GU-01: Glycyrrhizin in Prostate Cancer
Conditions
Prostate CancerDrugs
GlycyrrhizinSummary
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.
Locations
1 location Found with status Recruiting
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.
Study Plan
Observational Arm 1
PLACEBO_COMPARATOR
10 participants will be randomized to observational arm
OTHER:
GlycyrrhizinDescription:
150mg orally dailyOTHER:
ObservationDescription:
Participants will not receive any Glycyrrhizin
Glycyrrhizin Arm 2
EXPERIMENTAL
25 participants will be randomized to receive 75mg daily for 6 weeks (+/- 2 weeks)
DRUG:
GlycyrrhizinDescription:
75mg orally daily
Glycyrrhizin Arm 3
EXPERIMENTAL
25 participants will be randomized to receive 150mg daily for 6 weeks (+/- 2 weeks)
DRUG:
GlycyrrhizinDescription:
75mg orally daily
Outcome Measures
Primary Outcome Measures
Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration
Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy
Secondary Outcome Measures
The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0).
Assessment of plasma GLY levels after GLY administration
Assessment of blood sodium levels after GLY administration
Assessment of blood potassium after GLY administration
Assessment of serum creatinine after GLY administration
Assessment of serum testosterone levels after GLY administration
Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration
Assessment of interleukin-1u03b2 (IL-1u03b2) after GLY administration
Assessment of Tumor necrosis factor u03b1 (TNFu03b1) after GLY administration
Assessment of interleukin 6 (IL-6) after GLY administration
Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration
Assessment of Hepatocyte Growth Factor (HGF) after GLY
Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY
Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration
Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration
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
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
Number of patients with changes to fasting serum insulin level before GLY administration
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
Number of patients with changes to fasting serum lipid level after GLY administration
Number of patients with C-Reactive Protein before GLY administration
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
Timeline
Last Updated
October 10, 2024Start Date
April 22, 2024Today
January 23, 2025Completion Date ( Estimated )
March 1, 2026
Sponsors of this trial
Lead Sponsor
University of Illinois at Chicago