Clinical trial NCT01492270: Imaging for Significant Prostate Cancer Risk Evaluation
Official title: PICTURE - Prostate Imaging (Multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound Guided Biopsy for Significant Prostate Cancer Risk Evaluation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Multi parametric MRI
Prostate HistoScanning
Transperineal prostate mapping biopsy
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: Advanced Medical Diagnostics s.a.
First posted: 2011-12-14
Enrollment: 126
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
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.
timeFrame: 18 months
measure: Number of men who could avoid repeat biopsy as determined by the negative predictive value and specificity of Prostate HistoScanning for Clinically significant disease.
timeFrame: 18 months
Secondary outcomes:
measure: Proportion of men correctly identified as having no cancer on Imaging (mp-MRI and Prostate HistoScanning)
timeFrame: 18 months
measure: Number of men correctly identified by Imaging (mp-MRI and Prostate HistoScanning) to have CLINICALLY SIGNIFICANT disease
timeFrame: 18 months
measure: Test- retest reproducibility of Prostate HistoScanning™.
timeFrame: 18 months
measure: Proportion of patients with correct disease risk stratification using MRI/US guided biopsies as determined by sensitivity and specificity
timeFrame: 18 months
measure: Number of patients with bothersome Lower Urinary tract symptoms following Transperineal Template Mapping biopsy
timeFrame: 18 months
measure: Number of patients with worsened erectile function compared to baseline following Transperineal Template Mapping biopsy
timeFrame: 18 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospitals
Study officials:
affiliation: University College London Hospitals
name: Mark Emberton, MBBS,MD,FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simmons LAM, Kanthabalan A, Arya M, Briggs T, Charman SC, Freeman A, Gelister J, Jameson C, McCartan N, Moore CM, van der Muelen J, Emberton M, Ahmed HU. Prostate Imaging Compared to Transperineal Ultrasound-guided biopsy for significant prostate cancer Risk Evaluation (PICTURE): a prospective cohort validating study assessing Prostate HistoScanning. Prostate Cancer Prostatic Dis. 2019 May;22(2):261-267. doi: 10.1038/s41391-018-0094-1. Epub 2018 Oct 2.
citation: Simmons LAM, Kanthabalan A, Arya M, Briggs T, Barratt D, Charman SC, Freeman A, Hawkes D, Hu Y, Jameson C, McCartan N, Moore CM, Punwani S, van der Muelen J, Emberton M, Ahmed HU. Accuracy of Transperineal Targeted Prostate Biopsies, Visual Estimation and Image Fusion in Men Needing Repeat Biopsy in the PICTURE Trial. J Urol. 2018 Dec;200(6):1227-1234. doi: 10.1016/j.juro.2018.07.001. Epub 2018 Jul 11.
citation: Miah S, Eldred-Evans D, Simmons LAM, Shah TT, Kanthabalan A, Arya M, Winkler M, McCartan N, Freeman A, Punwani S, Moore CM, Emberton M, Ahmed HU. Patient Reported Outcome Measures for Transperineal Template Prostate Mapping Biopsies in the PICTURE Study. J Urol. 2018 Dec;200(6):1235-1240. doi: 10.1016/j.juro.2018.06.033. Epub 2018 Jun 27.