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Glycyrrhizin Arm 2 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

Awards & highlights

GU-01 Trial 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.Check my eligibility

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.See study design

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.

GU-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

GU-01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+14 more

GU-01 Trial 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

611 Previous Clinical Trials

1,560,441 Total Patients Enrolled

10 Trials studying Prostate Cancer

1,008 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study currently accepting new participants?

"According to the information available on clinicaltrials.gov, this research investigation is presently in search of eligible subjects. The trial was initially uploaded on May 1st, 2024 and last revised on April 25th, 2024."

Answered by AI

How many individuals in total are involved as participants in this research investigation?

"Affirmative. Information available on clinicaltrials.gov indicates that this investigation is actively seeking participants. The trial was initially disclosed on May 1st, 2024, with the latest revision made on April 25th of the same year. Currently, the study aims to recruit 60 patients from a single designated site."

Answered by AI

Has Glycyrrhizin in the second group been given approval by the FDA?

"According to our evaluation at Power, the safety rating for Glycyrrhizin Arm 2 in this Phase 2 trial is a level 2. This signifies that while there is existing data supporting its safety profile, no evidence of efficacy has been observed yet."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"Over a 60-day period, this clinical study aims to evaluate the impact of GLY on participants' prostate-specific antigen (PSA) levels before its administration. Additional objectives involve analyzing changes in Insulin-like Growth Factor-1 (IGF-1) post-administration, monitoring plasma GLY concentrations following intake, and ensuring that participants maintain normal blood sodium levels after receiving GLY."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GU-01: Glycyrrhizin in Prostate Cancer

Natalie Reizine 2024. "GU-01: Glycyrrhizin in Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06378346.

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