GU-01: Glycyrrhizin in Prostate Cancer (GU-01)

GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial

This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer (PCa) who are candidates for surgery (radical prostatectomy)

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Observation; Drug: Glycyrrhizin - 75 mg; Drug: Glycyrrhizin - 150 mg

Detailed Description

This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer who are candidates for surgery (radical prostatectomy) will receive one cycle of therapy consisting of Glycyrrhizin (GLY) (Observation, Dose Level 1 75mg daily, or Dose Level 2, 150mg daily) for 5 weeks (+/- 2 weeks) prior to surgery.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Natalie Reizine, MD; Phone Number: 312-996-1581; Email: nreizi2@uic.edu
• Study Contact Backup: Name: Omer Qazi, MBBS; Phone Number: 312-413-1069; Email: omerqazi@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois
      • Contact: Natalie Reizine, MD; Phone Number: 312-996-1581; Email: nreizi2@uic.edu
      • Contact: Omer Qazi, MBBS; Phone Number: 312-413-1069; Email: omerqazi@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years of age at time of consent
2. ECOG performance status of 0, 1, or 2
3. Histologic diagnosis of prostate cancer
4. Patient suitable for radical prostatectomy as determined by surgical team
5. Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
6. Willing to use barrier contraceptive method during study intervention

Exclusion Criteria:

1. Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating urologic oncology team.
2. Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 30 days of starting study treatment.
3. Potent or moderate inhibitors and inducers of CYP3A4 if taken within a 1 week wash-out period
4. Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation, or History of Torsades de Pointes. This may include patients who have sub-optimally controlled hypertension, serum potassium levels <4.0 mEq/L, serum magnesium ≤1.8 mg/dL, prolonged gastrointestinal transit time, or decreased 11-β-hydroxysteriod dehydrogenase-2 activity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Observational Arm 1 (Dose Level 0); 10 participants will be randomized to observational arm	Other: Observation; Participants will not receive glycyrrhizin
Experimental: Glycyrrhizin Arm 2 (Dose Level 1); 25 participants will be randomized to receive 75mg daily for 5 weeks (+/- 2 weeks)	Drug: Glycyrrhizin - 75 mg; Participants will either receive 75 mg orally daily
Experimental: Glycyrrhizin Arm 3 (Dose Level 2); 25 participants will be randomized to receive 150mg daily for 5 weeks (+/- 2 weeks)	Drug: Glycyrrhizin - 150 mg; Participants will receive 150 mg orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy	Changes in prostate specific antigen (PSA) in patients with prostate cancer will be assessed before and after administration of GLY	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the tolerability of GLY treatment administered daily prior to prostatectomy.	Tolerability will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0). The safety rate is calculated as the proportion of patients without Grade 2 or higher AE.	2 months
To assess of clinical laboratory and pathologic correlates in patients in relation to GLY treatment administration	Clinical laboratory and pathologic correlates that will be assessed include: Plasma GLY levels,; Blood chemistries (sodium, potassium, serum creatinine or eGFR),; Fasting serum glucose, insulin, and lipid levels,; Serum testosterone and dehydroepiandrosterone sulfate (DHEA-S) levels,; Inflammatory markers (C-Reactive Protein, interleukin-1β, Tumor necrosis factor α, and interleukin-1β),; Serum levels of growth factors (vascular endothelial growth factor, hepatocyte growth factor, Insulin-like growth factor-1, and insulin-like growth factor binding protein-3),; Gene expression analysis evaluating prostate tumor signaling pathways; Ki67, SOX2, and AR expression in tumor specimens obtained before and after administration of GLY as assessed by IHC, and; The concentration of GLY in tumor specimens	2 months
To evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires	Surveys will be administered before and after GLY treatment	2 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Natalie Reizine, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Organic Chemicals; Investigative Techniques; Methods; Hydrocarbons; Terpenes; Pentacyclic Triterpenes; Triterpenes; Observation; Glycyrrhizic Acid
• Other Study ID Numbers: 2023-077

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No