Prostate Cancer
Conditions
Brief summary
This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion.
Detailed description
This study is an international multicentre RCT to compare the csPCa detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion. This is a phase III randomised controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-USG fusion approach (MRUS arm) versus Cognitive-guided approach (COG arm). The study hypothesis is that MRUS arm is superior to COG arm in detecting csPCa. The result of this RCT would impact how MRI-guided prostate biopsies should be done in the future. If the MRI-USG fusion approach is superior to cognitive-guidance in csPCa detection, it should be the standard of practice in the future, and dedicated MRI-USG fusion equipment should be available in centres performing prostate biopsies.
Interventions
PROCEDUREMRI-USG fusion approach
MRI-USG fusion approach prostate biopsy
PROCEDURECognitive-guided approach
Cognitive-guided approach prostate biopsy
Sponsors
Chinese University of Hong Kong
Nanjing Drum Tower Hospital, China
China Medical University Hospital
Center of Postgraduate Medical Education, Poland
Kaohsiung Medical University
Tuen Mun Hospital Hong Kong
Queen Mary Hospital, Hong Kong
Stanford Cancer Institute
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 * Clinical suspicion of prostate cancer and indicated for prostate biopsy * Serum Prostate-specific antigen (PSA) \< 20 ng/mL * Digital rectal examination ≤ cT2 (organ-confined cancer) * Able to provide written informed consent * MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5
Exclusion criteria
* Prior prostate biopsy in the 2 years before screening visit * Prior diagnosis of prostate cancer * Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted) * Patient refusal for biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm | When histology results available, at an expected average of 30 days post-biopsy | MRI lesions with maximal size ≤10mm versus \>10mm |
| Proportion of men with a diagnosis of csPCa in prostate size of ≤50ml vs >50m | When histology results available, at an expected average of 30 days post-biopsy | prostate size of ≤50ml vs \>50ml |
| The proportion of men with a diagnosis of csPCa only in targeted biopsy | 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 a diagnosis of csPCa only in systemic biopsy | 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 a diagnosis of clinically insignificant PCa, | When histology results available, at an expected average of 30 days post-biopsy | ISUP grade group 1 Prostate cancer diagnosed on biopsy |
| Procedure time | During biopsy procedure | Total time of procedure |
| Pain score on a scale of 0-10 taken after biopsy | Immediately After biopsy procedure | The higher the score, the more pain |
| 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 |
Countries
Hong Kong
Contacts
CONTACTPeter Ka-Fungq CHIU, PhD
PRINCIPAL_INVESTIGATORPeter Ka-Fungq CHIU
Chinese University of Hong Kong
Outcome results
None listed