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Anticholinergic Agent

Oxybutynin for Hot Flashes in Prostate Cancer

Phase 2

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial compares the effect of oxybutynin (a medication) versus placebo for reducing hot flashes in men receiving androgen deprivation therapy (hormone therapy) for the treatment of prostate cancer.

Who is the study for?

Men with prostate cancer on hormone therapy experiencing hot flashes can join this trial. They must be stable on their current treatment for at least 28 days, not planning to stop it within the next 42 days, and have a life expectancy over 6 months. Excluded are those who've used oxybutynin or certain other medications recently, or have specific health conditions like uncontrolled heart disease or narrow-angle glaucoma.Check my eligibility

What is being tested?

This phase II trial is testing if oxybutynin helps reduce hot flashes better than a placebo in men undergoing hormone therapy for prostate cancer. Participants will either receive low- or high-dose oxybutynin or a placebo while continuing their standard treatments.See study design

What are the potential side effects?

Oxybutynin may cause dry mouth, constipation, dizziness, blurred vision, difficulty urinating, and possible allergic reactions. It's important to monitor any new symptoms that arise during the trial and report them to the healthcare team.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had severe hot flashes at least 28 times a week for the last 2 weeks.

Select...

I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient-reported hot flash scores

Secondary outcome measures

Incidence of adverse events

Patient accrual

Patient-reported hot flash frequency

+4 more

Side effects data

From 2018 Phase 3 trial • 150 Patients • NCT02961790

30%

Dry mouth

Urinary retention

Dizziness

Blurred vision

Dry eye

Constipation

Urinary tract pain

Headache

Dyspepsia

Eye disorders - Other, specify

Fatigue

Arthralgia

Nausea

Diarrhea

Skin infection

Concentration impairment

Somnolence

100%

80%

60%

40%

20%

Study treatment Arm

High-dose Oxybutynin Chloride Group

Low-dose Oxybutynin Chloride Group

Placebo Group

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: low-dose oxybutyninExperimental Treatment3 Interventions

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.

Group II: high-dose oxybutynin chlorideExperimental Treatment3 Interventions

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.

Group III: high-dose placeboPlacebo Group3 Interventions

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.

Group IV: low-dose placeboPlacebo Group3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxybutynin Chloride

2016

Completed Phase 3

~150

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,065 Total Patients Enrolled

560 Trials studying Prostate Cancer

507,085 Patients Enrolled for Prostate Cancer

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

217,550 Total Patients Enrolled

29 Trials studying Prostate Cancer

5,836 Patients Enrolled for Prostate Cancer

Bradley J. Stish, MDStudy ChairMayo Clinic

Media Library

Oxybutynin Chloride (Anticholinergic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04600336 — Phase 2

Prostate Cancer Research Study Groups: high-dose placebo, low-dose oxybutynin, high-dose oxybutynin chloride, low-dose placebo

Prostate Cancer Clinical Trial 2023: Oxybutynin Chloride Highlights & Side Effects. Trial Name: NCT04600336 — Phase 2

Oxybutynin Chloride (Anticholinergic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04600336 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any Canadian locations where this medical experiment is taking place?

"There are currently 100 locations with active recruitment efforts for this trial, such as the Ascension Columbia Saint Mary's Hospital Ozaukee in Mequon, the Ascension Columbia Saint Mary's Hospital - Milwaukee in Milwaukee, and Genesys Hurley Cancer Institute in Flint."

Answered by AI

Are there any available slots in this clinical experiment?

"Reading the details listed on clinicaltrials.gov, this medical trial is in need of participants and is currently open for enrollment. It was first posted on July 30th 2021 and received its latest update almost one year later, on September 25th 2022."

Answered by AI

What potential risks should be considered before taking Oxybutynin Chloride?

"Our medical team has rated the safety of Oxybutynin Chloride as a 2 due to its Phase 2 trial status. This grading indicates that there is some data confirming its security, but no efficacy results yet."

Answered by AI

Has Oxybutynin Chloride been analyzed in any other scientific investigations?

"The initial research into oxybutynin chloride was conducted in 2011 at Cedars-Sinai Medical Center - West Hollywood /ID# 237746. Since then, the compound has been tested 291 times with 5 active trials. Of those experiments, many are occurring in Mequon, Wisconsin."

Answered by AI

What is the current sample size of this research endeavor?

"This clinical trial requires 87 qualified participants. Patiens can register out of Ascension Columbia Saint Mary's Hospital Ozaukee in Mequon, Wisconsin and Ascension Columbia Saint Mary's Hospital - Milwaukee in Milwaukee, Michigan."

Answered by AI

Has this trial ever been executed before?

"Currently, 5 distinct clinical trials are running for Oxybutynin Chloride in 102 cities across two nations. AbbVie first initiated a Phase 4 drug approval study with 58 participants back in 2011 and since then, 291 research projects have been conducted."

Answered by AI

What medical purpose does Oxybutynin Chloride typically serve?

"Oxybutynin Chloride is often prescribed to patients suffering from urinary urge incontinence. It can also be used against other medical issues such as neurological disorders, urgency of micturition and detrusor hyperreflexia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04600336.

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