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.
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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
250
MRI+PSMA-guided approach prostate biopsy
MRI-guided approach prostate biopsy
Prince of Wales Hospital
Hong Kong, Hong Kong
Proportion of men with clinically significant Prostate cancer (csPCa)
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
Time frame: 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
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with csPCa detected in targeted and systematic biopsy
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with diagnosis of clinically insignificant prostate cancer
ISUP grade group 1 Prostate cancer diagnosed on biopsy
Time frame: 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
Correlation Between PET SUVmax of Targeted Lesion and Histologically Confirmed Clinically Significant Prostate Cancer (csPCa)
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)
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Time frame: 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
The severity of Adverse event is grade by Clavien-Dindo classification
Time frame: 30 days post biopsy
Health-related Quality of life scores
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.)
Time frame: Assessed at baseline and at 30 days after intervention