trial of quercetin, bromelain, rye flower pollen & papain on reducing severity of radiation-induced prostatitis

Conditions: Prostate Adenocarcinoma

Summary: this study will assess the difference in prostatitis symptoms in men with localized prostate cancer following brachytherapy taking q-urol relative to placebo.

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.

Eligibility criteria:
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.