Prostate Carcinoma Clinical Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04457232 -
Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation
|
Phase 1 | |
Active, not recruiting |
NCT03661437 -
Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy
|
Early Phase 1 | |
Completed |
NCT02337465 -
KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer
|
N/A | |
Completed |
NCT03013413 -
Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy
|
N/A | |
Recruiting |
NCT06037863 -
Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial
|
N/A | |
Active, not recruiting |
NCT03580499 -
Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
|
N/A | |
Completed |
NCT03326440 -
Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer
|
N/A | |
Recruiting |
NCT04597359 -
To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring
|
Phase 2 | |
Active, not recruiting |
NCT03263650 -
Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC
|
Phase 2 | |
Active, not recruiting |
NCT04299620 -
Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy
|
N/A | |
Completed |
NCT04976257 -
Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion
|
Early Phase 1 | |
Completed |
NCT02957981 -
The Genetic Education for Men Trial: Web-Based Education vs. Standard Care
|
N/A | |
Withdrawn |
NCT03408561 -
Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer
|
N/A | |
Enrolling by invitation |
NCT06347809 -
DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
|
||
Enrolling by invitation |
NCT04254133 -
Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
|
||
Recruiting |
NCT05519878 -
Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers
|
N/A | |
Recruiting |
NCT02994758 -
Development of Diagnostics and Treatment of Urological Cancers
|
N/A | |
Completed |
NCT01497431 -
Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants
|
Phase 1 | |
Active, not recruiting |
NCT00002540 -
Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)
|
N/A | |
Completed |
NCT03101046 -
Treatment of Metastatic Castrate Resistant Prostate Cancer Patients According to Circulating Tumor Cells Kinetic
|
Phase 2 |