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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
20
hydroxychloroquine sulfate tablet
Inactive tablet
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
RECRUITINGChange in expression of markers of autophagy
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.
Time frame: Day 1, Day 26/27, Day of surgery(approximately day 30)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To monitor/observe the safety and tolerability of daily oral hydroxychloroquine in the pre and perioperative period in patients who undergo radical prostatectomy
Time frame: Day 1 through post surgery visit(approximately day 60)
Evaluate the concentration of hydroxychloroquine
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.
Time frame: Day 1, Day 26/27, Day of surgery(approximately day 30)
Measure the tumor mutational burden
To perform tumor genomic analysis (for common somatic mutations)
Time frame: Baseline and Day of Surgery(approximately Day 30)
Correlation between tumor mutations and HCQ responses
Correlate the molecular response to HCQ and presence/absence of such mutations.
Time frame: Baseline and Day of Surgery(approximately Day 30)
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