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NCT Number: NCT06378346

GU-01: Glycyrrhizin in Prostate Cancer

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)

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

observation

Other

Participants will not receive glycyrrhizin

Glycyrrhizin - 75 mg

Drug

Participants will either receive 75 mg orally daily

Glycyrrhizin - 150 mg

Drug

Participants will receive 150 mg orally daily

Primary outcomes

  1. To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy

    Time frame: 2 months

    Changes in prostate specific antigen (PSA) in patients with prostate cancer will be assessed before and after administration of GLY

Secondary outcomes

  1. To evaluate the tolerability of GLY treatment administered daily prior to prostatectomy.

    Time frame: 2 months

    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.

  2. To assess of clinical laboratory and pathologic correlates in patients in relation to GLY treatment administration

    Time frame: 2 months

    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
  3. To evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires

    Time frame: 2 months

    Surveys will be administered before and after GLY treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Natalie Reizine, MD

CONTACT

[email protected]

312-996-1581

Omer Qazi, MBBS

CONTACT

[email protected]

312-413-1069

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

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

Acronym: GU-01

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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