Actively Recruiting

Early Phase 1
Age: 18Years +
MALE
NCT06408298

HCQ in Resectable Localized Prostate Cancer

Led by Lionel.D.Lewis, MD · Updated on 2026-02-04

20

Participants Needed

1

Research Sites

164 weeks

Total Duration

On this page

Sponsors

L

Lionel.D.Lewis, MD

Lead Sponsor

D

Dartmouth Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

HCQ in Resectable Localized Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients 18 years or older
  • Pathological confirmation of prostate adenocarcinoma with Gleason score 6 or greater
  • Resectable prostate cancer as defined by AJCC TNM system with planned radical prostatectomy
  • Sufficient tissue available from initial prostate biopsy for study analyses
  • Adequate blood counts and organ function including Hb > 10g/dL, WBC > 3500/mm3, ANC > 1500/mm3, platelets > 100,000/mm3, liver enzymes ≤ 2 times upper limit of normal, bilirubin ≤ 1.5 times upper limit of normal, creatinine clearance or eGFR ≥ 60 mL/min
  • Medically fit for radical prostatectomy
  • If retinopathy is present, approval from a board-certified ophthalmologist
  • Provided informed consent acknowledging investigational nature of study treatment
Not Eligible

You will not qualify if you...

  • Prior radiation therapy for prostate cancer
  • Prior chemotherapy for prostate cancer
  • Gastrointestinal problems affecting oral medication or absorption (e.g., bowel resection, ischemic bowel, Crohn's disease, ulcerative colitis)
  • Serious uncontrolled medical disorders or active infections impairing study treatment
  • Significant cardiac disease including uncontrolled hypertension, unstable angina, recent myocardial infarction, serious arrhythmias, or history of Torsade de pointes
  • Dementia or altered mental status preventing consent or compliance
  • Use of disease-modifying anti-rheumatic drugs (DMARDs)
  • Known or suspected G6PD deficiency
  • Use of medications that affect autophagy such as calcitriol or chloroquine
  • Chronic use of drugs causing torsades de pointes unless discontinued appropriately
  • Poorly controlled diabetes mellitus
  • History of epilepsy
  • History of porphyria

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

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Research Team

B

Bridget M Labrie

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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