GU-01: Glycyrrhizin in Prostate Cancer
Conditions
Prostate CancerDrugs
Glycyrrhizin - 75 mg, Glycyrrhizin - 150 mgSummary
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
- Natalie Reizine, MD
- 312-996-1581
- [email protected]
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:
ObservationDescription:
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 mgDescription:
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 mgDescription:
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
Secondary Outcome Measures
To evaluate the tolerability of GLY treatment administered daily prior to prostatectomy.
To assess of clinical laboratory and pathologic correlates in patients in relation to GLY treatment administration
To evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires
Timeline
Last Updated
September 17, 2025Start Date
April 22, 2024Today
December 16, 2025Completion Date ( Estimated )
March 1, 2026
Sponsors of this trial
Lead Sponsor
University of Illinois at Chicago