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

Sponsor
Peter MacCallum Cancer Centre, Australia
Study ID
NCT05154162
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PSMA PET/CT — DIAGNOSTIC_TEST
    PSMA PET/CT (limited to the pelvis)
  • Transperineal template prostate biopsy — PROCEDURE
    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 — PROCEDURE
    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

Study Details

This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI

Key Dates

Start date
Mar 2, 2022
Status verified
Mar 2026
Primary completion
Dec 15, 2025
Completion
Aug 31, 2027

Study Design

Enrollment
660 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Experimental
    Pelvic PSMA PET ± transperineal targeted prostate biopsy
  • Other: Control
    No pelvic PSMA PET + transperineal template prostate biopsy

Primary Outcome Measure

Presence of sPCa on prostate biopsy [ Time Frame: When histology results are available, at an expected average of 14 days post-biopsy ]

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