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Trial Title:
Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial
NCT ID:
NCT06303622
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
MRI-USG fusion approach
Description:
MRI-USG fusion approach prostate biopsy
Arm group label:
MRUS arm
Intervention type:
Procedure
Intervention name:
Cognitive-guided approach
Description:
Cognitive-guided approach prostate biopsy
Arm group label:
COG arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
Male
Gender based:
Yes
Gender description:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Prince of Wales Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Start date:
June 1, 2024
Completion date:
March 31, 2027
Lead sponsor:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Source:
Chinese University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06303622
https://www3.ha.org.hk/cancereg/pdf/factsheet/2019/prostate_.pdf
