Can a Plant-Based pill soothe radiation side effects in prostate cancer?
NCT ID NCT04252625
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether a supplement called Q-Urol (made from quercetin, bromelain, rye flower pollen, and papain) could reduce prostate inflammation caused by radiation therapy in men with localized prostate cancer. Ten men who had brachytherapy (with or without other radiation or hormone therapy) were randomly assigned to take Q-Urol or a placebo for 6 weeks. The goal was to see if symptoms like pain, urinary problems, and quality of life improved. The study was stopped early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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10 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Jan 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
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Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Can a One-Two radiation punch improve prostate cancer control?
- Can a special PET scan change the course of prostate cancer?
- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?
- Can 3D imaging make prostate radiation more precise and worth the cost?
- Can surgery boost control of spread prostate cancer?