
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Milwaukee, Wisconsin, 53210, United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211, United States
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Ascension Mercy Hospital
Oshkosh, Wisconsin, 54904, United States
Ascension All Saints Hospital
Racine, Wisconsin, 53405, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, 53226, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bradley J. Stish, MD
- Organization
- Mayo Clinic
Study Officials
- STUDY CHAIR
Bradley J. Stish, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 23, 2020
Study Start
October 28, 2021
Primary Completion
February 5, 2024
Study Completion
March 11, 2024
Last Updated
March 30, 2025
Results First Posted
March 30, 2025
Record last verified: 2025-03