Prostate Cancer
Conditions
Keywords
Prostate cancer
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.
Interventions
PROCEDUREMRI+PSMA-guided approach
MRI+PSMA-guided approach prostate biopsy
PROCEDUREMRI-guided approach
MRI-guided approach prostate biopsy
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of men with additional csPCa detected only in PET targets which will affect clinical management | 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 |
| Proportion of men with clinically significant Prostate cancer (csPCa) | When histology results available, at an expected average of 30 days post-biopsy | ISUP Grade 2 or above prostate cancer diagnosed on biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| Proportion of men with post-biopsy adverse events within 30 days after biopsy | 30 days post biopsy | The severity of Adverse event is grade by Clavien-Dindo classification |
| Proportion of men with diagnosis of clinically insignificant prostate cancer | When histology results available, at an expected average of 30 days post-biopsy | ISUP grade group 1 Prostate cancer diagnosed on biopsy |
| Health-related Quality of life scores | 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: 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.) |
| Proportion of men with csPCa detected in targeted and systematic biopsy | When histology results available, at an expected average of 30 days post-biopsy | ISUP Grade 2 or above prostate cancer diagnosed on biopsy |
Countries
Hong Kong
Contacts
CONTACTPeter Ka-Fung CHIU
PRINCIPAL_INVESTIGATORPeter Ka-Fung CHIU
Chinese University of Hong Kong
Outcome results
None listed