GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial
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.
Arms & 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
Outcome measures
Primary
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
Time frame: 2 months
Secondary
To evaluate the tolerability of GLY treatment administered daily prior to prostatectomy.
Time frame: 2 months
To assess of clinical laboratory and pathologic correlates in patients in relation to GLY treatment administration
Time frame: 2 months
To evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires
Time frame: 2 months
Eligibility criteria
Study locations (1)
University of Illinois
Chicago, Illinois, 60612