Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection

Not Applicable

• Conditions: Prostate Neoplasm
• Interventions: Procedure: Targeted prostate biopsy; Procedure: Standard biopsy

• Registration Number: NCT03572946
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Detailed Description

Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa).

With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-biopsy (SB).

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of TB compared to SB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.

Study Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-06-28
• Status Verified: 2018-10
• Study Start: 2018-10-09
• Primary Completion: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 400

Inclusion Criteria

1. Men more than 18 years old with clinical suspicion of prostate cancer;
2. Serum PSA ≤ 20 ng/ml within the previous 3 months;
3. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;
4. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
5. mpMRI PI-RADS V2 score 4 or 5；
6. Able to provide written informed consent.

Exclusion Criteria

1. Prior prostate biopsy or prostate surgery;
2. Prior treatment for prostate cancer;
3. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
4. Contraindication to prostate biopsy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
target biopsy group	Targeted prostate biopsy	Targeted prostate biopsy
standard biopsy group	Standard biopsy	Standard prostate biopsy

Primary Outcome Measures

Name	Time	Method
Detection rates of clinically significant PCa	30 days post biopsy	Clinically significant prostate cancer is considered as: biopsy Gleason score ≥3+4 or maximum cancer core length ≥5 mm.

Secondary Outcome Measures

Name	Time	Method
Biopsy-related adverse events	30 days post biopsy
Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading	90 days post-biopsy	Comparing the Gleason grades (from 1-5, the bigger the worse) between biopsy and final pathology, Gleason grade is upgrading when the Gleason grade of final pathology is bigger than that of biopsy.
Detection rates of clinically insignificant PCa	30 days post biopsy	Clinically insignificant prostate cancer is considered as: biopsy Gleason score \<3+4 and maximum cancer core length \<5 mm.

Trial Locations

Locations (1)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University; 🇨🇳 Nanjing, Jiangsu, China