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

• ClinicalTrials.gov Identifier: NCT06378346
• Recruitment Status: Recruiting
• First Posted: April 22, 2024
• Last Update Posted: April 26, 2024
• Sponsor: University of Illinois at Chicago
• Information provided by (Responsible Party): Natalie Reizine, University of Illinois at Chicago

Tracking Information

• First Submitted Date: April 18, 2024
• First Posted Date: April 22, 2024
• Last Update Posted Date: April 26, 2024
• Estimated Study Start Date: May 2024
• Estimated Primary Completion Date: March 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2024)

• Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration [ Time Frame: 2 months ]
  To evaluate the anti-tumor activity of GLY as assessed by change in PSA before GLY administration
• Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy [ Time Frame: 2 months ]
  To evaluate the anti-tumor activity of GLY as assessed by change in PSA after GLY administration and prior to radical prostatectomy

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 23, 2024)

• The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0). [ Time Frame: 2 months ]
  The safety rate is calculated as the proportion of patients without Grade 2 or higher AE.
• Assessment of plasma GLY levels after GLY administration [ Time Frame: 2 months ]
  The number of participants that have plasma GLY levels after administration of GLY
• Assessment of blood sodium levels after GLY administration [ Time Frame: 2 months ]
  The number of participants that have sodium levels within normal limits (WNL)
• Assessment of blood potassium after GLY administration [ Time Frame: 2 months ]
  The number of participants that have potassium levels within normal limits (WNL)
• Assessment of serum creatinine after GLY administration [ Time Frame: 2 months ]
  The number of participants that have serum creatinine levels within normal limits (WNL)
• Assessment of serum testosterone levels after GLY administration [ Time Frame: 2 months ]
  Change in serum testosterone levels
• Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration [ Time Frame: 2 months ]
  Change in serum dehydroepiandrosterone sulfate (DHEA-S) levels
• Assessment of interleukin-1β (IL-1β) after GLY administration [ Time Frame: 2 months ]
  Change in interleukin-1β (IL-1β) inflammatory marker
• Assessment of Tumor necrosis factor α (TNFα) after GLY administration [ Time Frame: 2 months ]
  Change in Tumor necrosis factor α (TNFα) inflammatory marker
• Assessment of interleukin 6 (IL-6) after GLY administration [ Time Frame: 2 months ]
  Change in interleukin 6 (IL-6) inflammatory marker
• Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration [ Time Frame: 2 months ]
  Change in VEGF levels
• Assessment of Hepatocyte Growth Factor (HGF) after GLY [ Time Frame: 2 months ]
  Change in HGF levels
• Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY [ Time Frame: 2 months ]
  Change in IGF-1 levels
• Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration [ Time Frame: 2 months ]
  Number of participants that have positive results per survey questionaries
• Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration [ Time Frame: 2 months ]
  Number of participants that have positive results per survey questionaries
• Gene expression analysis in tumor specimens obtained before administration of GLY [ Time Frame: 2 months ]
  Gene expression analysis in tumor specimens obtained before administration of GLY
• Number of patients with changes in gene expression analysis in tumor specimens obtained after administration of GLY [ Time Frame: 2 months ]
  Gene expression analysis in tumor specimens obtained after administration of GLY

Original Secondary Outcome Measures (submitted: April 18, 2024)

• The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0). [ Time Frame: 2 months ]
  The safety rate is calculated as the proportion of patients without Grade 2 or higher AE.
• Assessment of plasma GLY levels after GLY administration [ Time Frame: 2 months ]
  The number of participants that have plasma GLY levels after administration of GLY
• Assessment of blood sodium levels after GLY administration [ Time Frame: 2 months ]
  The number of participants that have sodium levels within normal limits (WNL)
• Assessment of blood potassium after GLY administration [ Time Frame: 2 months ]
  The number of participants that have potassium levels within normal limits (WNL)
• Assessment of serum creatinine after GLY administration [ Time Frame: 2 months ]
  The number of participants that have serum creatinine levels within normal limits (WNL)
• Assessment of serum testosterone levels after GLY administration [ Time Frame: 2 months ]
  Change in serum testosterone levels
• Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration [ Time Frame: 2 months ]
  Change in serum dehydroepiandrosterone sulfate (DHEA-S) levels
• Assessment of interleukin-1β (IL-1β) after GLY administration [ Time Frame: 2 months ]
  Change in interleukin-1β (IL-1β) inflammatory marker
• Assessment of Tumor necrosis factor α (TNFα) after GLY administration [ Time Frame: 2 months ]
  Change in Tumor necrosis factor α (TNFα) inflammatory marker
• Assessment of interleukin 6 (IL-6) after GLY administration [ Time Frame: 2 months ]
  Change in interleukin 6 (IL-6) inflammatory marker
• Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration [ Time Frame: 2 months ]
  Change in VEGF levels
• Assessment of Hepatocyte Growth Factor (HGF) after GLY [ Time Frame: 2 months ]
  Change in HGF levels
• Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY [ Time Frame: 2 months ]
  Change in IGF-1 levels
• Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration [ Time Frame: 2 months ]
  Number of participants that have positive results per survey questionaries
• Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration [ Time Frame: 2 months ]
  Number of participants that have positive results per survey questionaries
• Gene expression analysis in tumor specimens obtained before administration of GLY [ Time Frame: 2 months ]
  Gene expression analysis in tumor specimens obtained before administration of GLY
• Gene expression analysis in tumor specimens obtained after administration of GLY [ Time Frame: 2 months ]
  Gene expression analysis in tumor specimens obtained after administration of GLY

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: GU-01: Glycyrrhizin in Prostate Cancer
• Official Title: GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial
• Brief 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)
• 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 6 weeks (+/- 2 weeks) prior to surgery.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• Drug: Glycyrrhizin
  75mg orally daily
• Other: Glycyrrhizin
  150mg orally daily
• Other: Observation
  Participants will not receive any Glycyrrhizin

Study Arms

• Placebo Comparator: Observational Arm 1
  10 participants will be randomized to observational arm
  Interventions:

  • Other: Glycyrrhizin
  • Other: Observation
• Experimental: Glycyrrhizin Arm 2
  25 participants will be randomized to receive 75mg daily for 6 weeks (+/- 2 weeks)
  Intervention: Drug: Glycyrrhizin
• Experimental: Glycyrrhizin Arm 3
  25 participants will be randomized to receive 150mg daily for 6 weeks (+/- 2 weeks)
  Intervention: Drug: Glycyrrhizin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 18, 2024): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2026
• Estimated Primary Completion Date: March 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Natalie Reizine, MD; 312-996-1581; nreizi2@uic.edu

Contact: Omer Qazi, MBBS; 312-413-1069; omerqazi@uic.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06378346
• Other Study ID Numbers: 2023-077
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Natalie Reizine, University of Illinois at Chicago
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Illinois at Chicago
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Illinois at Chicago
• Verification Date: April 2024