Imaging for Significant Prostate Cancer Risk Evaluation (PICTURE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University College London Hospitals.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Advanced Medical Diagnostics s.a.
Information provided by (Responsible Party):
Professor Mark Emberton, University College London Hospitals
ClinicalTrials.gov Identifier:
NCT01492270
First received: December 6, 2011
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

The incidence of prostate cancer is rising however the number of deaths from prostate cancer is stable. Meaning the investigators are diagnosing many men with prostate cancer that will not impact on their life. The rise in incidence is mainly due to increased use of the blood test Prostate Specific Antigen (PSA), as a screening test.

Currently men suspected of having prostate cancer, identified by a raised PSA undergo trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as it is random and performed blind-the operator does not know where the cancer is. Thus many low-risk cancers that do not need treating are diagnosed and many high risk cancers are missed or incorrectly classified. So, men with a negative biopsy or those with low risk disease are usually advised to undergo another TRUS biopsy.

An imaging test is needed that could help men and their doctors decide whether the biopsy is a true reflection of what is inside his prostate.

The investigators will test the role of two imaging tests. The first, multi-parametric magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the results of these tests with a detailed biopsy map-transperineal template prostate mapping biopsy (which is currently the best way to find out what is in the prostate but requires multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone one or more TRUS biopsies and who have been advised to have further tests on as part of standard of care. They will be recruited from UCLH referral letters and clinics.

The investigators aim is to see if either of these tests can confidently rule out the presence of clinically important disease.


Condition Intervention
Prostate Cancer
Procedure: Prostate HistoScanning
Procedure: Multi-parametric MRI
Procedure: Transperineal prostate mapping biopsy
Procedure: Image guided biopsies

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PICTURE - Prostate Imaging (Multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound Guided Biopsy for Significant Prostate Cancer Risk Evaluation.

Resource links provided by NLM:


Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • Number of men who could avoid repeat biopsy as determined by the Negative predictive value and specificity of mp-MRI for Clinically significant disease. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Performance characteristics of mp-MRI for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity

  • Number of men who could avoid repeat biopsy as determined by the negative predictive value and specificity of Prostate HistoScanning for Clinically significant disease. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Performance characteristics of Prostate HistoScanning for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity


Secondary Outcome Measures:
  • Proportion of men correctly identified as having no cancer on Imaging (mp-MRI and Prostate HistoScanning) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Negative predictive value of Imaging compared to Transperineal template Mapping prostate biopsy.

  • Number of men correctly identified by Imaging (mp-MRI and Prostate HistoScanning) to have CLINICALLY SIGNIFICANT disease [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Number of men correctly identified by each test to have clinically significant disease as detected by Transperineal Template Mapping Biopsy

  • Test- retest reproducibility of Prostate HistoScanning™. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The reproducibility of Prostate HistoScanning will be assessed by looking at the predicted cancer volume and location of the HistoScanning investigation at two time points.

  • Proportion of patients with correct disease risk stratification using MRI/US guided biopsies as determined by sensitivity and specificity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Performance characteristics of MRI/US registration targeted biopsies compared to i) systematic biopsies and ii) cognitive targeted biopsies in prostate cancer risk stratification as determined by sensitivity and specificity

  • Number of patients with bothersome Lower Urinary tract symptoms following Transperineal Template Mapping biopsy [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

    Assessment of alterations in Lower Urinary tract function following Transperineal Template Mapping Biopsy

    IPSS, IPSS-QoL, Continence Function Questionnaire.


  • Number of patients with worsened erectile function compared to baseline following Transperineal Template Mapping biopsy [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

    Assesment of erectile function compared to baseline will be made using questionnairres.

    IIEF



Estimated Enrollment: 126
Study Start Date: December 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Prostate HistoScanning
    Advanced Ultrasound assessment of the prostate
    Procedure: Multi-parametric MRI
    Multi-sequence Magnetic resonance imaging of the prostate
    Procedure: Transperineal prostate mapping biopsy
    Needle biopsy of the perineum via the transperineal route at 5mm intervals guided by the use of ultrasound.
    Procedure: Image guided biopsies
    Biopsies targeted to lesions seen at a) Prostate HistoScanning and b) mp-MRI. In men with an MRI lesion further MRI/US registration biopsies will be obtained
    Other Name: Targeted Biopsy
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492270

Contacts
Contact: Lucy AM Simmons, MBBS 0044 (0) 207 679 9092 lucy.simmons@uclh.nhs.uk

Locations
United Kingdom
University College London Hospitals Recruiting
London, United Kingdom, NW1 2PG
Contact: Lucy AM Simmons, MBBS, MRCS    0044 203 447 9194    lucy.simmons@uclh.nhs.uk   
Contact: Hashim Uddin Ahmed, MBBS, MRCS    0044 203 447 9194      
Sub-Investigator: Hashim Uddin Ahmed, MBBS, MRCS         
Sub-Investigator: Caroline M Moore, MBBS,MD,FRCS         
Sponsors and Collaborators
University College London Hospitals
Advanced Medical Diagnostics s.a.
Investigators
Principal Investigator: Mark Emberton, MBBS,MD,FRCS University College London Hospitals
  More Information

No publications provided

Responsible Party: Professor Mark Emberton, Professor of Interventional Oncology, University College London Hospitals
ClinicalTrials.gov Identifier: NCT01492270     History of Changes
Other Study ID Numbers: 11/LO/1657
Study First Received: December 6, 2011
Last Updated: December 28, 2011
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University College London Hospitals:
Prostate Cancer
Multi parametric MRI
Prostate HistoScanning
Transperineal prostate mapping biopsy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 01, 2014