Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07386496

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRI+PSMA-guided approach

Procedure

MRI+PSMA-guided approach prostate biopsy

MRI-guided approach

Procedure

MRI-guided approach prostate biopsy

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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:

    • SUVmax of the PET-identified target lesion Measurement Tool: PET/CT scanner Unit of Measure: SUVmax (unitless)
    • 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)

  5. 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

  6. 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:

    • 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.)
    • 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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Ka-Fung CHIU

CONTACT

[email protected]

35052625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.