Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408298
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-02-26
Brief Title:
HCQ in Resectable Localized Prostate Cancer
Sponsor:
LionelDLewis MD
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Randomized Placebo Controlled Proof of Principle Window of Opportunity Study of Hydroxychloroquine HCQ in Prostate Cancer Patients Undergoing Radical Prostatectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 monitorobserve 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 presenceabsence of such mutations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None