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

Utah System of Higher Education (USHE)

Status and phase: Terminated; Phase 2

Conditions: Prostate Adenocarcinoma

Treatments: Drug: Q-Urol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04252625

HCI129154

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Arm 1: Q-Urol

Active Comparator group

Description:

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.

Treatment:

Drug: Q-Urol

Arm 2: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo