HCQ in Resectable Localized Prostate Cancer

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor: Lionel.D.Lewis, MD
Study ID: NCT06408298
Phase: EARLY_PHASE1
Status: Recruiting

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Conditions

Resectable Localized Prostate Cancer

Eligibility Criteria

Sex: MALE
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Hydroxychloroquine Sulfate 400Mg Tab — DRUG
hydroxychloroquine sulfate tablet
Placebo — DRUG
Inactive tablet

Study Details

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.

Key Dates

Start date: Jan 6, 2026
Status verified: Jan 2026
Primary completion: Feb 28, 2029
Completion: Mar 31, 2029

Study Design

Enrollment: 20 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Arms

Experimental: Hydroxychloroquine
Loading dose 400mg three times a day then 400mg twice daily for up to 28 days prior to surgical resection, taken orally
Placebo Comparator: Placebo
Loading dose three times a day then twice daily for up to 28 days prior to surgical resection, taken orally

Primary Outcome Measure

Change in expression of markers of autophagy [ Time Frame: Day 1, Day 26/27, Day of surgery(approximately day 30) ]

Central Contacts

Bridget M Labrie
16036506227
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	03756	Bridget Labrie [email protected] 603-650-6227 Lionel Lewis, MA., MB BCh., MD [email protected] Lionel D Lewis, MA., MB BCh., MD (PRINCIPAL_INVESTIGATOR)

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By research site

Dartmouth-Hitchcock Medical Center· Lebanon, NH