GU-01: Glycyrrhizin in Prostate Cancer

Launched by UNIVERSITY OF ILLINOIS AT CHICAGO · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial, called GU-01, is studying the effects of a treatment called Glycyrrhizin for men with prostate cancer who have not yet received any treatment and are planning to undergo surgery, specifically radical prostatectomy. The goal of this study is to see if Glycyrrhizin can help improve outcomes for these patients. The trial is currently recruiting male participants aged 18 and older who have been diagnosed with prostate cancer and are suitable candidates for surgery.

To participate, individuals should be in generally good health and able to provide written consent for the study. They should not have had any other cancer treatments in the past month or any other serious medical conditions that could interfere with the study. Participants will receive the study treatment for a short period before their surgery. Throughout the trial, they will be monitored closely by the medical team to ensure their safety and to collect important information about how the treatment is working. Overall, this study aims to explore a new approach to help men facing prostate cancer surgery.

Gender

MALE

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.