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

January 19, 2022

Protocol: Alliance – A222001

SCHEMA Alliance A222001

Please Note: Below is partial eligibility, please contact GHCI Research Department for full eligibility requirements at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

  1. Men who are currently receiving androgen deprivation therapy for the treatment of prostate cancer.
  2. 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.
  3. Patients must have bothersome hot flashes for greater to or equal to 14 days prior to registration, defined by an occurrence of greater to or equal to 28 times per week and of sufficient severity to cause the patient to seek therapeutic intervention.
  4. No current or prior use of oxybutynin.
  5. Must be 18 years of age.
  6. Patients with urinary retention requiring indwelling or intermittent self-catheterization within the prior 6 months are not eligible.
  7. Life expectancy of greater than 6 months.
  8. ECOG Performance Status 0-2

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