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PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI
Sponsor: Peter MacCallum Cancer Centre, Australia
Summary
This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI
Official title: Prospective Multi-centre Randomised Trial of the Additive Diagnostic Value of PSMA PET in Men With Negative/Equivocal MRI in the Diagnosis of Significant Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
660
Start Date
2022-03-02
Completion Date
2027-08
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
PSMA PET/CT
PSMA PET/CT (limited to the pelvis)
Transperineal template prostate biopsy
Transperineal template prostate biopsies will be performed as per treating urologist's usual practice. No specific template for biopsy is prescribed for the purposes of the study. However, template sampling of the prostate is required, with a minimum of 12 cores, dependent on prostate volume. MRI will be available for any additional targeted biopsies required. Transperineal template biopsies must be labelled appropriately and sent for histopathological analysis.
Transperineal targeted prostate biopsy
If the PSMA PET/CT is normal, transperineal prostate biopsy would be omitted If the PSMA PET/CT is abnormal, transperineal prostate biopsies would be performed targeting the MRI (done prior to study) and PSMA PET/CT images
Locations (6)
St Vincent's Hospital
Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Austin Health
Melbourne, Victoria, Australia
Cabrini Health
Melbourne, Victoria, Australia