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

Phase 2

Terminated

• Conditions: Prostate Adenocarcinoma
• Interventions: Drug: Q-Urol; Drug: Placebo

• Registration Number: NCT04252625
• Lead Sponsor: University of Utah

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.

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 Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Study Start: 2022-11-14
• Primary Completion: 2023-12-27
• Study Completion: 2024-01-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Q-Urol	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.
Arm 2: Placebo	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Sexual Health Inventory for Men (SHIM) assessment	5 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
The Rectal Function Assessment Score (R-FAS) assessment	5 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.
Impact on serum biomarkers of inflammation. Markers to include erythrocyte sedimentation rate, C-reactive protein, and prostate-specific antigen (PSA).	5 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	5 weeks	To assess safety of Q-Urol compared to placebo.
number of days medication is taken for treatment of prostate-related pain.	28 days post brachytherapy	To assess effect on prostatitis-related pain in men with localized prostate cancer following brachytherapy taking Q-Urol relative to placebo.
The Expanded Prostate Cancer Index Composite (EPIC) assessment	5 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	5 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

Trial Locations

Locations (2)

Huntsman Cancer Institute at University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States