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

This is an interventional treatment trial for Prostate Adenocarcinoma Read More

Inclusion Criteria:

• Male subjects aged ≥ 18 years.
• 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.
• 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 Shonberg 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.
• 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.