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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Prostate Adenocarcinoma

In brief

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

Key facts

Study ID

NCT04252625

Run by

University of Utah

People needed

10

Starts

2022-11-14

Expected to finish

2024-01-25

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Huntsman Cancer Institute at University of Utah — Salt Lake City, Utah, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.