RecruitingPhase 2NCT06378346
GU-01: Glycyrrhizin in Prostate Cancer
GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial
Sponsor
University of Illinois at Chicago
Enrollment
60 participants
Start Date
Jul 25, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria6
- Age ≥ 18 years of age at time of consent
- ECOG performance status of 0, 1, or 2
- Histologic diagnosis of prostate cancer
- Patient suitable for radical prostatectomy as determined by surgical team
- 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.
- Willing to use barrier contraceptive method during study intervention
Exclusion Criteria4
- 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.
- Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 30 days of starting study treatment.
- Potent or moderate inhibitors and inducers of CYP3A4 if taken within a 1 week wash-out period
- 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.
Interventions
OTHERObservation
Participants will not receive glycyrrhizin
DRUGGlycyrrhizin - 75 mg
Participants will either receive 75 mg orally daily
DRUGGlycyrrhizin - 150 mg
Participants will receive 150 mg orally daily
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06378346
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