protocolSection identificationModule nctId: NCT06378346, orgStudyIdInfo id: 2023-077, briefTitle: GU-01: Glycyrrhizin in Prostate Cancer, acronym: GU-01, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, descriptionModule briefSummary: 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), conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Glycyrrhizin, interventions name: Glycyrrhizin, interventions name: Observation, outcomesModule primaryOutcomes measure: Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration, primaryOutcomes measure: Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy, secondaryOutcomes measure: The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0)., secondaryOutcomes measure: Assessment of plasma GLY levels after GLY administration, secondaryOutcomes measure: Assessment of blood sodium levels after GLY administration, secondaryOutcomes measure: Assessment of blood potassium after GLY administration, secondaryOutcomes measure: Assessment of serum creatinine after GLY administration, secondaryOutcomes measure: Assessment of serum testosterone levels after GLY administration, secondaryOutcomes measure: Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration, secondaryOutcomes measure: Assessment of interleukin-1β (IL-1β) after GLY administration, secondaryOutcomes measure: Assessment of Tumor necrosis factor α (TNFα) after GLY administration, secondaryOutcomes measure: Assessment of interleukin 6 (IL-6) after GLY administration, secondaryOutcomes measure: Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration, secondaryOutcomes measure: Assessment of Hepatocyte Growth Factor (HGF) after GLY, secondaryOutcomes measure: Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY, secondaryOutcomes measure: Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration, secondaryOutcomes measure: Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration, secondaryOutcomes measure: Gene expression analysis in tumor specimens obtained before administration of GLY, secondaryOutcomes measure: Number of patients with changes in gene expression analysis in tumor specimens obtained after administration of GLY, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Illinois, status: RECRUITING, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Natalie Reizine, MD, role: CONTACT, phone: 312-996-1581, email: nreizi2@uic.edu, contacts name: Omer Qazi, MBBS, role: CONTACT, phone: 312-413-1069, email: omerqazi@uic.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False