PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI

PHASE3RecruitingINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

March 2, 2022

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2028

Conditions
Prostate Cancer
Interventions
DIAGNOSTIC_TEST

PSMA PET/CT

PSMA PET/CT (limited to the pelvis)

PROCEDURE

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.

PROCEDURE

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

Trial Locations (6)

2010

RECRUITING

St Vincent's Hospital, Sydney

3000

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

3084

RECRUITING

Austin Health, Melbourne

3144

RECRUITING

Cabrini Health, Melbourne

4006

RECRUITING

Royal Brisbane and Women's Hospital, Brisbane

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

All Listed Sponsors
collaborator

St Vincent's Hospital, Sydney

OTHER

lead

Peter MacCallum Cancer Centre, Australia

OTHER