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Glycyrrhizin for Prostate Cancer (GU-01 Trial)
Phase 2
Recruiting
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years of age at time of consent
ECOG performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Summary
This trial is a small-scale study where participants with untreated prostate cancer who are eligible for surgery will receive a randomly assigned treatment before their surgery.
Who is the study for?
This trial is for men over 18 with untreated prostate cancer who are fit enough for daily activities and can undergo surgery. They must be able to give consent, release health information, and agree to use barrier contraception during the study.
What is being tested?
The study tests Glycyrrhizin (a compound from licorice root) against no treatment in men awaiting prostate surgery. Participants are randomly assigned to either receive Glycyrrhizin or just observation without any active treatment before their operation.
What are the potential side effects?
Specific side effects of Glycyrrhizin aren't detailed here, but it's generally known that high doses can cause issues like water retention, increased blood pressure, low potassium levels, and might affect hormone levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I have been diagnosed with prostate cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy
Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration
Secondary study objectives
Assessment of Hepatocyte Growth Factor (HGF) after GLY
Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY
Assessment of Tumor necrosis factor α (TNFα) after GLY administration
+23 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Glycyrrhizin Arm 3Experimental Treatment1 Intervention
25 participants will be randomized to receive 150mg daily for 6 weeks (+/- 2 weeks)
Group II: Glycyrrhizin Arm 2Experimental Treatment1 Intervention
25 participants will be randomized to receive 75mg daily for 6 weeks (+/- 2 weeks)
Group III: Observational Arm 1Placebo Group2 Interventions
10 participants will be randomized to observational arm
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,569,094 Total Patients Enrolled
10 Trials studying Prostate Cancer
1,008 Patients Enrolled for Prostate Cancer
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