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

The Chinese University of Hong Kong

Status: Begins enrollment this month

Conditions: Prostate Cancer

Treatments: Procedure: MRI+PSMA-guided approach; Procedure: MRI-guided approach

Study type: Interventional

Funder types: Other

Identifiers

NCT07386496

CRE-2025.094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

COMBINED arm

Experimental group

Description:

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.

Treatment:

Procedure: MRI+PSMA-guided approach

MRI arm

Active Comparator group

Description:

In the MRI arm, MRI-guided biopsy plus more than 12-core systematic biopsy will be performed.

Treatment:

Procedure: MRI-guided approach