A Supplement Containing Quercetin, Bromelain, Rye Flower Pollen, and Papain for the Reduction of Radiation-Induced Prostatitis

Inclusion Criteria

• 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
• Total Bilirubin =< 1.5 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN
• Estimated creatinine clearance >= 30 mL/min by Cockcroft-Gault formula
• Highly effective contraception for both male subjects and their female partners of childbearing potential throughout the study and 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
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria

• Baseline American Urological Association (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 principal investigator (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
• Chronic hypoglycemia requiring hospitalization
• Actively abusing alcohol or drugs
• The 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 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]5.0 grade >= 3)
• Known allergy to pineapple or pineapple containing products
• Subjects taking prohibited medications. 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