NCT06378346 GU-01: Glycyrrhizin in Prostate Cancer
| NCT ID | NCT06378346 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Illinois at Chicago |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-25 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-07-25 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Natalie Reizine
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT06378346 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06378346 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06378346 currently recruiting?
Yes, NCT06378346 is actively recruiting participants. Contact the research team at nreizi2@uic.edu for enrollment information.
Where is the NCT06378346 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06378346 clinical trial?
NCT06378346 is sponsored by University of Illinois at Chicago. The principal investigator is Natalie Reizine at University of Illinois at Chicago. The trial plans to enroll 60 participants.
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