Trials / Unknown
UnknownNCT03572946
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Targeted prostate biopsy | MRI-guided targeted prostate biopsy |
| PROCEDURE | Standard biopsy | Transperineal ultrasound guided prostate biopsy(SB). |
Timeline
- Start date
- 2018-10-09
- Primary completion
- 2019-10-01
- Completion
- 2019-12-01
- First posted
- 2018-06-28
- Last updated
- 2019-10-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03572946. Inclusion in this directory is not an endorsement.