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

NCT04252625 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HCI129154
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The Expanded Prostate Cancer Index Composite (EPIC) Assessment

  up to 6 weeks after the start of study treatment

• The International Prostate Symptom Score (I-PSS) Assessment

  up to 6 weeks after the start of study treatment

• The Rectal Function Assessment Score (R-FAS) Assessment

  At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.

• Sexual Health Inventory for Men (SHIM) Assessment

  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)

  At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.

Study Arms (2)

Arm 1: Q-Urol

ACTIVE COMPARATOR

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

Arm 2: Placebo

PLACEBO COMPARATOR

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

Interventions

Q-Urol DRUG

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.

Arm 1: Q-Urol

Placebo DRUG

placebo capsule

Arm 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male subjects ≥ 18 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Farr Labs, LLC: collaborator

Study Sites (2)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Results Point of Contact

• Title: IIT Data Management Team
• Organization: Research Compliance Office, Huntsman Cancer Institute

IITDataManagement@hci.utah.edu

801-213-6215

Study Officials

• Jonathan Tward, MD, PhD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An asymmetric two-sided group sequential design will be used with an interim analysis for efficacy and futility.

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: February 5, 2020
• Study Start: November 14, 2022
• Primary Completion: December 27, 2023
• Study Completion: January 25, 2024
• Last Updated: January 28, 2026
• Results First Posted: May 6, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)