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RecruitingInterventionalPhase 2

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

NCT ID: NCT06378346Sponsor: University of Illinois at ChicagoLast updated: 2026-02-23

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 5 weeks (+/- 2 weeks) prior to surgery.

Arms & interventions

  • OtherObservation

    Participants will not receive glycyrrhizin

  • DrugGlycyrrhizin - 75 mg

    Participants will either receive 75 mg orally daily

  • DrugGlycyrrhizin - 150 mg

    Participants will receive 150 mg orally daily

Outcome measures

Primary

  • 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

Secondary

  • 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

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

University of Illinois

Chicago, Illinois, 60612

Recruiting
Natalie Reizine, MD · Contact
Omer Qazi, MBBS · Contact
GU-01: Glycyrrhizin in Prostate Cancer | Cancerify