Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Location status: Recruiting
Location contact
Bridget Labrie
CONTACT
Lionel D Lewis, MA., MB BCh., MD
PRINCIPAL_INVESTIGATOR
Lionel Lewis, MA., MB BCh., MD
CONTACT
NCT Number: NCT06408298
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Early Phase 1
Lebanon, New Hampshire, 03756, United States
Location status: Recruiting
Bridget Labrie
CONTACT
Lionel D Lewis, MA., MB BCh., MD
PRINCIPAL_INVESTIGATOR
Lionel Lewis, MA., MB BCh., MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
hydroxychloroquine sulfate tablet
Inactive tablet
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.
Time frame: Day 1 through post surgery visit(approximately day 60)
To monitor/observe the safety and tolerability of daily oral hydroxychloroquine in the pre and perioperative period in patients who undergo radical prostatectomy
Time frame: Day 1, Day 26/27, Day of surgery(approximately day 30)
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.
Time frame: Baseline and Day of Surgery(approximately Day 30)
To perform tumor genomic analysis (for common somatic mutations)
Time frame: Baseline and Day of Surgery(approximately Day 30)
Correlate the molecular response to HCQ and presence/absence of such mutations.
Time frame: Baseline and Day of Surgery(approximately Day 30)
To perform exploratory analyses of the effects of HCQ on the induction of inflammation or necrosis(as measured by BNIP3 expression) in treated as compared to untreated tumors
Time frame: Baseline and Day of Surgery(approximately Day 30)
To explore the effects of hydroxychloroquine on BNIP3 expression in prostate cancer tissue
Contact information is provided by the study sponsor or research team.
Lionel.D.Lewis, MD
Other
A Randomized, Placebo Controlled Proof of Principle (Window of Opportunity) Study of Hydroxychloroquine (HCQ) in Prostate Cancer Patients Undergoing Radical Prostatectomy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.