Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection

Nanjing University

Status: Unknown

Conditions: Prostate Neoplasm

Treatments: Procedure: Standard biopsy; Procedure: Targeted prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03572946

Biopsy Protocol v2.0 20181009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

target biopsy group

Experimental group

Description:

Targeted prostate biopsy

Treatment:

Procedure: Targeted prostate biopsy

standard biopsy group

Active Comparator group

Description:

Standard prostate biopsy

Treatment:

Procedure: Standard biopsy