Clinical trial · Interventional
GU-01: Glycyrrhizin in Prostate Cancer
GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial
NCT06378346CI-TRIAL-00103864GU-01recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glycyrrhizin - 150 mg | Drug | — | UNRESOLVED |
| Glycyrrhizin - 75 mg | Drug | — | UNRESOLVED |
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Observational Arm 1 (Dose Level 0)
- description
- 10 participants will be randomized to observational arm
- interventionNames
- Other: Observation
- type
- EXPERIMENTAL
- label
- Glycyrrhizin Arm 2 (Dose Level 1)
- description
- 25 participants will be randomized to receive 75mg daily for 5 weeks (+/- 2 weeks)
- interventionNames
- Drug: Glycyrrhizin - 75 mg
- type
- EXPERIMENTAL
- label
- Glycyrrhizin Arm 3 (Dose Level 2)
- description
- 25 participants will be randomized to receive 150mg daily for 5 weeks (+/- 2 weeks)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.