Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398613
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-30
Brief Title:
Preoperative PSMA PETCT as Triage for ePLND in Patients Scheduled for RALP PrePSMA
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Preoperative PSMA PETCT as Triage for Extended Pelvic Lymph Node Dissection ePLND in Patients Scheduled for Robot-Assisted Laparoscopic Radical Prostatectomy RALP
Status:
RECRUITING
Status Verified Date:
2024-05
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:
PrePSMA
Brief Summary:
Extended pelvic lymph node dissection ePLND is considered the gold standard for nodal staging in men with prostate cancer PCa The aim of this project is to determine if preoperative prostate specific membrane antigen PSMA positron emission tomography PETcomputed tomograpy CT can safely replace ePLND as a staging method in PCa patients undergoing robot-assisted laparoscopic radical prostatectomy RALP
Detailed Description:
Eligible for the study is patients scheduled for RALP and ePLND according to current practice Patients will be randomized between RALP and ePLND Arm A and PSMA PETCT arm B If PSMA PETCT detect suspicious pelvic nodes the patient will undergo ePLND comcomitant with RALP If PSMA PETCT is negative only RALP will be performed
Primary outcome measures
Difference in biochemical recurrence BCR rate between arm A and arm B within 2 years after initiation of primary treatment BCR 02 ngml
Secondary outcome measures
Difference between Arm A and Arm B for surgical complications persistent PSA after RALP and initiation of salvage therapy
Primary outcome measures
Difference in biochemical recurrence BCR rate between arm A and arm B within 2 years after initiation of primary treatment BCR 02 ngml
Secondary outcome measures
Difference between Arm A and Arm B for surgical complications persistent PSA after RALP and initiation of salvage therapy
Study Oversight
Has Oversight DMC:
None
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?:
None