Clinical trial NCT06378346: GU-01: Glycyrrhizin in Prostate Cancer
Official title: GU-01: Glycyrrhizin in Prostate Cancer: a Window-of-Opportunity Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Detailed description: This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer who are candidates for surgery (radical prostatectomy) will receive one cycle of therapy consisting of Glycyrrhizin (GLY) (Observation, Dose Level 1 75mg daily, or Dose Level 2, 150mg daily) for 6 weeks (+/- 2 weeks) prior to surgery.

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.

Primary outcomes:
measure: Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration
timeFrame: 2 months
measure: Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy
timeFrame: 2 months
Secondary outcomes:
measure: The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0).
timeFrame: 2 months
measure: Assessment of plasma GLY levels after GLY administration
timeFrame: 2 months
measure: Assessment of blood sodium levels after GLY administration
timeFrame: 2 months
measure: Assessment of blood potassium after GLY administration
timeFrame: 2 months
measure: Assessment of serum creatinine after GLY administration
timeFrame: 2 months
measure: Assessment of serum testosterone levels after GLY administration
timeFrame: 2 months
measure: Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration
timeFrame: 2 months
measure: Assessment of interleukin-1β (IL-1β) after GLY administration
timeFrame: 2 months
measure: Assessment of Tumor necrosis factor α (TNFα) after GLY administration
timeFrame: 2 months
measure: Assessment of interleukin 6 (IL-6) after GLY administration
timeFrame: 2 months
measure: Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration
timeFrame: 2 months
measure: Assessment of Hepatocyte Growth Factor (HGF) after GLY
timeFrame: 2 months
measure: Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY
timeFrame: 2 months
measure: Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration
timeFrame: 2 months
measure: Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration
timeFrame: 2 months
measure: Gene expression analysis in tumor specimens obtained before administration of GLY
timeFrame: 2 months
measure: Number of patients with changes in gene expression analysis in tumor specimens obtained after administration of GLY
timeFrame: 2 months
measure: Number of patients with changes to fasting serum glucose level before GLY administration
timeFrame: 2 months
measure: Number of patients with changes to fasting serum glucose level after GLY administration
timeFrame: 2 months
measure: Number of patients with changes to fasting serum insulin level before GLY administration
timeFrame: 2 months
measure: Number of patients with changes to fasting serum insulin level after GLY administration
timeFrame: 2 months
measure: Number of patients with changes to fasting serum lipid level before GLY administration
timeFrame: 2 months
measure: Number of patients with changes to fasting serum lipid level after GLY administration
timeFrame: 2 months
measure: Number of patients with C-Reactive Protein before GLY administration
timeFrame: 2 months
measure: Number of patients with concentration of GLY in tumor specimens before GLY administration
timeFrame: 2 months
measure: Number of patients with concentration of GLY in tumor specimens after GLY administration
timeFrame: 2 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
Study officials:
References: