CClinicalTrials.gg
Sign In
TerminatedNCT04252625Q-UrolUpdated Jan 28, 2026Results posted

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

A Phase 2 interventional study of Q-Urol and Placebo in Prostate Adenocarcinoma, sponsored by University of Utah. Terminated at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by University of Utah · Phase 2, Interventional, and Treatment

Why this study was terminated
Drug Supply Issue
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Prostate Adenocarcinoma
03

In context

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugQ-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.

  • DrugPlacebo

    placebo capsule

06

What researchers measure

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.

    Time frame: up to 6 weeks after the start of study treatment

Secondary outcomes

  1. 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.

    Time frame: up to 6 weeks after the start of study treatment

  2. 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).

    Time frame: up to 6 weeks after the start of study treatment

  3. 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).

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

    Time frame: up to 10.5 weeks after initiation of study treatment

  9. 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.

    Time frame: up to 28 days after initiation of study treatment

07

Results

Posted May 6, 2025

Participant flow

Participant flow — Overall Study
MilestoneArm 1: Q-UrolArm 2: Placebo
Started55
Completed55
Not completed00

Outcome measures

PrimaryNational 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.

Time frame:
up to 6 weeks after the start of study treatment
Reported as:
Mean · score on a scale
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
score on a scaleArm 1: Q-UrolArm 2: Placebo
Pain Score4.00 ± 4.245.8 ± 4.27
Urinary Symptoms Score6.00 ± 2.554.60 ± 2.51
Quality of life impact Score4.80 ± 1.305.20 ± 2.59
Pain score and urinary Score10 ± 5.2410.4 ± 5.13
Total Score14.80 ± 6.3815.60 ± 7.09
SecondaryThe 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.

Time frame:
up to 6 weeks after the start of study treatment
Reported as:
Mean · score on a scale
The Expanded Prostate Cancer Index Composite (EPIC) Assessment
score on a scaleArm 1: Q-UrolArm 2: Placebo
Urinary Summary68.62 ± 10.8964.44 ± 15.87
Bowel Summary85.36 ± 12.0184.37 ± 11.42
Sexual Summary26.44 ± 40.8123.71 ± 17.22
Hormonal Summary72.02 ± 17.8175.03 ± 12.42
SecondaryThe 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).

Time frame:
up to 6 weeks after the start of study treatment
Reported as:
Count of participants · Participants
The International Prostate Symptom Score (I-PSS) Assessment
ParticipantsArm 1: Q-UrolArm 2: Placebo
Mild00
Moderate24
Severe31
SecondaryThe 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).

Time frame:
At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Reported as:
Mean · Score on a scale
The Rectal Function Assessment Score (R-FAS) Assessment
Score on a scaleArm 1: Q-UrolArm 2: Placebo
The Rectal Function Assessment Score (R-FAS) Assessment5.20 ± 2.953.60 ± 3.36
SecondarySexual 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.

Time frame:
At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Reported as:
Count of participants · Participants
Sexual Health Inventory for Men (SHIM) Assessment
ParticipantsArm 1: Q-UrolArm 2: Placebo
Severe Erectile Dysfunction ED (0-7)33
Moderate ED (8-11)01
Mild to Moderate ED (12-16)00
Mild ED (17-21)01
No signs of ED (22-25)10
Not assessed10
SecondaryImpact 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.

Time frame:
At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Reported as:
Mean · mm/hour
Impact on Serum Biomarkers of Inflammation - Erythrocyte Sedimentation Rate (ESR)
mm/hourArm 1: Q-UrolArm 2: Placebo
Impact on Serum Biomarkers of Inflammation - Erythrocyte Sedimentation Rate (ESR)4.50 ± 1.732.50 ± 1.73
SecondaryImpact 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.

Time frame:
At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Reported as:
Mean · mg/dL
Impact on Serum Biomarkers of Inflammation - C-reactive Protein
mg/dLArm 1: Q-UrolArm 2: Placebo
Impact on Serum Biomarkers of Inflammation - C-reactive Protein0.14 ± 0.110.48 ± 0.62
SecondaryImpact 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.

Time frame:
At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Reported as:
Mean · ng/ml
Impact on Serum Biomarkers of Inflammation - Prostate-specific Antigen (PSA)
ng/mlArm 1: Q-UrolArm 2: Placebo
Impact on Serum Biomarkers of Inflammation - Prostate-specific Antigen (PSA)1.11 ± 0.901.87 ± 0.92
SecondaryAdverse 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.

Time frame:
up to 10.5 weeks after initiation of study treatment
Reported as:
Count of participants · Participants
Adverse Events by Grade
ParticipantsArm 1: Q-UrolArm 2: Placebo
Grade 1-255
Grade 3-400
Grade 500
SecondaryDays 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.

Time frame:
up to 28 days after initiation of study treatment
Reported as:
Mean · Pain Medication days
Days of Pain Medication
Pain Medication daysArm 1: Q-UrolArm 2: Placebo
Days of Pain Medication6.00 ± 6.755.20 ± 6.30

Adverse events

Collected over The collection of adverse events, serious adverse event, and survival began after the study drug was started and ended 30 days after the last dose study drug (or until new cancer treatment was initiated), up to 13 weeks after treatment initiation.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1: Q-Urol0/5 (0%)0/5 (0%)5/5 (100%)
Arm 2: Placebo0/5 (0%)0/5 (0%)5/5 (100%)
Most frequent other events
Showing 10 of 60
Most frequent other events
EventArm 1: Q-UrolArm 2: Placebo
ConstipationGastrointestinal disorders4/50/5
AnemiaBlood and lymphatic system disorders3/53/5
Dry mouthGastrointestinal disorders3/52/5
NauseaGastrointestinal disorders3/52/5
Dermatitis radiationInjury, poisoning and procedural complications1/52/5
DiarrheaGastrointestinal disorders2/50/5
DysgeusiaNervous system disorders2/50/5
DysphagiaGastrointestinal disorders2/50/5
FatigueGeneral disorders2/51/5
Gastrointestinal disorders - Other, specifyGastrointestinal disorders2/51/5

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Arm 1: Q-UrolArm 2: PlaceboTotal
<=18 years000
Between 18 and 65 years426
>=65 years134
Age, Continuous
Age, Continuous(years)Arm 1: Q-UrolArm 2: PlaceboTotal
Mean62.60 ± 6.8864.00 ± 7.8163.30 ± 6.98
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1: Q-UrolArm 2: PlaceboTotal
Female000
Male5510
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm 1: Q-UrolArm 2: PlaceboTotal
Hispanic or Latino000
Not Hispanic or Latino5510
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm 1: Q-UrolArm 2: PlaceboTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American011
White549
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Arm 1: Q-UrolArm 2: PlaceboTotal
United States5510
08

Study locations

2 sites
  • Huntsman Cancer Institute at University of Utah
    Salt Lake City, Utah 84112, United States
  • Huntsman Cancer Institute
    Salt Lake City, Utah 84112, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 11, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04252625
Lead sponsor
University of Utah
Collaborators
Farr Labs, LLC
Responsible party
Sponsor
First posted
Feb 5, 2020
Start date
Nov 14, 2022
Primary completion
Dec 27, 2023
Completion
Jan 25, 2024
Results posted
May 6, 2025
Last update
Jan 28, 2026

Study contacts

Jonathan Tward, MD, PhD
principal investigator · Huntsman Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University of Utah

Start the discussion