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 - 75 mg, Glycyrrhizin - 150 mg

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

Principal Investigator

  • Natalie Reizine

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 (Dose Level 0)

PLACEBO_COMPARATOR

10 participants will be randomized to observational arm

  • OTHER:

    Observation

    Description:

    Participants will not receive glycyrrhizin

Glycyrrhizin Arm 2 (Dose Level 1)

EXPERIMENTAL

25 participants will be randomized to receive 75mg daily for 6 weeks (+/- 2 weeks)

  • DRUG:

    Glycyrrhizin - 75 mg

    Description:

    Participants will either receive 75 mg orally daily

Glycyrrhizin Arm 3 (Dose Level 2)

EXPERIMENTAL

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

  • DRUG:

    Glycyrrhizin - 150 mg

    Description:

    Participants will receive 150 mg orally daily

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Time Frame: 2 months

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

Time Frame: 2 months

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

Time Frame: 2 months

Timeline

  • Last Updated
    September 17, 2025
  • Start Date
    April 22, 2024
  • Today
    December 16, 2025
  • Completion Date ( Estimated )
    March 1, 2026

Similar Trials

light-list-check RECRUITING light-blue-people 18 - 80 Years
light-list-check RECRUITING light-blue-people 40 - 90 Years
light-list-check RECRUITING light-blue-people ≥ 18 Years