← Back to searchRecruitingRecruiting
GU-01: Glycyrrhizin in Prostate Cancer
NCT06378346 · University of Illinois at Chicago
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial
About this study
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.
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 design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-07-25
Estimated completion: 2027-03
Last updated: 2026-02-23
Interventions
Other: ObservationDrug: Glycyrrhizin - 75 mgDrug: Glycyrrhizin - 150 mg
Primary outcomes
- • To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy (2 months)
Sponsor
University of Illinois at Chicago · other
Contacts & investigators
ContactNatalie Reizine, MD · contact · nreizi2@uic.edu · 312-996-1581
ContactOmer Qazi, MBBS · contact · omerqazi@uic.edu · 312-413-1069
InvestigatorNatalie Reizine · principal_investigator, University of Illinois at Chicago
All locations (1)
University of IllinoisRecruiting
Chicago, Illinois, United States