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Prostate CarcinomaPhase 2NCT04600336

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

A Phase 2 study testing Oxybutynin Chloride, Quality-of-Life Assessment and Questionnaire Administration in people with Prostate Carcinoma, run by Alliance for Clinical Trials in Oncology at 103 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Carcinoma
What is being tested?
Oxybutynin Chloride, Quality-of-Life Assessment and Questionnaire Administration
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
103 sitesUnited States
Study dates
28 Oct 2021to 11 Mar 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

103 sites in 1 country.

103 sites in 1 country

United States103 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Ascension Saint Elizabeth Hospital

    Appleton, Wisconsin, 54915

  • Messino Cancer Centers

    Asheville, North Carolina, 28806

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin, 53045

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • AtlantiCare Health Park-Cape May Court House

    Cape May Court House, New Jersey, 08210

  • Ascension Calumet Hospital

    Chilton, Wisconsin, 53014

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • AtlantiCare Surgery Center

    Egg Harbor, New Jersey, 08234

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Ascension Saint Francis - Reiman Cancer Center

    Franklin, Wisconsin, 53132

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Arizona Breast Cancer Specialists-Gilbert

    Gilbert, Arizona, 85297

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Grand Valley Oncology

    Grand Junction, Colorado, 81505

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Sovah Health Martinsville

    Martinsville, Virginia, 24115

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Ascension Columbia Saint Mary's Hospital Ozaukee

    Mequon, Wisconsin, 53097

  • Ascension Southeast Wisconsin Hospital - Saint Joseph Campus

    Milwaukee, Wisconsin, 53210

  • Ascension Columbia Saint Mary's Hospital - Milwaukee

    Milwaukee, Wisconsin, 53211

  • Zablocki Veterans Administration Medical Center

    Milwaukee, Wisconsin, 53295

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

    Omaha, Nebraska, 68114

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Ascension Mercy Hospital

    Oshkosh, Wisconsin, 54904

  • Arizona Center for Cancer Care-Peoria

    Peoria, Arizona, 85381

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

  • Arizona Breast Cancer Specialists-Phoenix

    Phoenix, Arizona, 85027

  • Ascension All Saints Hospital

    Racine, Wisconsin, 53405

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Ascension Saint Mary's Hospital

    Saginaw, Michigan, 48601

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Arizona Breast Cancer Specialists

    Scottsdale, Arizona, 85251

  • Arizona Breast Cancer Specialists-Scottsdale

    Scottsdale, Arizona, 85258

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Arizona Center for Cancer Care-Surprise

    Surprise, Arizona, 85374

  • Ascension Saint Joseph Hospital

    Tawas City, Michigan, 48764

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Gene Upshaw Memorial Tahoe Forest Cancer Center

    Truckee, California, 96161

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 54401

  • Ascension Medical Group Southeast Wisconsin - Mayfair Road

    Wauwatosa, Wisconsin, 53226

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

  1. 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.

  1. 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.

Being tested
Oxybutynin Chloride, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxybutynin ChlorideDrug

    Given PO

  • Placebo AdministrationDrug

    Given PO

  • Quality-of-Life AssessmentOther

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04600336
Study groupRoleWhat they receive
low-dose oxybutyninExperimentalPatients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
Receives: Drug: Oxybutynin Chloride; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
high-dose oxybutynin chlorideExperimentalPatients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
Receives: Drug: Oxybutynin Chloride; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
low-dose placeboPlacebo 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.
Receives: Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
high-dose placeboPlacebo 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.
Receives: Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks post-randomization

Secondary outcomes (6)

  1. Change in Patient-reported Hot Flash Frequency

    Weekly hot flash frequencies will be determined by patients' hot flash diaries. A mixed model will be estimated that includes baseline and weekly hot flash frequencies across the 6-week treatment period. The mixed model and subsequent contrasts will account for the observed distribution of weekly hot flash frequencies.

    Measured: 6 weeks post-randomization

  2. Number of Patients That Experienced a Grade 3+ Adverse Event

    Grade 3 or higher adverse events will be assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 and summarized by arm.

    Measured: 12 weeks post-randomization

  3. Patient-reported Symptoms

    Patient-reported symptoms will be assessed by the Symptom Experience Questionnaire. A mixed model will be estimated that includes baseline and weekly patient-reported symptoms across the 6-week treatment period. The mean change in answers from baseline to week 6 to the item "How Distressing Was Your Experience With Hot Flashes" will be reported. Answers are given on a scale from 0 to 10 with higher scores being worse; therefore a positive number indicates a worse experience at week 6.

    Measured: 6 weeks post-randomization

  4. Patient Accrual

    The time required to accrue 87 patients will be reported.

    Measured: 26 months

  5. Patients That Completed Treatment

    Treatment adherence rates will be calculated by dividing the number of patients who completed treatment per protocol by the number of patients who started treatment. Treatment adherence rates will be summarized by arm.

    Measured: 4 months

  6. Patient-reported Hot Flash Interference

    A mixed model will be estimated that includes patients' scores on the Hot Flash Related Daily Interference Scale (HFRDIS) across the 6-week treatment period. The mean change in answers from baseline to week 6 to the item "Overall Quality of Life" will be reported. Answers are given on a scale from 0 to 10 with higher scores being worse; therefore a positive number indicates a worse experience at week 6.

    Measured: 6 weeks post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2020
  2. Study start28 Oct 2021
  3. Primary completion5 Feb 2024
  4. Study completion11 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04600336
Sponsor's protocol ID
A222001
Other IDs
UG1CA189823, NCI-2020-07169
Status last verified
Mar 2025
First submitted
19 Oct 2020
Last updated
30 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Stish BJ, Mazza GL, Nauseef JT, Humeniuk MS, Smith TJ, Tofthagen C, Diaz Pardo DA, Chay C, Huang AJ, Naha K, Tagawa ST, Chow S, Ruddy KJ, Lustberg MB, Adams-Campbell LL, Novotny PJ, Loprinzi CL. Alliance A222001: Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Patients Receiving Androgen-Deprivation Therapy for Prostate Cancer. J Clin Oncol. 2026 May;44(13):1198-1205. doi: 10.1200/JCO-25-01486. Epub 2026 Jan 26.

    PubMed 41587370

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxybutynin Chloride, Quality-of-Life Assessment and Questionnaire Administration in people with Prostate Carcinoma, run by Alliance for Clinical Trials in Oncology at 103 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weekly Patient-reported Hot Flash Scores (time frame: 6 weeks post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04600336, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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