Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-03-01 @ 9:34 AM
Study NCT ID:
NCT03459820
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-27
First Post:
2018-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostate Cancer Patient Management With 18F-DCFPyL PET/CT
Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Organization:
Study Overview
Official Title:
Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
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 a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.
Detailed Description:
Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a central panel of experts.
Primary endpoint:
1\. Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.
Secondary endpoints:
1. 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.
2. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.
Primary endpoint:
1\. Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.
Secondary endpoints:
1. 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.
2. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: