Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection

Prostate Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03572946
• Other study ID #: Biopsy Protocol v2.0 20181009
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2018
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Hongqian Guo, PhD
• Phone: 8613605171690
• Email: dr.ghq[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Procedure:
• Targeted prostate biopsy
MRI-guided targeted prostate biopsy
• Standard biopsy
Transperineal ultrasound guided prostate biopsy(SB).

Locations

Country	Name	City	State
China	Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Detection rates of clinically insignificant PCa	Clinically insignificant prostate cancer is considered as: biopsy Gleason score <3+4 and maximum cancer core length <5 mm.	30 days post biopsy
Secondary	Biopsy-related adverse events		30 days post biopsy
Secondary	Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading	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.	90 days post-biopsy