RecruitingEarly Phase 1NCT06408298

HCQ in Resectable Localized Prostate Cancer

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


Sponsor

Lionel.D.Lewis, MD

Enrollment

20 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether hydroxychloroquine (HCQ) — a drug commonly used for malaria and autoimmune conditions — can be used to treat localized prostate cancer before surgery. Researchers believe it may help sensitize the tumor to make removal more effective. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with prostate cancer (Gleason grade 1 or higher) that is localized (not spread) and can be surgically removed - You have sufficient biopsy tissue available for study analysis - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your prostate cancer has spread beyond the prostate - You have a serious eye condition that could be worsened by hydroxychloroquine - You are taking medications that interact with HCQ Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHydroxychloroquine Sulfate 400Mg Tab

hydroxychloroquine sulfate tablet

DRUGPlacebo

Inactive tablet


Locations(1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

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NCT06408298