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: Terminated
• 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 receive Q-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 (Actual): 10
• Phase: Phase 2

Contacts and Locations

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 American Joint Committee on Cancer (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 Schonberg 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
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)	This outcome will report the mean score of the NIH-CPSI, a 13-item questionnaire. This questionnaire will report 4 sub-scores, Pain, Urinary Symptoms, Quality of Life (QOL) Impact, and Pain + Urinary score, and the total score. Pain: The sum of 6 items (0 No-1 Yes), one scale (0 Never-5 Always), and one scale (0 No Pain-10 Pain as bad as you can imagine); Range: 0-21, higher values indicating worse outcomes. Urinary Symptoms: The sum of 2 urine items (0 Not at all-5 Almost always); Range: 0-10, higher values indicating worse outcomes. QOL Impact: The sum of 2 items (0 None-3 A lot) and 1 scale (0 Delighted-6 Terrible); Range: 0-12, higher values indicating worse outcomes. Pain and Urinary sub-score: The sum of the Pan and Urinary Symptoms scores; Range: 0-31, higher values indicating worse outcomes. Total Score: The sum of all questions; Range: 0-43, higher values indicating worse outcomes. This outcome measure is assessed at 6 weeks after the start of study treatment.	up to 6 weeks after the start of study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Expanded Prostate Cancer Index Composite (EPIC) Assessment	Health Related Quality of Life (HRQOL) will be assessed with EPIC questionnaires. Items are standardized to a 0-100 scale and are averaged to calculate four subscale scores (Urinary Summary, Bowel Summary, Sexual Summary, Hormonal Summary). A higher score (max 100) represents better HRQOL, and a lower score (min 0) represents worse HRQOL.	up to 6 weeks after the start of study treatment
The International Prostate Symptom Score (I-PSS) Assessment	Health Related Quality of Life (HRQOL) will be assessed with International Prostate Symptom Score (I-PSS). This is a questionnaire with 7 questions concerning urinary symptoms (from 0 to 5). A high score (max 35) indicates worse HRQOL and a low score (min 0) represents a better HRQOL. These score are reported as Mild (0-7), moderate (8-19) or Severe (20-35). total score ranges from 0 to 35 (asymptomatic to very symptomatic).	up to 6 weeks after the start of study treatment
The Rectal Function Assessment Score (R-FAS) Assessment	Health Related Quality of Life (HRQOL) will be assessed with the R-FAS 10-item questionnaires. Question 10 does not count toward the total score. 9 questions are scored from 0-3. A higher score represents poorer bowel function (max 27) and a lower score represents better bowel function (min 0).	At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Sexual Health Inventory for Men (SHIM) Assessment	The SHIM is a 5 point questionnaire with ratings from 0-5 to assess Health Related Quality of Life (HRQOL). The sum of the SHIM score is categorized to Severe Erectile Dysfunction ED (0-7), Moderate ED (8-11), Mild to Moderate ED (12-16), Mild ED (17-21), No signs of ED (22-25). This outcome will report the count of participants in each category.	At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Impact on Serum Biomarkers of Inflammation - Erythrocyte Sedimentation Rate (ESR)	The inflammation marker, erythrocyte sedimentation rate (ESR), was collected at the End of Treatment visit for comparison between treatment and placebo groups. This outcome will report the mean ESR of each arm.	At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Impact on Serum Biomarkers of Inflammation - C-reactive Protein	The inflammation marker, C-reactive protein, was collected at the End of Treatment visit for comparison between treatment and placebo groups. This outcome will report the mean C-reactive protein of each arm.	At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Impact on Serum Biomarkers of Inflammation - Prostate-specific Antigen (PSA)	The inflammation marker, Prostate-specific antigen (PSA), was collected at the End of Treatment visit for comparison between treatment and placebo arm. This outcome will report the mean PSA of each arm.	At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Adverse Events by Grade	To assess safety of Q-Urol compared to placebo. The severity of adverse events was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity. Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE". This outcome measure will report the following: The count of participants who had a grade 1-2 event, related to study treatment. The count of the participants who had a grade 3-4 event, related to study treatment. The count of the participants who had a grade 5 event or higher. Subjects were monitored for adverse events from the start of treatment until 30 days after the last dose of study treatment.	up to 10.5 weeks after initiation of study treatment
Days of Pain Medication	To assess effect on prostatitis-related pain in men with localized prostate cancer following brachytherapy taking Q-Urol relative to placebo. This outcome will report the mean number of days participants took pain medication as documented on a self reported Pain Management Diary. This was followed for 28 days; the minimum number of days is 0 and the maximum number is 28.	up to 28 days after initiation of study treatment

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): November 14, 2022
• Primary Completion (Actual): December 27, 2023
• Study Completion (Actual): January 25, 2024

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 (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital 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