GU-01: Glycyrrhizin in Prostate Cancer

Prostate Cancer Clinical Trial

— GU-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06378346
• Other study ID #: 2023-077
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: University of Illinois at Chicago
• Contact: Natalie Reizine, MD
• Phone: 312-996-1581
• Email: nreizi2[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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 6 weeks (+/- 2 weeks) prior to surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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-ß-hydroxysteriod dehydrogenase-2 activity.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Glycyrrhizin
75mg orally daily

Other:
• Glycyrrhizin
150mg orally daily
• Observation
Participants will not receive any Glycyrrhizin

Locations

Country	Name	City	State
United States	University of Illinois	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration	To evaluate the anti-tumor activity of GLY as assessed by change in PSA before GLY administration	2 months
Primary	Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy	To evaluate the anti-tumor activity of GLY as assessed by change in PSA after GLY administration and prior to radical prostatectomy	2 months
Secondary	The tolerability of GLY 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
Secondary	Assessment of plasma GLY levels after GLY administration	The number of participants that have plasma GLY levels after administration of GLY	2 months
Secondary	Assessment of blood sodium levels after GLY administration	The number of participants that have sodium levels within normal limits (WNL)	2 months
Secondary	Assessment of blood potassium after GLY administration	The number of participants that have potassium levels within normal limits (WNL)	2 months
Secondary	Assessment of serum creatinine after GLY administration	The number of participants that have serum creatinine levels within normal limits (WNL)	2 months
Secondary	Assessment of serum testosterone levels after GLY administration	Change in serum testosterone levels	2 months
Secondary	Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration	Change in serum dehydroepiandrosterone sulfate (DHEA-S) levels	2 months
Secondary	Assessment of interleukin-1ß (IL-1ß) after GLY administration	Change in interleukin-1ß (IL-1ß) inflammatory marker	2 months
Secondary	Assessment of Tumor necrosis factor a (TNFa) after GLY administration	Change in Tumor necrosis factor a (TNFa) inflammatory marker	2 months
Secondary	Assessment of interleukin 6 (IL-6) after GLY administration	Change in interleukin 6 (IL-6) inflammatory marker	2 months
Secondary	Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration	Change in VEGF levels	2 months
Secondary	Assessment of Hepatocyte Growth Factor (HGF) after GLY	Change in HGF levels	2 months
Secondary	Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY	Change in IGF-1 levels	2 months
Secondary	Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration	Number of participants that have positive results per survey questionaries	2 months
Secondary	Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration	Number of participants that have positive results per survey questionaries	2 months
Secondary	Gene expression analysis in tumor specimens obtained before administration of GLY	Gene expression analysis in tumor specimens obtained before administration of GLY	2 months
Secondary	Number of patients with changes in gene expression analysis in tumor specimens obtained after administration of GLY	Gene expression analysis in tumor specimens obtained after administration of GLY	2 months