None listed
Conditions
Brief summary
This is a prospective single site study evaluating the additive value of a diagnostic test (Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA PET)) in addition to and in combination with the current gold-standard reference mpMRI scan in men who have undergone Focal therapy for prostate cancer with Irreversible Electroporation (IRE) procedure. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with prostate cancer and you are scheduled to undergo a primary focal IRE (Nanoknife®) procedure as part of your cancer treatment. You should also have undergone both a PSMA PET/CT scan and an mpMRI scan prior to any surgical treatment as these images will be used for comparisons. Study details All participants who choose to enrol in this study will undergo a limited (pelvic only) 68Ga-PSMA PET/CT in addition to their standard-of-care surveillance mpMRI within 12 months of undergoing the IRE procedure to treat their cancer. The diagnostic accuracy of PSMA PET will be compared to the current gold-standard reference test of mpMRI and a biopsy (tissue sample) of any remaining tissue. It is hoped this research will determine whether adding a PSMA PET/CT scan to the current standard of care mpMRI scan is able to better detect residual/recurrent clinically significant prostate cancer. If the PSMA PET/CT scan is found to be a helpful addition to the current mpMRI scan, or is found to be more accurate in detecting prostate cancer than the mpMRI scan, a larger trial involving a greater number of patients with prostate cancer may be undertaken.
Interventions
The PET tracer, 68Ga-PSMA, is a PSMA ligand radiolabelled with Gallium-68 to enable its use for PET imaging which is intravenously injected in patients prior to the scan (289.9 to 414 MBq ). This whole process can take up to an hour to conduct. This procedure is conducted by PET Scientists/Technologists as per standard procedure at site. The patients are only discharged from clinic upon assessment of no adverse events reported.
68Ga PSMA PET/CT prior to Irreversible Electroporation will be con
The PET tracer, 68Ga-PSMA, is a PSMA ligand radiolabelled with Gallium-68 to enable its use for PET imaging which is intravenously injected in patients prior to the scan (289.9 to 414 MBq ). This whole process can take up to an hour to conduct. This procedure is conducted by PET Scientists/Technologists as per standard procedure at site. The patients are only discharged from clinic upon assessment of no adverse events reported. 68Ga PSMA PET/CT prior to Irreversible Electroporation will be conducted as per standard of care as a Medicare Benefits Schedule (MBS) item for the initial staging of intermediate to high-risk patients with prostate cancer since 1st Jul 2022 An additional scan will be conducted at 9-12 months post Irreversible Electroporation.
Sponsors
St Vincent's Private Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed