Resectable Localized Prostate CancerEarly Phase 1NCT06408298
HCQ in Resectable Localized Prostate Cancer
A Early Phase 1 study testing Hydroxychloroquine Sulfate 400Mg Tab in people with Resectable Localized Prostate Cancer, run by Lionel.D.Lewis, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Resectable Localized Prostate Cancer
- What is being tested?
- Hydroxychloroquine Sulfate 400Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to Mar 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Bridget Labrie, 603-650-6227, bridget.m.labrie@hitchcock.org
Lionel Lewis, MA., MB BCh., MD, lionel.d.lewis@dartmouth.edu
About this study
Official title: A Randomized, Placebo Controlled Proof of Principle (Window of Opportunity) Study of Hydroxychloroquine (HCQ) in Prostate Cancer Patients Undergoing Radical Prostatectomy
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
- Resectable Localized Prostate Cancer
- Being tested
- Hydroxychloroquine Sulfate 400Mg Tab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Sulfate 400Mg TabDrug
hydroxychloroquine sulfate tablet
PlaceboDrug
Inactive tablet
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Loading dose 400mg three times a day then 400mg twice daily for up to 28 days prior to surgical resection, taken orally Receives: Drug: Hydroxychloroquine Sulfate 400Mg Tab |
| Placebo | Placebo comparator | Loading dose three times a day then twice daily for up to 28 days prior to surgical resection, taken orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in expression of markers of autophagy
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.
Measured: Day 1, Day 26/27, Day of surgery(approximately day 30)
Secondary outcomes (4)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To monitor/observe the safety and tolerability of daily oral hydroxychloroquine in the pre and perioperative period in patients who undergo radical prostatectomy
Measured: Day 1 through post surgery visit(approximately day 60)
Evaluate the concentration of hydroxychloroquine
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.
Measured: Day 1, Day 26/27, Day of surgery(approximately day 30)
Measure the tumor mutational burden
To perform tumor genomic analysis (for common somatic mutations)
Measured: Baseline and Day of Surgery(approximately Day 30)
Correlation between tumor mutations and HCQ responses
Correlate the molecular response to HCQ and presence/absence of such mutations.
Measured: Baseline and Day of Surgery(approximately Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start6 Jan 2026
- Primary completionFeb 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Localized Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lionel.D.Lewis, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth Cancer Center
- Responsible party
- Sponsor-investigator, Lionel.D.Lewis, MD, Dartmouth-Hitchcock Medical Center
- Investigators
- Lionel Lewis, MB BCh., MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408298
- Sponsor's protocol ID
- 23LEW054|STUDY02002054
- Status last verified
- Jan 2026
- First submitted
- 26 Feb 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans at this time to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled Proof of Principle (Window of Opportunity) Study of Hydroxychloroquine (HCQ) in Prostate Cancer Patients Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06408298
- Acronym / sponsor ID
- 23LEW054|STUDY02002054
- Conditions
- Resectable Localized Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lionel.D.Lewis, MDUniversity, hospital or other
- Collaborators
- Dartmouth Cancer Center
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: Hydroxychloroquine Sulfate 400Mg TabLoading dose 400mg three times a day then 400mg twice daily for up to 28 days prior to surgical resection, taken orally |
| Placebo | Placebo comparator | Drug: PlaceboLoading dose three times a day then twice daily for up to 28 days prior to surgical resection, taken orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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+)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine Sulfate 400Mg Tabhydroxychloroquine sulfate tablet | Drug | Hydroxychloroquine |
| PlaceboInactive tablet | Drug | Placebo |
Primary outcome
Change in expression of markers of autophagy
Time frame: Day 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.
4 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Day 1 through post surgery visit(approximately day 60)
Evaluate the concentration of hydroxychloroquine
Time frame: Day 1, Day 26/27, Day of surgery(approximately day 30)
Measure the tumor mutational burden
Time frame: Baseline and Day of Surgery(approximately Day 30)
Correlation between tumor mutations and HCQ responses
Time frame: Baseline and Day of Surgery(approximately Day 30)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No. There are no plans at this time to share IPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lionel Lewis, MB BCh., MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hydroxychloroquine Sulfate 400Mg Tab in people with Resectable Localized Prostate Cancer, run by Lionel.D.Lewis, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bridget M Labrie (16036506227, bridget.m.labrie@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in expression of markers of autophagy (time frame: Day 1, Day 26/27, Day of surgery(approximately day 30)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.