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Oxybutynin Chloride for Prostate Cancer

Hawaii Cancer Care - Westridge, 'Aiea, HI
Prostate CancerOxybutynin Chloride - Drug
Eligibility
18+
Male
What conditions do you have?
Select

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.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Pilot Trial: Osanetant 28 Days
2
Elinzanetant (BAY3427080)
2
Elinzanetant (BAY3427080)

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 2 years

Week 6
Hot flushes
Patient-reported quality of life: scale
Patient-reported symptoms
Week 12
Incidence of adverse events
Week 6
Patient-reported hot flash frequency
Patient-reported hot flash scores
Up to 2 years
Patient accrual
Treatment adherence rates

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Pilot Trial: Osanetant 28 Days
3
Elinzanetant (BAY3427080)
3
Elinzanetant (BAY3427080)

Side Effects for

High-dose Oxybutynin Chloride Group
30%Dry mouth
9%Urinary retention
7%Blurred vision
7%Dry eye
7%Dizziness
4%Constipation
2%Eye disorders - Other, specify
2%Diarrhea
2%Dyspepsia
2%Nausea
2%Fatigue
2%Skin infection
2%Arthralgia
2%Concentration impairment
2%Headache
2%Somnolence
2%Urinary tract pain
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT02961790) in the High-dose Oxybutynin Chloride Group ARM group. Side effects include: Dry mouth with 30%, Urinary retention with 9%, Blurred vision with 7%, Dry eye with 7%, Dizziness with 7%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

8 Treatment Groups

high-dose oxybutynin chloride
1 of 8
low-dose oxybutynin
1 of 8
Arm B (high-dose oxybutynin chloride)
1 of 8
Arm A (low-dose oxybutynin)
1 of 8
high-dose placebo
1 of 8
low-dose placebo
1 of 8
Arm C (low-dose placebo)
1 of 8
Arm D (high-dose placebo)
1 of 8

Experimental Treatment

Non-Treatment Group

87 Total Participants · 8 Treatment Groups

Primary Treatment: Oxybutynin Chloride · Has Placebo Group · Phase 2

high-dose oxybutynin chlorideExperimental Group · 3 Interventions: Oxybutynin Chloride, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Other, Other
low-dose oxybutyninExperimental Group · 3 Interventions: Oxybutynin Chloride, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Other, Other
Arm B (high-dose oxybutynin chloride)Experimental Group · 3 Interventions: Oxybutynin Chloride, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Other, Other
Arm A (low-dose oxybutynin)Experimental Group · 3 Interventions: Oxybutynin Chloride, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Other, Other
high-dose placeboPlaceboComparator Group · 3 Interventions: Placebo Administration, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Other, Other
low-dose placeboPlaceboComparator Group · 3 Interventions: Placebo Administration, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Other, Other
Arm C (low-dose placebo)PlaceboComparator Group · 3 Interventions: Placebo Administration, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Other, Other
Arm D (high-dose placebo)PlaceboComparator Group · 3 Interventions: Placebo Administration, Questionnaire Administration, Quality-of-Life Assessment · Intervention Types: Drug, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxybutynin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
507 Previous Clinical Trials
218,553 Total Patients Enrolled
29 Trials studying Prostate Cancer
5,836 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,279 Previous Clinical Trials
41,234,771 Total Patients Enrolled
542 Trials studying Prostate Cancer
503,508 Patients Enrolled for Prostate Cancer
Bradley J. Stish, MDStudy ChairMayo Clinic

Eligibility Criteria

Age 18+ · Male Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 6 more months.
You have been experiencing hot flashes that are bothering you for at least two weeks. These hot flashes are happening at least 28 times a week and are severe enough that you need treatment to help with them.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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