Diagnostic Accuracy of 68Ga-PSMA PET/CT to identify residual Prostate Cancer Following Focal therapy with Irreversible Electroporation (NanoKnife).

Not Applicable

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12623001082695
• Lead Sponsor: St Vincent's Private Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-12
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 154

Inclusion Criteria

•Male greater or equal to 18 years and over
•Undergoing primary focal IRE (Nanoknife®) procedure
•Available mpMRI +/- PSMA PET/CT prior to focal IRE (Nanoknife®) procedure
•Planned for follow up transperineal biopsy as part of standard clinical follow up at 12-18 months post IRE (Nanoknife®)
•Willingness to give signed patient information and consent form (PISCF)

Exclusion Criteria

•Non-PSMA avid primary lesion on PSMA prior to IRE
•Unwilling to undergo PSMA PET/CT at 9-12 months
•Unwilling to undergo follow up transperineal biopsy
•Unwilling or unable to consent to participation in the study
•Contraindication to repeat PSMA PET/CT at 9-12 months follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish the diagnostic accuracy of PSMA PET/CT in detecting residual/recurrent clinically significant Prostate cancer at 12 months post focal IRE, defined as gleason score grade group 2-5 (with >1mm of pattern 4 present). [PSMA PET report<br>PSMA PET/CT results will be compared to for the determination of diagnostic accuracy with the gold standard, mpMRI 12 months after Irreversible Electroporation]