A Phase 2 interventional study of Observation and Glycyrrhizin - 75 mg in Prostate Cancer, sponsored by University of Illinois at Chicago. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by University of Illinois at Chicago · Phase 2, Interventional, and Treatment
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)
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.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's planned enrollment of 60 is close to the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 participants will be randomized to observational arm
Other: Observation
25 participants will be randomized to receive 75mg daily for 5 weeks (+/- 2 weeks)
Drug: Glycyrrhizin - 75 mg
25 participants will be randomized to receive 150mg daily for 5 weeks (+/- 2 weeks)
Drug: Glycyrrhizin - 150 mg
Participants will not receive glycyrrhizin
Participants will either receive 75 mg orally daily
Participants will receive 150 mg orally daily
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
Time frame: 2 months
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.
Time frame: 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
Time frame: 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
Time frame: 2 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of Illinois at Chicago