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

NCT05154162 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2026-03-03

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

  • St Vincent's Hospital, Sydney

    collaborator OTHER

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Michael Hofman · Peter MacCallum Cancer Centre, Australia

  • Louise Emmett · St Vincent's Sydney

  • Mark Frydenberg · Cabrini Health

  • Sze-Ting Lee · Austin Health

  • Matthew Roberts · Royal Brisbane and Women's Hospital

  • Yang Du · Royal Adelaide Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2025-12-15
Completion
2027-08-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154162 on ClinicalTrials.gov