GU-01: Glycyrrhizin in Prostate Cancer

Clinicaltrials.gov ID: NCT06378346
db-list-check Status RECRUITING
b-loader Phase PHASE2
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 60

Conditions

Prostate Cancer

Drugs

Glycyrrhizin

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

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:

    Glycyrrhizin

    Description:

    150mg orally daily
  • OTHER:

    Observation

    Description:

    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:

    Glycyrrhizin

    Description:

    75mg orally daily

Glycyrrhizin Arm 3

EXPERIMENTAL

25 participants will be randomized to receive 150mg daily for 6 weeks (+/- 2 weeks)

  • DRUG:

    Glycyrrhizin

    Description:

    75mg orally daily

Outcome Measures

Primary Outcome Measures

Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration

Time Frame: 2 months

Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy

Time Frame: 2 months

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).

Time Frame: 2 months

Assessment of plasma GLY levels after GLY administration

Time Frame: 2 months

Assessment of blood sodium levels after GLY administration

Time Frame: 2 months

Assessment of blood potassium after GLY administration

Time Frame: 2 months

Assessment of serum creatinine after GLY administration

Time Frame: 2 months

Assessment of serum testosterone levels after GLY administration

Time Frame: 2 months

Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration

Time Frame: 2 months

Assessment of interleukin-1u03b2 (IL-1u03b2) after GLY administration

Time Frame: 2 months

Assessment of Tumor necrosis factor u03b1 (TNFu03b1) after GLY administration

Time Frame: 2 months

Assessment of interleukin 6 (IL-6) after GLY administration

Time Frame: 2 months

Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration

Time Frame: 2 months

Assessment of Hepatocyte Growth Factor (HGF) after GLY

Time Frame: 2 months

Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY

Time Frame: 2 months

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

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

Gene expression analysis in tumor specimens obtained before administration of GLY

Time Frame: 2 months

Number of patients with changes in gene expression analysis in tumor specimens obtained after administration of GLY

Time Frame: 2 months

Number of patients with changes to fasting serum glucose level before GLY administration

Time Frame: 2 months

Number of patients with changes to fasting serum glucose level after GLY administration

Time Frame: 2 months

Number of patients with changes to fasting serum insulin level before GLY administration

Time Frame: 2 months

Number of patients with changes to fasting serum insulin level after GLY administration

Time Frame: 2 months

Number of patients with changes to fasting serum lipid level before GLY administration

Time Frame: 2 months

Number of patients with changes to fasting serum lipid level after GLY administration

Time Frame: 2 months

Number of patients with C-Reactive Protein before GLY administration

Time Frame: 2 months

Number of patients with concentration of GLY in tumor specimens before GLY administration

Time Frame: 2 months

Number of patients with concentration of GLY in tumor specimens after GLY administration

Time Frame: 2 months

Timeline

  • Last Updated
    October 10, 2024
  • Start Date
    April 22, 2024
  • Today
    January 23, 2025
  • Completion Date ( Estimated )
    March 1, 2026

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