Prostate Cancer
Conditions
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 5 weeks (+/- 2 weeks) prior to surgery.
Interventions
OTHERObservation
Participants will not receive glycyrrhizin
DRUGGlycyrrhizin - 75 mg
Participants will either receive 75 mg orally daily
DRUGGlycyrrhizin - 150 mg
Participants will receive 150 mg orally daily
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy | 2 months | Changes in prostate specific antigen (PSA) in patients with prostate cancer will be assessed before and after administration of GLY |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the tolerability of GLY treatment administered daily prior to prostatectomy. | 2 months | Tolerability will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0). The safety rate is calculated as the proportion of patients without Grade 2 or higher AE. |
| To assess of clinical laboratory and pathologic correlates in patients in relation to GLY treatment administration | 2 months | Clinical laboratory and pathologic correlates that will be assessed include: * Plasma GLY levels, * Blood chemistries (sodium, potassium, serum creatinine or eGFR), * Fasting serum glucose, insulin, and lipid levels, * Serum testosterone and dehydroepiandrosterone sulfate (DHEA-S) levels, * Inflammatory markers (C-Reactive Protein, interleukin-1β, Tumor necrosis factor α, and interleukin-1β), * Serum levels of growth factors (vascular endothelial growth factor, hepatocyte growth factor, Insulin-like growth factor-1, and insulin-like growth factor binding protein-3), * Gene expression analysis evaluating prostate tumor signaling pathways * Ki67, SOX2, and AR expression in tumor specimens obtained before and after administration of GLY as assessed by IHC, and * The concentration of GLY in tumor specimens |
| To evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires | 2 months | Surveys will be administered before and after GLY treatment |
Countries
United States
Contacts
CONTACTNatalie Reizine, MD
CONTACTOmer Qazi, MBBS
PRINCIPAL_INVESTIGATORNatalie Reizine
University of Illinois at Chicago
Outcome results
None listed