Prostate AdenocarcinomaPhase 2Q-UrolNCT04252625
Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis
A Phase 2 study testing Q-Urol in people with Prostate Adenocarcinoma, run by University of Utah at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Q-Urol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Nov 2022to 25 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: 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.
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.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Q-Urol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-UrolDrug
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.
PlaceboDrug
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 weeks after the start of study treatment
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 28 days after initiation of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start14 Nov 2022
- Primary completion27 Dec 2023
- Study completion25 Jan 2024
Why it stopped: Drug Supply Issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An asymmetric two-sided group sequential design will be used with an interim analysis for efficacy and futility.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Farr Labs, LLC
- Responsible party
- Sponsor
- Investigators
- Jonathan Tward, MD, PhD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252625
- Sponsor's protocol ID
- HCI129154
- Acronym
- Q-Urol
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2020
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04252625
- Acronym / sponsor ID
- Q-Urol / HCI129154
- Conditions
- Prostate Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug Supply Issue
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Farr Labs, LLC
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the difference in prostatitis symptoms in men with localized prostate cancer following brachytherapy taking Q-Urol relative to placebo.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- An asymmetric two-sided group sequential design will be used with an interim analysis for efficacy and futility.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Q-Urol | Active comparator | Drug: Q-UrolPatients 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. |
| Arm 2: Placebo | Placebo comparator | Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-UrolQ-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. | Drug | Arm 1: Q-Urol |
| Placeboplacebo capsule | Drug | Arm 2: Placebo |
Primary outcome
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
Time frame: up to 6 weeks after the start of study treatment
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.
9 secondary outcomes
The Expanded Prostate Cancer Index Composite (EPIC) Assessment
Time frame: up to 6 weeks after the start of study treatment
The International Prostate Symptom Score (I-PSS) Assessment
Time frame: up to 6 weeks after the start of study treatment
The Rectal Function Assessment Score (R-FAS) Assessment
Time frame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Sexual Health Inventory for Men (SHIM) Assessment
Time frame: 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)
Time frame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Impact on Serum Biomarkers of Inflammation - C-reactive Protein
Time frame: 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)
Time frame: At the End of Treatment Visit, up to 8 weeks after initiation of study treatment.
Adverse Events by Grade
Time frame: up to 10.5 weeks after initiation of study treatment
Days of Pain Medication
Time frame: up to 28 days after initiation of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Tward, MD, PhD principal investigator
Huntsman Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Q-Urol in people with Prostate Adenocarcinoma, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) (time frame: up to 6 weeks after the start of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.