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NCT06408298 · ClinicalTrials.gov registry record · Early Phase 1
HCQ in Resectable Localized Prostate Cancer
A Early Phase 1 study of Resectable Localized Prostate Cancer, sponsored by Lionel.D.Lewis, MD.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06408298: Recruiting Early Phase 1 study of Resectable Localized Prostate Cancer, sponsored by Lionel.D.Lewis, MD.
NCT06408298 is a Early Phase 1 study of Resectable Localized Prostate Cancer that is actively recruiting participants, run by Lionel.D.Lewis, MD. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06408298, a Early Phase 1 study of Resectable Localized Prostate Cancer, is actively recruiting participants, sponsored by Lionel.D.Lewis, MD.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Hydroxychloroquine Sulfate 400Mg Tab
Study Locations (1)
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-01-06 |
| Est. Completion | 2029-03 |
| Phase | Early Phase 1 |
What NCT06408298 shows while recruiting
NCT06408298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Resectable Localized Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06408298 reports a single indexed study location in New Hampshire.
Frequently Asked Questions
What is clinical trial NCT06408298 about?
NCT06408298 is a clinical study titled "HCQ in Resectable Localized Prostate Cancer". 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 prost...
What is the current status of trial NCT06408298?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2026-01-06. Estimated completion is 2029-03.
What conditions does trial NCT06408298 study?
This clinical trial studies the following conditions: Resectable Localized Prostate Cancer.
What interventions are being tested in trial NCT06408298?
The interventions under investigation include: Placebo (DRUG), Hydroxychloroquine Sulfate 400Mg Tab (DRUG).
Who is sponsoring clinical trial NCT06408298?
This trial is sponsored by Lionel.D.Lewis, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06408298 being conducted?
This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06408298's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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