GU-01: Glycyrrhizin in Prostate Cancer
- Registration Number
- NCT06378346
- Lead Sponsor
- University of Illinois at Chicago
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 60
- Age ≥ 18 years of age at time of consent
- ECOG performance status of 0, 1, or 2
- Histologic diagnosis of prostate cancer
- Patient suitable for radical prostatectomy as determined by surgical team
- 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.
- Willing to use barrier contraceptive method during study intervention
- 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.
- Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 30 days of starting study treatment.
- Potent or moderate inhibitors and inducers of CYP3A4 if taken within a 1 week wash-out period
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Observational Arm 1 Glycyrrhizin 10 participants will be randomized to observational arm Observational Arm 1 Observation 10 participants will be randomized to observational arm Glycyrrhizin Arm 2 Glycyrrhizin 25 participants will be randomized to receive 75mg daily for 6 weeks (+/- 2 weeks) Glycyrrhizin Arm 3 Glycyrrhizin 25 participants will be randomized to receive 150mg daily for 6 weeks (+/- 2 weeks)
- Primary Outcome Measures
Name Time Method Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration 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 2 months To evaluate the anti-tumor activity of GLY as assessed by change in PSA after GLY administration and prior to radical prostatectomy
- Secondary Outcome Measures
Name Time Method Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration 2 months Number of participants that have positive results per survey questionaries
Gene expression analysis in tumor specimens obtained before administration of GLY 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 2 months Gene expression analysis in tumor specimens obtained after administration of GLY
Number of patients with changes to fasting serum glucose level before GLY administration 2 months Number of patients with changes to fasting serum glucose level before GLY administration
Number of patients with changes to fasting serum glucose level after GLY administration 2 months Number of patients with changes to fasting serum glucose level after GLY administration
Number of patients with changes to fasting serum insulin level before GLY administration 2 months Number of patients with changes to fasting serum insulin levelnbefore GLY administration
Number of patients with changes to fasting serum insulin level after GLY administration 2 months Number of patients with changes to fasting serum insulin level after GLY administration
Number of patients with changes to fasting serum lipid level before GLY administration 2 months Number of patients with changes to fasting serum lipid level before GLY administration
Number of patients with changes to fasting serum lipid level after GLY administration 2 months Number of patients with changes to fasting serum lipid level after GLY administration
Number of patients with C-Reactive Protein before GLY administration 2 months Number of patients with C-Reactive Protein before GLY administration
Number of patients with concentration of GLY in tumor specimens before GLY administration 2 months Number of patients with concentration of GLY in tumor specimens before GLY administration
Number of patients with concentration of GLY in tumor specimens after GLY administration 2 months Number of patients with concentration of GLY in tumor specimens after GLY administration
Assessment of interleukin 6 (IL-6) after GLY administration 2 months Change in interleukin 6 (IL-6) inflammatory marker
Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration 2 months Number of participants that have positive results per survey questionaries
The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0). 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 2 months The number of participants that have plasma GLY levels after administration of GLY
Assessment of blood sodium levels after GLY administration 2 months The number of participants that have sodium levels within normal limits (WNL)
Assessment of blood potassium after GLY administration 2 months The number of participants that have potassium levels within normal limits (WNL)
Assessment of serum creatinine after GLY administration 2 months The number of participants that have serum creatinine levels within normal limits (WNL)
Assessment of serum testosterone levels after GLY administration 2 months Change in serum testosterone levels
Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration 2 months Change in serum dehydroepiandrosterone sulfate (DHEA-S) levels
Assessment of interleukin-1β (IL-1β) after GLY administration 2 months Change in interleukin-1β (IL-1β) inflammatory marker
Assessment of Tumor necrosis factor α (TNFα) after GLY administration 2 months Change in Tumor necrosis factor α (TNFα) inflammatory marker
Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration 2 months Change in VEGF levels
Assessment of Hepatocyte Growth Factor (HGF) after GLY 2 months Change in HGF levels
Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY 2 months Change in IGF-1 levels
Trial Locations
- Locations (1)
University of Illinois
🇺🇸Chicago, Illinois, United States