Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-25 @ 2:48 AM
Study NCT ID:
NCT02341404
Status:
COMPLETED
Last Update Posted:
2016-03-11
First Post:
2014-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of 2-hydroxyflutamide (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer
Sponsor:
Lidds AB
Organization:
Study Overview
Official Title:
An Open, Single Dose, Antitumour Effect Study of 2-hydroxy-flutamide as a Controlled Release Product (Liproca Depot), Injected Into the Prostate in Patients With Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2016-03
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:
The primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca Depot in patients with localized prostate cancer.
Detailed Description:
The primary aim of the study was to characterize and quantify the histopathological changes in the surgical specimens obtained in patients undergoing prostatectomy in addition to imaging changes (MRI) following a single injection of Liproca Depot in patients with localized prostate cancer.
The secondary aims ere to evaluate efficacy and safety of a single injection of Liproca Depot, and to follow the pharmacokinetic profile.
The secondary aims ere to evaluate efficacy and safety of a single injection of Liproca Depot, and to follow the pharmacokinetic profile.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: