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RECRUITING
NCT06408298
EARLY_PHASE1

HCQ in Resectable Localized Prostate Cancer

Sponsor: Lionel.D.Lewis, MD

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Placebo Controlled Proof of Principle (Window of Opportunity) Study of Hydroxychloroquine (HCQ) in Prostate Cancer Patients Undergoing Radical Prostatectomy

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-01-06

Completion Date

2029-03

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

Hydroxychloroquine Sulfate 400Mg Tab

hydroxychloroquine sulfate tablet

DRUG

Placebo

Inactive tablet

Locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States