Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer
Prostate Carcinoma
About this trial
This is an interventional supportive care trial for Prostate Carcinoma
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 next generation androgen axis inhibitor therapies including abiraterone, enzalutamide, apalutamide, and darolutamide are eligible
- 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
Sites / Locations
- Arizona Breast Cancer Specialists-GilbertRecruiting
- Arizona Center for Cancer Care-PeoriaRecruiting
- Cancer Center at Saint Joseph'sRecruiting
- Arizona Breast Cancer Specialists-PhoenixRecruiting
- Arizona Breast Cancer SpecialistsRecruiting
- Arizona Breast Cancer Specialists-ScottsdaleRecruiting
- Arizona Center for Cancer Care-SurpriseRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- Fremont - Rideout Cancer CenterRecruiting
- Gene Upshaw Memorial Tahoe Forest Cancer CenterRecruiting
- Grand Valley OncologyRecruiting
- Baptist MD Anderson Cancer CenterRecruiting
- Hawaii Cancer Care - WestridgeRecruiting
- Hawaii Cancer Care Inc - Waterfront PlazaRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Cancer Care Center of O'FallonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- McFarland Clinic - BooneRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- McFarland Clinic - Trinity Cancer CenterRecruiting
- McFarland Clinic - JeffersonRecruiting
- McFarland Clinic - MarshalltownRecruiting
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - BurnsvilleRecruiting
- Mercy HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Unity HospitalRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Monticello Cancer CenterRecruiting
- New Ulm Medical CenterRecruiting
- North Memorial Medical Health CenterRecruiting
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Fairview Lakes Medical CenterRecruiting
- University of Mississippi Medical CenterRecruiting
- MU Health - University Hospital/Ellis Fischel Cancer CenterRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECCRecruiting
- Nebraska Methodist HospitalRecruiting
- AtlantiCare Health Park-Cape May Court HouseRecruiting
- AtlantiCare Surgery CenterRecruiting
- Montefiore Medical Center-Einstein CampusRecruiting
- Montefiore Medical Center-Weiler HospitalRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- NYP/Weill Cornell Medical CenterRecruiting
- Messino Cancer CentersRecruiting
- Southeastern Medical Oncology Center-ClintonRecruiting
- Southeastern Medical Oncology Center-GoldsboroRecruiting
- Southeastern Medical Oncology Center-JacksonvilleRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Altru Cancer CenterRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Sovah Health MartinsvilleRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- Ascension Saint Elizabeth HospitalRecruiting
- Ascension Southeast Wisconsin Hospital - Elmbrook CampusRecruiting
- Ascension Calumet HospitalRecruiting
- Ascension Saint Francis - Reiman Cancer CenterRecruiting
- Ascension Columbia Saint Mary's Hospital OzaukeeRecruiting
- Ascension Southeast Wisconsin Hospital - Saint Joseph CampusRecruiting
- Ascension Columbia Saint Mary's Hospital - MilwaukeeRecruiting
- Zablocki Veterans Administration Medical Center
- ProHealth D N Greenwald CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Ascension Mercy HospitalRecruiting
- Ascension All Saints HospitalRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Ascension Medical Group Southeast Wisconsin - Mayfair RoadRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
low-dose oxybutynin
high-dose oxybutynin chloride
low-dose placebo
high-dose placebo
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.
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.
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.
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.