Imaging for Significant Prostate Cancer Risk Evaluation (PICTURE)

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Prostate Cancer	Procedure: Prostate HistoScanning; Procedure: Multi-parametric MRI; Procedure: Transperineal prostate mapping biopsy; Procedure: Image guided biopsies	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	126 participants
Intervention Model:	Single Group Assignment
Masking:	None (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.
Study Start Date :	December 2011
Estimated Primary Completion Date :	July 2013
Estimated Study Completion Date :	July 2013

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
   Performance characteristics of mp-MRI for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity
2. 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 ]
   Performance characteristics of Prostate HistoScanning for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity

Secondary Outcome Measures :

1. Proportion of men correctly identified as having no cancer on Imaging (mp-MRI and Prostate HistoScanning) [ Time Frame: 18 months ]
   Negative predictive value of Imaging compared to Transperineal template Mapping prostate biopsy.
2. Number of men correctly identified by Imaging (mp-MRI and Prostate HistoScanning) to have CLINICALLY SIGNIFICANT disease [ Time Frame: 18 months ]
   Number of men correctly identified by each test to have clinically significant disease as detected by Transperineal Template Mapping Biopsy
3. Test- retest reproducibility of Prostate HistoScanning™. [ Time Frame: 18 months ]
   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.
4. Proportion of patients with correct disease risk stratification using MRI/US guided biopsies as determined by sensitivity and specificity [ Time Frame: 18 months ]
   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
5. Number of patients with bothersome Lower Urinary tract symptoms following Transperineal Template Mapping biopsy [ Time Frame: 18 months ]

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

   IPSS, IPSS-QoL, Continence Function Questionnaire.

6. Number of patients with worsened erectile function compared to baseline following Transperineal Template Mapping biopsy [ Time Frame: 18 months ]

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

   IIEF

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	December 14, 2011
Last Update Posted:	December 30, 2011
Last Verified:	December 2011

Keywords provided by Professor Mark Emberton, 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