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PICTURE - Prostate Imaging (Multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound Guided Biopsy for Significant Prostate Cancer Risk Evaluation.


N/A
20 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

PICTURE - Prostate Imaging (Multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound Guided Biopsy for Significant Prostate Cancer Risk Evaluation.


Inclusion Criteria:



- Men who have undergone prior trans-rectal biopsies.

- Men undergoing further evaluation of their prostate and who are seeking
characterisation using Transperineal Template Prostate Mapping Biopsy.

Exclusion Criteria:

- Previous history of prostate cancer treatment

- Men unable to have MRI scan, or in whom artefact would reduce quality of MRI.

- Men unable to have general or regional anaesthesia

- Men unable to give informed consent

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of men who could avoid repeat biopsy as determined by the Negative predictive value and specificity of mp-MRI for Clinically significant disease.

Outcome Description:

Performance characteristics of mp-MRI for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Mark Emberton, MBBS,MD,FRCS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University College London Hospitals

Authority:

United Kingdom: National Health Service

Study ID:

11/LO/1657

NCT ID:

NCT01492270

Start Date:

December 2011

Completion Date:

July 2013

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Multi parametric MRI
  • Prostate HistoScanning
  • Transperineal prostate mapping biopsy
  • Prostatic Neoplasms

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