NCT04600336CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 19 Oct 2020
- Start date
- 28 Oct 2021
- Primary completion date
- 5 Feb 2024
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Diseases
- Prostate cancer
- NCT number
- NCT04600336
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 88
- From 28 Oct 2021 to the primary completion date, 5 Feb 2024
- 103 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (103)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hawaii Cancer Care - Westridge Coordinator of this site? Confirm its status | ‘Aiea | United States | Unknown status |
| McFarland Clinic - Ames Coordinator of this site? Confirm its status | Ames | United States | Unknown status |
| Mary Greeley Medical Center Coordinator of this site? Confirm its status | Ames | United States | Unknown status |
| Langlade Hospital and Cancer Center Coordinator of this site? Confirm its status | Antigo | United States | Unknown status |
| Ascension Saint Elizabeth Hospital Coordinator of this site? Confirm its status | Appleton | United States | Unknown status |
| Messino Cancer Centers Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| McFarland Clinic - Boone Coordinator of this site? Confirm its status | Boone | United States | Unknown status |
| Ascension Southeast Wisconsin Hospital - Elmbrook Campus Coordinator of this site? Confirm its status | Brookfield | United States | Unknown status |
| Fairview Ridges Hospital Coordinator of this site? Confirm its status | Burnsville | United States | Unknown status |
| Minnesota Oncology - Burnsville Coordinator of this site? Confirm its status | Burnsville | United States | Unknown status |
| AtlantiCare Health Park-Cape May Court House Coordinator of this site? Confirm its status | Cape May Court House | United States | Unknown status |
| Ascension Calumet Hospital Coordinator of this site? Confirm its status | Chilton | United States | Unknown status |
| Southeastern Medical Oncology Center-Clinton Coordinator of this site? Confirm its status | Clinton | United States | Unknown status |
| MU Health - University Hospital/Ellis Fischel Cancer Center Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Mercy Hospital Coordinator of this site? Confirm its status | Coon Rapids | United States | Unknown status |
| Carle at The Riverfront Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Cancer Care Specialists of Illinois - Decatur Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Decatur Memorial Hospital Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Medical Oncology and Hematology Associates-Des Moines Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Mercy Medical Center - Des Moines Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Iowa Methodist Medical Center Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Fairview Southdale Hospital Coordinator of this site? Confirm its status | Edina | United States | Unknown status |
| Crossroads Cancer Center Coordinator of this site? Confirm its status | Effingham | United States | Unknown status |
| Carle Physician Group-Effingham Coordinator of this site? Confirm its status | Effingham | United States | Unknown status |
| AtlantiCare Surgery Center Coordinator of this site? Confirm its status | Egg Harbor | United States | Unknown status |
| Sanford Roger Maris Cancer Center Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Sanford Broadway Medical Center Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Genesee Cancer and Blood Disease Treatment Center Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Genesys Hurley Cancer Institute Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Genesee Hematology Oncology PC Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| McFarland Clinic - Trinity Cancer Center Coordinator of this site? Confirm its status | Fort Dodge | United States | Unknown status |
| Ascension Saint Francis - Reiman Cancer Center Coordinator of this site? Confirm its status | Franklin | United States | Unknown status |
| Unity Hospital Coordinator of this site? Confirm its status | Fridley | United States | Unknown status |
| Arizona Breast Cancer Specialists-Gilbert Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Southeastern Medical Oncology Center-Goldsboro Coordinator of this site? Confirm its status | Goldsboro | United States | Unknown status |
| Altru Cancer Center Coordinator of this site? Confirm its status | Grand Forks | United States | Unknown status |
| Grand Valley Oncology Coordinator of this site? Confirm its status | Grand Junction | United States | Unknown status |
| Hawaii Cancer Care Inc - Waterfront Plaza Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Southeastern Medical Oncology Center-Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Baptist MD Anderson Cancer Center Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| McFarland Clinic - Jefferson Coordinator of this site? Confirm its status | Jefferson | United States | Unknown status |
| Fairview Clinics and Surgery Center Maple Grove Coordinator of this site? Confirm its status | Maple Grove | United States | Unknown status |
| Minnesota Oncology Hematology PA-Maplewood Coordinator of this site? Confirm its status | Maplewood | United States | Unknown status |
| Saint John's Hospital - Healtheast Coordinator of this site? Confirm its status | Maplewood | United States | Unknown status |
| McFarland Clinic - Marshalltown Coordinator of this site? Confirm its status | Marshalltown | United States | Unknown status |
| Sovah Health Martinsville Coordinator of this site? Confirm its status | Martinsville | United States | Unknown status |
| Fremont - Rideout Cancer Center Coordinator of this site? Confirm its status | Marysville | United States | Unknown status |
| Carle Physician Group-Mattoon/Charleston Coordinator of this site? Confirm its status | Mattoon | United States | Unknown status |
| Ascension Columbia Saint Mary's Hospital Ozaukee Coordinator of this site? Confirm its status | Mequon | United States | Unknown status |
| Zablocki Veterans Administration Medical Center Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Ascension Columbia Saint Mary's Hospital - Milwaukee Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Abbott-Northwestern Hospital Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Hennepin County Medical Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Monticello Cancer Center Coordinator of this site? Confirm its status | Monticello | United States | Unknown status |
| ProHealth D N Greenwald Center Coordinator of this site? Confirm its status | Mukwonago | United States | Unknown status |
| Cancer Center of Western Wisconsin Coordinator of this site? Confirm its status | New Richmond | United States | Unknown status |
| New Ulm Medical Center Coordinator of this site? Confirm its status | New Ulm | United States | Unknown status |
| NYP/Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| ProHealth Oconomowoc Memorial Hospital Coordinator of this site? Confirm its status | Oconomowoc | United States | Unknown status |
| Cancer Care Center of O'Fallon Coordinator of this site? Confirm its status | O'Fallon | United States | Unknown status |
| Nebraska Methodist Hospital Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Ascension Mercy Hospital Coordinator of this site? Confirm its status | Oshkosh | United States | Unknown status |
| Arizona Center for Cancer Care-Peoria Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Cancer Center at Saint Joseph's Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Arizona Breast Cancer Specialists-Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Ascension All Saints Hospital Coordinator of this site? Confirm its status | Racine | United States | Unknown status |
| North Memorial Medical Health Center Coordinator of this site? Confirm its status | Robbinsdale | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Delbert Day Cancer Institute at PCRMC Coordinator of this site? Confirm its status | Rolla | United States | Unknown status |
| Oncology Hematology Associates of Saginaw Valley PC Coordinator of this site? Confirm its status | Saginaw | United States | Unknown status |
| Ascension Saint Mary's Hospital Coordinator of this site? Confirm its status | Saginaw | United States | Unknown status |
| Park Nicollet Clinic - Saint Louis Park Coordinator of this site? Confirm its status | Saint Louis Park | United States | Unknown status |
| United Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
| Regions Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
| Arizona Breast Cancer Specialists-Scottsdale Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Arizona Breast Cancer Specialists Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Saint Francis Regional Medical Center Coordinator of this site? Confirm its status | Shakopee | United States | Unknown status |
| Sanford Cancer Center Oncology Clinic Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Southern Illinois University School of Medicine Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Springfield Clinic Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Memorial Medical Center Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Lakeview Hospital Coordinator of this site? Confirm its status | Stillwater | United States | Unknown status |
| Arizona Center for Cancer Care-Surprise Coordinator of this site? Confirm its status | Surprise | United States | Unknown status |
| Ascension Saint Joseph Hospital Coordinator of this site? Confirm its status | Tawas City | United States | Unknown status |
| Montefiore Medical Center-Einstein Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Montefiore Medical Center-Weiler Hospital Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Coordinator of this site? Confirm its status | Truckee | United States | Unknown status |
| University of Arizona Cancer Center-North Campus Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Carle Cancer Center Coordinator of this site? Confirm its status | Urbana | United States | Unknown status |
| Ridgeview Medical Center Coordinator of this site? Confirm its status | Waconia | United States | Unknown status |
| UW Cancer Center at ProHealth Care Coordinator of this site? Confirm its status | Waukesha | United States | Unknown status |
| Aspirus Regional Cancer Center Coordinator of this site? Confirm its status | Wausau | United States | Unknown status |
| Ascension Medical Group Southeast Wisconsin - Mayfair Road Coordinator of this site? Confirm its status | Wauwatosa | United States | Unknown status |
| Rice Memorial Hospital Coordinator of this site? Confirm its status | Willmar | United States | Unknown status |
| Aspirus Cancer Care - Wisconsin Rapids Coordinator of this site? Confirm its status | Wisconsin Rapids | United States | Unknown status |
| Minnesota Oncology Hematology PA-Woodbury Coordinator of this site? Confirm its status | Woodbury | United States | Unknown status |
| Fairview Lakes Medical Center Coordinator of this site? Confirm its status | Wyoming | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.