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Hydroxychloroquine for Resectable Localized Prostate Cancer

This study is looking at how hydroxychloroquine sulfate, a tablet, affects men with localized prostate cancer that can be removed by surgery. You would be randomly assigned to receive either hydroxychloroquine sulfate or an inactive tablet (placebo). Researchers want to see if hydroxychloroquine changes certain markers in prostate cancer tissue, like p62, LC3-II, and NBR-1 (markers of autophagy, a cell process). They will also check the safety of the drug before and during surgery, and measure how much of the drug is in your prostate tissue and blood. To join, you must be a man aged 18 or older with confirmed prostate cancer (Gleason score 6 or higher) that can be surgically removed. The study aims to enroll 20 participants.

Study design
This is a randomized, double-blind study, meaning you and your doctors won't know if you're receiving the active drug or placebo. It's a small study, planning to include 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure changes in markers of autophagy at Day 1, Day 26/27, and on the day of surgery (around day 30).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06408298

HCQ in Resectable Localized Prostate Cancer

Recruiting
EARLY_PHASE1Ages 18+InterventionalBasic science
Lionel.D.Lewis, MD
~20 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:Hydroxychloroquine Sulfate 400Mg TabPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in expression of markers of autophagy
Measured over Day 1, Day 26/27, Day of surgery(approximately day 30)

Conditions

Resectable Localized Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
New Hampshire1

Study leadership

  • Lionel Lewis, MB BCh., MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

Who to contact

Bridget M Labrie
[email protected]
16036506227
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

All patients must have pathological confirmation of adenocarcinoma of the prostate Gleason score 6 (grade Group 1) or greater.
Patients must have resectable prostate cancer as defined by the AJCC (American Joint Committee on Cancer) TNM system and have planned radical prostatectomy.
Patients must have sufficient tissue from the initial diagnostic prostate biopsy, as determined by the study pathologist, to perform the required study analyses without exhausting the tissue required for clinical purposes
Age \>18 years
Adequate hematopoietic, hepatic and renal function documented prior to study entry to include: Hb. \> 10g/dL, WBC \> 3500/mm3, ANC \> 1500/mm3 and platelets \> 100,000/mm3; hepatic transaminases (AST or ALT) ≤ 2.0 times the upper limits of normal, total bilirubin ≤ 1.5 times the upper limits of normal, estimated creatinine clearance ≥ 60 mL/min or eGFR \> 60 mL/min/1.73 m2 and normal serum cations (K+/Mg2+/Ca2+)
All patients must be medically fit candidates for radical prostatectomy.
A patient with any retinopathy will only be enrolled into the study with the approval of a board-certified ophthalmologist
All patients must give informed consent indicating they are aware of the investigational nature of this study treatment prior to any study procedures being performed.

Exclusion

Patients may not have received radiation therapy for their prostate cancer.
Patients may not have received chemotherapy for their prostate cancer.
Patients with gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, or prior major surgery or diseases which may cause malabsorption (e.g. bowel resection, ischemic bowel, Crohns or Ulcerative colitis)
A serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded.
Patients with significant cardiac disease: including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 3 months, or serious cardiac arrhythmias, including a QT interval corrected for heart rate using the Fridericia formula of ≥ 450 ms, or history of Torsade de pointes will be excluded.
Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded.
Patients receiving any disease-modifying anti-rheumatic drugs (DMARDs) will be excluded.
Patients with known or a history of G6PD deficiency will be excluded. Eligible patients will be based on clinician-investigator assessment, that the patient is not at an increased risk for G6PD deficiency (assessment should include information regarding self-reported race/ancestry), OR the patient has a negative screening test for G6PD deficiency.
Patients taking other commercially available medications which may theoretically either stimulate or inhibit autophagy (calcitriol and chloroquine) will be excluded.
Patients chronically taking drugs known to cause torsades de pointes will be excluded unless those agents can be discontinued for a period \> 6 times their half-life before study enrollment
Patients with poorly controlled diabetes mellitus will be excluded.
Patients with a history of epilepsy will be excluded.
Patients with a history of porphyria will be excluded

What this trial measures

  • Change in expression of markers of autophagyDay 1, Day 26/27, Day of surgery(approximately day 30)

    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.