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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Eligibility last updated 11/22/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Eau Claire, Wis.

Mayo Clinic principal investigator

Eyad Al-Hattab, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Bradley Stish, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Albert Lea, Minn.

Mayo Clinic principal investigator

Mina Hanna, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions