The Role of 18F-PSMA PET in Prostate Cancer Diagnosis in Equivocal MRI: a Multi-center Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Proportion of men with clinically significant Prostate cancer (csPCa)
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: MRI+PSMA-guided approach (Procedure)
MRI arm
In the MRI arm, MRI-guided biopsy plus more than 12-core systematic biopsy will be performed.
Intervention: MRI-guided approach (Procedure)
Outcomes
Primary Outcomes
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
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
- 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)
- Health-related Quality of life scores(Assessed at baseline and at 30 days after intervention)
Investigators
CHIU Ka Fung Peter
Associate Professor
Chinese University of Hong Kong