NCT06378346

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
10mo left

Started Jul 2024

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jul 2024Mar 2027

First Submitted

Initial submission to the registry

April 18, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

2.6 years

First QC Date

April 18, 2024

Last Update Submit

February 19, 2026

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy

    Changes in prostate specific antigen (PSA) in patients with prostate cancer will be assessed before and after administration of GLY

    2 months

Secondary Outcomes (3)

  • To evaluate the tolerability of GLY treatment administered daily prior to prostatectomy.

    2 months

  • To assess of clinical laboratory and pathologic correlates in patients in relation to GLY treatment administration

    2 months

  • To evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires

    2 months

Study Arms (3)

Observational Arm 1 (Dose Level 0)

PLACEBO COMPARATOR

10 participants will be randomized to observational arm

Other: Observation

Glycyrrhizin Arm 2 (Dose Level 1)

EXPERIMENTAL

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

Drug: Glycyrrhizin - 75 mg

Glycyrrhizin Arm 3 (Dose Level 2)

EXPERIMENTAL

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

Drug: Glycyrrhizin - 150 mg

Interventions

ObservationOTHER

Participants will not receive glycyrrhizin

Observational Arm 1 (Dose Level 0)
Glycyrrhizin - 75 mgDRUG

Participants will either receive 75 mg orally daily

Glycyrrhizin Arm 2 (Dose Level 1)
Glycyrrhizin - 150 mgDRUG

Participants will receive 150 mg orally daily

Glycyrrhizin Arm 3 (Dose Level 2)

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ObservationGlycyrrhizic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative TechniquesPentacyclic TriterpenesTriterpenesTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Natalie Reizine

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Reizine, MD

CONTACT

312-996-1581nreizi2@uic.edu

Omer Qazi, MBBS

CONTACT

312-413-1069omerqazi@uic.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 22, 2024

Study Start

July 25, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations

US(1)