Imaging for Significant Prostate Cancer Risk Evaluation

Prostate Cancer Clinical Trial

— PICTURE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01492270
• Other study ID #: 11/LO/1657
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2011
• Last updated: December 28, 2011
• Start date: December 2011
• Est. completion date: July 2013

Study information

• Verified date: December 2011
• Source: University College London Hospitals
• Contact: Lucy AM Simmons, MBBS
• Phone: 0044 (0) 207 679 9092
• Email: lucy.simmons[@]uclh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Prostate HistoScanning
Advanced Ultrasound assessment of the prostate
• Multi-parametric MRI
Multi-sequence Magnetic resonance imaging of the prostate
• Transperineal prostate mapping biopsy
Needle biopsy of the perineum via the transperineal route at 5mm intervals guided by the use of ultrasound.
• 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

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals	London

Sponsors (2)

Lead Sponsor	Collaborator
University College London Hospitals	Advanced Medical Diagnostics s.a.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of men who could avoid repeat biopsy as determined by the Negative predictive value and specificity of mp-MRI for Clinically significant disease.	Performance characteristics of mp-MRI for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity	18 months	No
Primary	Number of men who could avoid repeat biopsy as determined by the negative predictive value and specificity of Prostate HistoScanning for Clinically significant disease.	Performance characteristics of Prostate HistoScanning for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity	18 months	No
Secondary	Proportion of men correctly identified as having no cancer on Imaging (mp-MRI and Prostate HistoScanning)	Negative predictive value of Imaging compared to Transperineal template Mapping prostate biopsy.	18 months	No
Secondary	Number of men correctly identified by Imaging (mp-MRI and Prostate HistoScanning) to have CLINICALLY SIGNIFICANT disease	Number of men correctly identified by each test to have clinically significant disease as detected by Transperineal Template Mapping Biopsy	18 months	No
Secondary	Test- retest reproducibility of Prostate HistoScanning™.	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.	18 months	No
Secondary	Proportion of patients with correct disease risk stratification using MRI/US guided biopsies as determined by sensitivity and specificity	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	18 months	No
Secondary	Number of patients with bothersome Lower Urinary tract symptoms following Transperineal Template Mapping biopsy	Assessment of alterations in Lower Urinary tract function following Transperineal Template Mapping Biopsy; IPSS, IPSS-QoL, Continence Function Questionnaire.	18 months	Yes
Secondary	Number of patients with worsened erectile function compared to baseline following Transperineal Template Mapping biopsy	Assesment of erectile function compared to baseline will be made using questionnairres.; IIEF	18 months	Yes