Glycyrrhizin treatment for prostate cancer before surgery
GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial
This study is testing whether a treatment called Glycyrrhizin can help men with untreated prostate cancer feel better before their surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Illinois at Chicago Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06378346 on ClinicalTrials.gov |
What this trial studies
This pilot, randomized trial investigates the effects of Glycyrrhizin (GLY) on patients with untreated prostate cancer who are candidates for radical prostatectomy. Participants will receive one cycle of therapy with either 75mg or 150mg of Glycyrrhizin daily for six weeks prior to their surgery. The study aims to assess the safety and efficacy of this treatment approach in a window-of-opportunity setting. The trial will include a control group receiving observation to compare outcomes.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 18 and older with a histologic diagnosis of prostate cancer who are eligible for radical prostatectomy.
Not a fit: Patients with prior malignancies or those who have received recent cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and overall management of prostate cancer.
How similar studies have performed: While Glycyrrhizin has been studied in other contexts, this specific approach in prostate cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- University of Illinois — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Natalie Reizine — University of Illinois at Chicago
- Study coordinator: Natalie Reizine, MD
- Email: nreizi2@uic.edu
- Phone: 312-996-1581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.