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Q-Urol for Prostatitis (Q-Urol Trial)
Phase 2
Waitlist Available
Led By Jonathan Tward, MD, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male subjects aged ≥ 18 years
Men with histologically proven localized prostate adenocarcinoma, stage I - III (as defined by AJCC 8th edition), who have selected treatment with brachytherapy with or without external beam radiation, with or without androgen deprivation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days post brachytherapy
Awards & highlights
Q-Urol Trial Summary
This trial will study whether Q-Urol can relieve prostatitis symptoms in men with localized prostate cancer who have undergone brachytherapy.
Who is the study for?
Men over 18 with localized prostate cancer who are fluent in English and have chosen brachytherapy. They must be relatively healthy, with good organ function and a life expectancy of at least 5 years. Participants need to use effective contraception if there's a risk of conceiving.Check my eligibility
What is being tested?
The trial is testing Q-Urol against a placebo to see if it reduces prostatitis symptoms after brachytherapy for prostate cancer. Men will either receive the actual supplement or a dummy pill without active ingredients.See study design
What are the potential side effects?
While specific side effects aren't listed, participants with allergies to pineapple or certain medical conditions were excluded, suggesting potential allergic reactions or interactions with existing health issues.
Q-Urol Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowQ-Urol Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days post brachytherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days post brachytherapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
mean peak score of the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
Secondary outcome measures
Impact on serum biomarkers of inflammation. Markers to include erythrocyte sedimentation rate, C-reactive protein, and prostate-specific antigen (PSA).
Sexual Health Inventory for Men (SHIM) assessment
The Expanded Prostate Cancer Index Composite (EPIC) assessment
+4 moreQ-Urol Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Arm 1: Q-UrolActive Control1 Intervention
Patients will be randomized in a 1:1 ratio to receive Q-Urol, two capsules, 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.
Group II: Arm 2: PlaceboPlacebo Group1 Intervention
Patients will be randomized in a 1:1 ratio to receive Placebo, two capsules, 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.
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,098 Previous Clinical Trials
1,778,490 Total Patients Enrolled
Farr Labs, LLCUNKNOWN
Jonathan Tward, MD, PhDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, or bladder pain syndrome (IC/BPS).You have had or currently have another type of cancer that could affect the evaluation of the new treatment.You have a history of low blood pressure, falling, or fainting.You have a history of low blood sugar (hypoglycemia).You are currently using alcohol or drugs in a harmful or dangerous way.You have had a very severe allergic reaction to the study drug or any of its ingredients in the past.You are allergic to pineapple or anything that has pineapple in it.Your urinary symptoms, as measured by the AUA symptom score, are more severe than a score of 15.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Placebo
- Group 2: Arm 1: Q-Urol
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being observed in this experiment?
"That is correct, the online information states that this clinical trial has open enrollment and is looking for 140 patients from 2 different locations."
Answered by AI
Can people still apply to participate in this experiment?
"The information available on clinicaltrials.gov verifies that this trial is looking for subjects as we speak. The original posting was on 6/13/2022, and there have been no updates since then. They are hoping to enroll 140 patients at 2 different hospitals."
Answered by AI
Is Arm 1: Q-Urol likely to cause any harm to patients?
"Arm 1: Q-Urol was given a safety rating of 2. While there is some data supporting safety, none of it speaks to the efficacy of this medication."
Answered by AI
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