Could a malaria drug help understand prostate cancer?
NCT ID NCT06408298
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for men with localized prostate cancer who are scheduled for surgery to remove the prostate. Participants will take hydroxychloroquine (a drug used for malaria) or a placebo daily before surgery. The goal is to see how the drug affects certain cell processes in the tumor and to check its safety. This is a small, early-phase trial focused on learning, not on treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dartmouth-Hitchcock Medical Center
RECRUITINGLebanon, New Hampshire, 03756, United States