Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis (Q-Urol)

A Phase II Randomized Controlled Trial of a Supplement Containing Quercetin, Bromelain, Rye Flower Pollen, and Papain on Reducing the Severity of Radiation-Induced Prostatitis

This study will assess the difference in prostatitis symptoms in men with localized prostate cancer following brachytherapy taking Q-Urol relative to placebo.

Study Overview

• Status: Suspended
• Conditions: Prostate Adenocarcinoma
• Intervention / Treatment: Drug: Placebo; Drug: Q-Urol

Detailed 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. 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rachel Kingsford; Phone Number: 801-585-0115; Email: rachel.kingsford@hci.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute at University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male subjects aged ≥ 18 years.
• Men with histologically proven localized prostate adenocarcinoma, stage I - III (as defined by AJCC 8th edition), who have selected treatment with brachytherapy with or without external beam radiation, with or without androgen deprivation therapy.
• Fluent in speaking and reading English.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

• Adequate organ function as defined as:

  • Hepatic:

    • Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
    • aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN

  • Renal:

    • Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:

      • Males: ((140-age)×weight[kg])/(serum creatinine [mg/dL]×72)
• Highly effective contraception for both male and their female partners of childbearing potential throughout the study and for at least 5 days after last study treatment administration if the risk of conception exists.
• Median life expectancy ≥ 5 years as calculated by the Lee and Shonberg Index (https://eprognosis.ucsf.edu/leeschonberg.php)
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

• Baseline AUA symptom scores > 15.
• Prior diagnosis of chronic prostatitis type II through IV.
• Subject has received systemic therapy intended for the treatment of prostatitis (including herbal supplements) ≤ 14 days of starting study treatment.
• Subject has received a fluoroquinolone antibiotic (e.g. ciprofloxacin, norfloxacin, ofloxacin levofloxacin, etc.) ≤ 3 days of starting study treatment.
• Subject is actively on anti-inflammatory medications for other medical conditions, unless approved by PI.
• Subject has undergone transurethral resection of the prostate (TURP).
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
• History of irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, and interstitial cystitis-bladder pain syndrome (IC/BPS).
• History of symptomatic hypotension, falls, or syncope
• History of hypoglycemia.
• Actively abusing alcohol or drugs

• Subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

  • Congestive heart failure
  • Diabetes
  • Pulmonary artery hypertension
  • Any clinically significant condition that requires therapy with diuretic medications for any indication other than the management of hypertension.
  • Other clinically significant disorders that would, in the opinion of the treating investigator, preclude safe study participation.
• Known prior severe hypersensitivity to investigational product or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
• Known allergy to pineapple or pineapple containing products.
• Subjects taking prohibited medications as described in Section 7.3 A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Q-Urol; Patients will be randomized in a 1:1 ratio to receive Q-Urol, two capsules, 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.	Drug: Q-Urol; Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.
Placebo Comparator: Arm 2: Placebo; Patients will be randomized in a 1:1 ratio to receive Placebo, two capsules, 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.	Drug: Placebo; placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean peak score of the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)	difference in prostatitis symptoms between treatment and placebo group.	6 weeks post brachytherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of days days medication is taken for treatement of prostate-related pain.	To assess effect on prostatitis-related pain in men with localized prostate cancer following bracytherapy taking Q-Urol relative to placebo.	28 days post brachytherapy
Sexual Health Inventory for Men (SHIM) assessment	Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment SHIM questionnaires SHIM Scores 1-7 Severe Erectile Dysfunction (ED) 8-11 Moderate ED 12-16 Mild to Moderate ED 17-21 Mild ED 22-25 No signs of ED	5 weeks post brachytherapy
Impact on serum biomarkers of inflammation. Markers to include erythrocyte sedimentation rate, C-reactive protein, and prostate-specific antigen (PSA).	inflammation markers will be collected pre- and post-brachytherapy for comparison between treatment and placebo groups.	5 weeks post brachytherapy
adverse events will be characterized for frequency, type ,severity	To assess safety of Q-Urol compared to placebo.	5 weeks
The Expanded Prostate Cancer Index Composite (EPIC) assessment	Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment EPIC questionnaires. Items are standardized to a 0-100 scale and are averaged to calculate a summary score or subscale score.	5 weeks post brachytherapy
The International Prostate Symptom Score (I-PSS) assessment	Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment I-PSS questionnaires. American Urological Association Symptom (AUA) Score Mild = 0-7 Moderate = 8-19 Severe = 20-35	5 weeks post brachytherapy
The Rectal Function Assessment Score (R-FAS) assessment	Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment questionnaires. Responses to the questions are added up for a total between 0-27. Question 10 does not count toward the total score.	5 weeks post brachytherapy

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Farr Labs, LLC
• Investigators: Principal Investigator: Jonathan Tward, MD, PhD, Huntsman Cancer Institute/ University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatitis
• Other Study ID Numbers: HCI129154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No