Trial · NCT04252625
Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis
NCT04252625, Phase 2, Terminated, University of Utah; results first posted 2025-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis. Trials, record NCT04252625. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04252625
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis
- NCT number
- NCT04252625
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Prostate Adenocarcinoma
- Interventions
- Q-Urol, Placebo
- First posted
- 2020-02-05
- Last updated
- 2026-01-28
- Results first posted
- 2025-05-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | 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. |
| Secondary | The Expanded Prostate Cancer Index Composite (EPIC) Assessment | up to 6 weeks after the start of study treatment | 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. |
| Secondary | The International Prostate Symptom Score (I-PSS) Assessment | up to 6 weeks after the start of study treatment | 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). |
| Secondary | The Rectal Function Assessment Score (R-FAS) Assessment | At the End of Treatment Visit, up to 8 weeks after initiation of study treatment. | 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). |
| Secondary | Sexual Health Inventory for Men (SHIM) Assessment | At the End of Treatment Visit, up to 8 weeks after initiation of study treatment. | 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. |
| Secondary | 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. | 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. |
| Secondary | Impact on Serum Biomarkers of Inflammation - C-reactive Protein | At the End of Treatment Visit, up to 8 weeks after initiation of study treatment. | 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. |
| Secondary | Impact on Serum Biomarkers of Inflammation - Prostate-specific Antigen (PSA) | At the End of Treatment Visit, up to 8 weeks after initiation of study treatment. | 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. |
| Secondary | Adverse Events by Grade | up to 10.5 weeks after initiation of study treatment | 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. |
| Secondary | Days of Pain Medication | up to 28 days after initiation of study treatment | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | up to 6 weeks after the start of study treatment | score on a scale | MEAN | |
| SECONDARY | The Expanded Prostate Cancer Index Composite (EPIC) Assessment | up to 6 weeks after the start of study treatment | score on a scale | MEAN | |
| SECONDARY | The International Prostate Symptom Score (I-PSS) Assessment | up to 6 weeks after the start of study treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Rectal Function Assessment Score (R-FAS) Assessment | At the End of Treatment Visit, up to 8 weeks after initiation of study treatment. | Score on a scale | MEAN | |
| SECONDARY | Sexual Health Inventory for Men (SHIM) Assessment | At the End of Treatment Visit, up to 8 weeks after initiation of study treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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. | mm/hour | MEAN | |
| SECONDARY | Impact on Serum Biomarkers of Inflammation - C-reactive Protein | At the End of Treatment Visit, up to 8 weeks after initiation of study treatment. | mg/dL | MEAN | |
| SECONDARY | Impact on Serum Biomarkers of Inflammation - Prostate-specific Antigen (PSA) | At the End of Treatment Visit, up to 8 weeks after initiation of study treatment. | ng/ml | MEAN | |
| SECONDARY | Adverse Events by Grade | up to 10.5 weeks after initiation of study treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Days of Pain Medication | up to 28 days after initiation of study treatment | Pain Medication days | MEAN |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Arm 1: Q-Urol | Pain Score | 4.00 | Standard Deviation 4.24 | score on a scale |
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Arm 2: Placebo | Pain Score | 5.8 | Standard Deviation 4.27 | score on a scale |
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Arm 1: Q-Urol | Urinary Symptoms Score | 6.00 | Standard Deviation 2.55 | score on a scale |
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Arm 2: Placebo | Urinary Symptoms Score | 4.60 | Standard Deviation 2.51 | score on a scale |
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Arm 1: Q-Urol | Quality of life impact Score | 4.80 | Standard Deviation 1.30 | score on a scale |
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Arm 2: Placebo | Quality of life impact Score | 5.20 | Standard Deviation 2.59 | score on a scale |
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Arm 1: Q-Urol | Pain score and urinary Score | 10 | Standard Deviation 5.24 | score on a scale |
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Arm 2: Placebo | Pain score and urinary Score | 10.4 | Standard Deviation 5.13 | score on a scale |
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Arm 1: Q-Urol | Total Score | 14.80 | Standard Deviation 6.38 | score on a scale |
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | Arm 2: Placebo | Total Score | 15.60 | Standard Deviation 7.09 | score on a scale |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Q-Urol | 5 | |
| Overall Study | STARTED | Arm 2: Placebo | 5 | |
| Overall Study | COMPLETED | Arm 1: Q-Urol | 5 | |
| Overall Study | COMPLETED | Arm 2: Placebo | 5 | |
| Overall Study | NOT COMPLETED | Arm 1: Q-Urol | 0 | |
| Overall Study | NOT COMPLETED | Arm 2: Placebo | 0 |
Source ClinicalTrials.gov
Adverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Arm 1: Q-Urol | 0 | 5 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm 2: Placebo | 1 | 5 | 1 |
| other | Allergic reaction | Immune system disorders | Arm 1: Q-Urol | 1 | 5 | 1 |
| other | Allergic reaction | Immune system disorders | Arm 2: Placebo | 0 | 5 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Arm 1: Q-Urol | 3 | 5 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Arm 2: Placebo | 3 | 5 | 3 |
| other | Anorexia | Metabolism and nutrition disorders | Arm 1: Q-Urol | 0 | 5 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Arm 2: Placebo | 1 | 5 | 2 |
| other | Anxiety | Psychiatric disorders | Arm 1: Q-Urol | 1 | 5 | 2 |
| other | Anxiety | Psychiatric disorders | Arm 2: Placebo | 0 | 5 | 0 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Q-Urol | 0 | 5 |
| Total, all-cause mortality | Arm 2: Placebo | 0 | 5 |
| Total, other adverse events | Arm 1: Q-Urol | 5 | 5 |
| Total, other adverse events | Arm 2: Placebo | 5 | 5 |
| Total, serious adverse events | Arm 1: Q-Urol | 0 | 5 |
| Total, serious adverse events | Arm 2: Placebo | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm 1: Q-Urol vs Arm 2: Placebo: deaths from any cause | Trial comparisons |
| Arm 1: Q-Urol vs Arm 2: Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04252625
GET https://conductscience.org/api/trials/v1/NCT04252625/results?page=2