Lionel.D.Lewis, MD
This is randomized, double blind, placebo controlled proof of principle (window of opportunity) study of oral hydroxychloroquine in patients with resectable localized prostate cancer. To determine the effects of hydroxychloroquine (HCQ) on markers of autophagy, such as p62, LC3-II and NBR-1 in prostate cancer tissue of patients with resectable localized prostate cancer who undergo radical prostatectomy. To monitor/observe the safety and tolerability of daily oral hydroxychloroquine in the pre and perioperative period in patients who undergo radical prostatectomy. To evaluate the concentration of hydroxychloroquine in normal and prostate tumor tissue and to correlate prostate tissue concentrations with the plasma concentrations in these patients. To perform tumor genomic analysis (for common somatic mutations) and to correlate the molecular response to HCQ and presence/absence of such mutations.
Inclusion Criteria: * All patients must have pathological confirmation of adenocarcinoma of the prostate Gleason score 6 (grade Group 1) or greater. * Patients must have resectable prostate cancer as defined by the AJCC (American Joint Committee on Cancer) TNM system and have planned radical prostatectomy. * Patients must have sufficient tissue from the initial diagnostic prostate biopsy, as determined by the study pathologist, to perform the required study analyses without exhausting the tissue required for clinical purposes * Age \>18 years * Adequate hematopoietic, hepatic and renal functi…
hydroxychloroquine sulfate tablet
Inactive tablet
Arctuva estimate
Verify or correct the compensation shown for this listing.