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The Role of 18F-PSMA PET in Prostate Cancer Diagnosis in Equivocal MRI

NCT07386496 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-02-04

No results posted yet for this study

Summary

This study is a multi-center RCT to compare the clinically significant prostate cancer (csPCa) detection and/or change in clinical management in MRI guided (MRI arm) biopsy and MRI+18F-PSMA guided (Combined arm) biopsies in men with equivocal MRI prostate scans. If additional clinical value is shown by adding 18F-PSMA PET to equivocal MRI, then this should be the new standard of care.

Conditions

Interventions

PROCEDURE

MRI+PSMA-guided approach

MRI+PSMA-guided approach prostate biopsy

PROCEDURE

MRI-guided approach

MRI-guided approach prostate biopsy

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Peter Ka-Fung CHIU · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-12-31
Completion
2028-03-31

Countries

  • Hong Kong

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 NCT07386496 on ClinicalTrials.gov