Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induc… (NCT04252625) | Clinical Trial Compass
TerminatedPhase 2
Trial of Quercetin, Bromelain, Rye Flower Pollen & Papain on Reducing Severity of Radiation-Induced Prostatitis
Stopped: Drug Supply Issue
United States10 participantsStarted 2022-11-14
Plain-language summary
This study will assess the difference in prostatitis symptoms in men with localized prostate cancer following brachytherapy taking Q-Urol relative to placebo.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 treatme…
What they're measuring
1
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
Timeframe: up to 6 weeks after the start of study treatment