Recruiting
Phase 2

Glycyrrhizin

Sponsor:

University of Illinois at Chicago

Code:

NCT06378346

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observation

Glycyrrhizin - 75 mg

Glycyrrhizin - 150 mg

Study Details

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)

Conditions

Prostate Cancer

Study ID

NCT06378346

Start date

Jul 25, 2024

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Observational Arm 1 (Dose Level 0)

10 participants will be randomized to observational arm

experimental: Glycyrrhizin Arm 2 (Dose Level 1)

25 participants will be randomized to receive 75mg daily for 5 weeks (+/- 2 weeks)

experimental: Glycyrrhizin Arm 3 (Dose Level 2)

25 participants will be randomized to receive 150mg daily for 5 weeks (+/- 2 weeks)

Interventions

Observation

Participants will not receive glycyrrhizin

Glycyrrhizin - 75 mg

Participants will either receive 75 mg orally daily

Glycyrrhizin - 150 mg

Participants will receive 150 mg orally daily

Primary outcome measure

  • To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Locations

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-02-23.