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

January 27, 2026 updated by: CHIU Ka Fung Peter, Chinese University of Hong Kong

The Role of 18F-PSMA PET in Prostate Cancer Diagnosis in Equivocal MRI: a Multi-center Randomised Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators propose to conduct a phase III multi-center randomised controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-guided biopsy approach (MRI arm) versus MRI+PSMA approach (COMBINED arm). Clinically significant prostate cancer (csPCa) is defined as prostate cancer classified as ISUP (International Society of Urogenital Pathology) Grade group 2 or higher. Patients with clinical suspicion of prostate cancer on MRI with PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1) score 2 with red flag (PSA density >0.2 OR Prostate health index, PHI>35), PI-RADS 3, or PI-RADS 4 (and PSAd <0.1 OR PHI<35) will be randomised in a 1:1 manner to MRI arm or COMBINED arm. The detection rates of csPCa will be compared between arms. The study hypothesis is that COMBINED arm is superior to MRI arm in detecting csPCa and changing clinical management.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men ≥18 years of age
  • Serum Prostate-specific antigen (PSA) 4-15 ng/mL, repeated at least once
  • Prostate mpMRI done within 6 months

  • MRI prostate with PI-RADS (11) scores of:

    • PI-RADS score 2 with red flag (PSA density >0.2 OR Prostate health index, PHI>35),
    • PI-RADS 3, OR
    • PI-RADS 4 with lower csPCa risks (PSAd <0.1 OR PHI<35)
  • Normal Digital rectal examination
  • Patient agrees for targeted and systematic prostate biopsy

Exclusion Criteria:

  • Prostate biopsy within past 5 years
  • Past or current history of prostate cancer
  • Contraindicated to undergo PSMA PET-CT scan
  • Contraindicated to prostate biopsy: active urinary tract infection, fail insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (keep aspirin before and after biopsy is permitted)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COMBINED arm
In the COMBINED arm, additional pelvis-only 18F-PSMA-1007 PET-CT is performed within 6 months from mpMRI and before biopsy. Nuclear Medicine specialist interpreting PET-CT is blinded to clinical or MRI information.
Procedure: MRI+PSMA-guided approach
MRI+PSMA-guided approach prostate biopsy
Active Comparator: MRI arm
In the MRI arm, MRI-guided biopsy plus more than 12-core systematic biopsy will be performed.
Procedure: MRI-guided approach
MRI-guided approach prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of men with clinically significant Prostate cancer (csPCa)
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with additional csPCa detected only in PET targets which will affect clinical management
Time Frame: When histology results available, at an expected average of 30 days post-biopsy

Determined by an independent and blinded panel with 3 urologists, including:

  • a change of nerve-sparing approach if radical prostatectomy is considered,
  • consideration or extent of focal therapy (partial gland ablation) of the prostate
When histology results available, at an expected average of 30 days post-biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of men with post-biopsy adverse events within 30 days after biopsy
Time Frame: 30 days post biopsy
The severity of Adverse event is grade by Clavien-Dindo classification
30 days post biopsy
Proportion of men with csPCa detected in targeted and systematic biopsy
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with diagnosis of clinically insignificant prostate cancer
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
ISUP grade group 1 Prostate cancer diagnosed on biopsy
When histology results available, at an expected average of 30 days post-biopsy
Proportion of men in combined arm with negative PET who could avoid a biopsy
Time Frame: When PET results available, at an expected average of 7 days post-scan
When PET results available, at an expected average of 7 days post-scan
Correlation Between PET SUVmax of Targeted Lesion and Histologically Confirmed Clinically Significant Prostate Cancer (csPCa)
Time Frame: When histology results available, at an expected average of 30 days post-biopsy

This outcome will quantify the correlation between:

  1. SUVmax of the PET-identified target lesion Measurement Tool: PET/CT scanner Unit of Measure: SUVmax (unitless)
  2. Histopathologic confirmation of csPCa in the corresponding biopsy cores Measurement Tool: Histology assessment by certified pathologist Unit of Measure: Presence or absence of csPCa (ISUP Grade 2 or above prostate cancer)
When histology results available, at an expected average of 30 days post-biopsy
Health-related Quality of life scores
Time Frame: Assessed at baseline and at 30 days after intervention

Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.

This instrument includes:

  1. Five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each scored on a 5-level scale from 1 to 5, where:

    • 1 = no problems
    • 5 = extreme problems / unable to perform (Higher scores indicate worse health status.)

  2. A Visual Analogue Scale (EQ-VAS) ranging from 0 to 100, where:

    • 0 = worst imaginable health
    • 100 = best imaginable health (Higher scores indicate better overall health.)
Assessed at baseline and at 30 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Peter Ka-Fung CHIU, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2025.094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on MRI+PSMA-guided approach

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe