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

NCT07386496 | Not Yet Recruiting

• 1 other identifier: CRE-2025.094
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

Prostate cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of men with clinically significant Prostate cancer (csPCa)

  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

  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 Outcomes (6)

• Proportion of men with csPCa detected in targeted and systematic biopsy

  When histology results available, at an expected average of 30 days post-biopsy

• Proportion of men with diagnosis of clinically insignificant prostate cancer

  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

  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)

  When histology results available, at an expected average of 30 days post-biopsy

• Proportion of men with post-biopsy adverse events within 30 days after biopsy

  30 days post biopsy

Study Arms (2)

COMBINED arm

EXPERIMENTAL

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 arm

ACTIVE COMPARATOR

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

Procedure: MRI-guided approach

Interventions

MRI+PSMA-guided approach PROCEDURE

MRI+PSMA-guided approach prostate biopsy

COMBINED arm

MRI-guided approach PROCEDURE

MRI-guided approach prostate biopsy

MRI arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

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Related Links

• Hong Kong Cancer Statistics.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Peter Ka-Fung CHIU

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Ka-Fung CHIU

CONTACT

35052625; peterchiu@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)