Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection
Diagnostic Efficiency With Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Transperineal Ultrasound-guided Biopsy in Biopsy-naïve Suspicious Prostate Cancer Patients: A Randomized Controlled Trial
1 other identifier
interventional
400
1 country
1
Brief Summary
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of mpMRI-targeted biopsy compared to transperineal standard biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
June 28, 2018
CompletedStudy Start
First participant enrolled
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedOctober 14, 2019
October 1, 2018
12 months
June 19, 2018
October 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Detection rates of clinically significant PCa
Clinically significant prostate cancer is considered as: biopsy Gleason score ≥3+4 or maximum cancer core length ≥5 mm.
30 days post biopsy
Secondary Outcomes (3)
Detection rates of clinically insignificant PCa
30 days post biopsy
Biopsy-related adverse events
30 days post biopsy
Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading
90 days post-biopsy
Study Arms (2)
target biopsy group
EXPERIMENTALTargeted prostate biopsy
standard biopsy group
ACTIVE COMPARATORStandard prostate biopsy
Interventions
Eligibility Criteria
You may qualify if:
- Men more than 18 years old with clinical suspicion of prostate cancer;
- Serum PSA ≤ 20 ng/ml within the previous 3 months;
- Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;
- No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
- mpMRI PI-RADS V2 score 4 or 5；
- Able to provide written informed consent.
You may not qualify if:
- Prior prostate biopsy or prostate surgery;
- Prior treatment for prostate cancer;
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
- Contraindication to prostate biopsy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, 210000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hongqian Guo, PhD
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Study Record Dates
First Submitted
June 19, 2018
First Posted
June 28, 2018
Study Start
October 9, 2018
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
October 14, 2019
Record last verified: 2018-10