Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Prostate Adenocarcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: An asymmetric two-sided group sequential design will be used with an interim analysis for efficacy and futility.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: double-blinded, placebo-controlledPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
This is a Phase 2, double-blinded, placebo-controlled trial assessing the safety of Q-Urol use after brachytherapy placement in patients with localized prostate cancer. Patients will be randomized in a 1:1 ratio to receiveQ-Urol/Placebo twice daily for 6 weeks after brachytherapy placement. Question...
This is a Phase 2, double-blinded, placebo-controlled trial assessing the safety of Q-Urol use after brachytherapy placement in patients with localized prostate cancer. Patients will be randomized in a 1:1 ratio to receiveQ-Urol/Placebo twice daily for 6 weeks after brachytherapy placement. Questionnaires will be administered pre- and post-treatment to assess the change in prostatitis symptoms and quality of life measures. The mean values between groups will be compared.
Tracking Information
- NCT #
- NCT04252625
- Collaborators
- Farr Labs, LLC
- Investigators
- Principal Investigator: Jonathan Tward, MD, PhD Huntsman Cancer Institute/ University of Utah
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