Q-Urol: Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 receiveQ-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
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- mean peak score of the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) [6 weeks post brachytherapy]
difference in prostatitis symptoms between treatment and placebo group.
Secondary Outcome Measures
- Sexual Health Inventory for Men (SHIM) assessment [6 weeks post brachytherapy]
Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment SHIM questionnaires SHIM Scores 1-7 Severe Erectile Dysfunction (ED) 8-11 Moderate ED 12-16 Mild to Moderate ED 17-21 Mild ED 22-25 No signs of ED
- Impact on serum biomarkers of inflammation. Markers to include erythrocyte sedimentation rate, C-reactive protein, and prostate-specific antigen (PSA). [6 weeks post brachytherapy]
inflammation markers will be collected pre- and post-brachytherapy for comparison between treatment and placebo groups.
- adverse events will be characterized for frequency, type ,severity [6 weeks]
To assess safety of Q-Urol compared to placebo.
- The Expanded Prostate Cancer Index Composite (EPIC) assessment [6 weeks post brachytherapy]
Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment EPIC questionnaires. Items are standardized to a 0-100 scale and are averaged to calculate a summary score or subscale score.
- The International Prostate Symptom Score (I-PSS) assessment [6 weeks post brachytherapy]
Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment I-PSS questionnaires. American Urological Association Symptom (AUA) Score Mild = 0-7 Moderate = 8-19 Severe = 20-35
- The Rectal Function Assessment Score (R-FAS) assessment [6 weeks post brachytherapy]
Health Related Quality of Life (HRQOL) will be assessed with pre- and post- treatment questionnaires. Responses to the questions are added up for a total between 0-27. Question 10 does not count toward the total score.
- number of days days medication is taken for treatement of prostate-related pain. [28 days post brachytherapy]
To assess effect on prostatitis-related pain in men with localized prostate cancer following bracytherapy taking Q-Urol relative to placebo.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male subjects aged ≥ 18 years.
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Men with histologically proven localized prostate adenocarcinoma, stage I - III (as defined by AJCC 8th edition), who have selected treatment with brachytherapy with or without external beam radiation, with or without androgen deprivation therapy.
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Fluent in speaking and reading English.
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Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
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Adequate organ function as defined as:
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Hepatic:
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Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
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aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN
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Renal:
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Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:
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Males: ((140-age)×weight[kg])/(serum creatinine [mg/dL]×72)
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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.
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Median life expectancy ≥ 5 years as calculated by the Lee and Shonberg Index (https://eprognosis.ucsf.edu/leeschonberg.php)
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Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
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Baseline AUA symptom scores > 15.
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Prior diagnosis of chronic prostatitis type II through IV.
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Subject has received systemic therapy intended for the treatment of prostatitis (including herbal supplements) ≤ 14 days of starting study treatment.
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Subject has received a fluoroquinolone antibiotic (e.g. ciprofloxacin, norfloxacin, ofloxacin levofloxacin, etc.) ≤ 3 days of starting study treatment.
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Subject is actively on anti-inflammatory medications for other medical conditions.
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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.
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History of irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, and interstitial cystitis-bladder pain syndrome (IC/BPS).
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History of symptomatic hypotension, falls, or syncope
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History of hypoglycemia.
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Actively abusing alcohol or drugs
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Subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
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Congestive heart failure
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Diabetes
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Pulmonary artery hypertension
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Any clinically significant condition that requires therapy with diuretic medications for any indication other than the management of hypertension.
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Other clinically significant disorders that would, in the opinion of the treating investigator, preclude safe study participation.
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Known prior severe hypersensitivity to investigational product or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
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Known allergy to pineapple or pineapple containing products.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | United States | 84112 |
| 2 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- University of Utah
- Farr Labs, LLC
Investigators
- Principal Investigator: Jonathan Tward, MD, PhD, Huntsman Cancer Institute/ University of Utah
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCI129154