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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04600336
Other study ID # A222001
Secondary ID UG1CA189823NCI-2
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 28, 2021
Est. completion date May 2024

Study information

Verified date April 2024
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Relative to placebo, low- or high-dose oxybutynin may reduce hot flashes in men receiving androgen deprivation therapy.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 88
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oxybutynin Chloride
Given PO
Placebo Administration
Given PO
Other:
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Ascension Saint Elizabeth Hospital Appleton Wisconsin
United States Messino Cancer Centers Asheville North Carolina
United States McFarland Clinic - Boone Boone Iowa
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield Wisconsin
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States AtlantiCare Health Park-Cape May Court House Cape May Court House New Jersey
United States Ascension Calumet Hospital Chilton Wisconsin
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States MU Health - University Hospital/Ellis Fischel Cancer Center Columbia Missouri
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
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 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 Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States AtlantiCare Surgery Center Egg Harbor Township New Jersey
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
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 McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Ascension Saint Francis - Reiman Cancer Center Franklin Wisconsin
United States Unity Hospital Fridley Minnesota
United States Arizona Breast Cancer Specialists-Gilbert Gilbert Arizona
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Altru Cancer Center Grand Forks North Dakota
United States Grand Valley Oncology Grand Junction Colorado
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States University of Mississippi Medical Center Jackson Mississippi
United States Baptist MD Anderson Cancer Center Jacksonville Florida
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States McFarland Clinic - Jefferson Jefferson Iowa
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 McFarland Clinic - Marshalltown Marshalltown Iowa
United States Sovah Health Martinsville Martinsville Virginia
United States Fremont - Rideout Cancer Center Marysville California
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Ascension Columbia Saint Mary's Hospital Ozaukee Mequon Wisconsin
United States Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee Wisconsin
United States Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee Wisconsin
United States Zablocki Veterans Administration Medical Center Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Monticello Cancer Center Monticello Minnesota
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States NYP/Weill Cornell Medical Center New York New York
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States Ascension Mercy Hospital Oshkosh Wisconsin
United States Arizona Center for Cancer Care-Peoria Peoria Arizona
United States Arizona Breast Cancer Specialists-Phoenix Phoenix Arizona
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Ascension All Saints Hospital Racine Wisconsin
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic in Rochester Rochester Minnesota
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
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 Arizona Breast Cancer Specialists Scottsdale Arizona
United States Arizona Breast Cancer Specialists-Scottsdale Scottsdale Arizona
United States Saint Francis Regional Medical Center Shakopee Minnesota
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 Memorial Medical Center Springfield Illinois
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Lakeview Hospital Stillwater Minnesota
United States Arizona Center for Cancer Care-Surprise Surprise Arizona
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Carle Cancer Center Urbana Illinois
United States Ridgeview Medical Center Waconia Minnesota
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 Rice Memorial Hospital Willmar Minnesota
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 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. At 6 weeks, the proportion of patients who experience a 50% or greater reduction in hot flash scores since baseline will be compared across the oxybutynin and placebo arms using Fisher's exact test or logistic regression. Baseline up to 6 weeks post-randomization
Secondary 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. At 6 weeks, the proportion of patients who experience a 50% or greater reduction in hot flash frequency since baseline will be compared across the oxybutynin and placebo arms using Fisher's exact test or logistic regression. Consistency of the results will be assessed across the various methods used to evaluate the efficacy of oxybutynin in this trial (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). Baseline up to 6 weeks post-randomization
Secondary Incidence of adverse events 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. Baseline up to 12 weeks post-randomization
Secondary 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. Estimates from the mixed model will be used to construct 90% confidence intervals for mean differences in patient-reported symptoms between the oxybutynin and placebo arms at 6 weeks. Contrasts estimated via the mixed model will involve a two-sided t-test with alpha = .10. Baseline and at the end of each week of treatment, assessed up to 6 weeks post-randomization
Secondary Patient accrual The time required to accrue 87 patients will be reported. Up to 2 years
Secondary Treatment adherence rates 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. Up to 2 years
Secondary Patient-reported quality of life: scale 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. Estimates from the mixed model will be used to construct 90% confidence intervals for mean differences in patient-reported quality of life between the oxybutynin and placebo arms at 6 weeks. Contrasts estimated via the mixed model will involve a two-sided t-test with alpha = .10. Baseline and at the end of each week of treatment, assessed up to 6 weeks post-randomization
Secondary 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. Estimates from the mixed model will be used to construct 90% confidence intervals for mean differences in patient-reported hot flash interference between the oxybutynin and placebo arms at 6 weeks. Contrasts estimated via the mixed model will involve a two-sided t-test with alpha = .10. Baseline and at the end of each week of treatment, assessed up to 6 weeks post-randomization
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