Imaging for Significant Prostate Cancer Risk Evaluation

NCT01492270 | Unknown

• 1 other identifier: 11/LO/1657
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Multi parametric MRI; Prostate HistoScanning; Transperineal prostate mapping biopsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

• Proportion of men correctly identified as having no cancer on Imaging (mp-MRI and Prostate HistoScanning)

  18 months

• Number of men correctly identified by Imaging (mp-MRI and Prostate HistoScanning) to have CLINICALLY SIGNIFICANT disease

  18 months

• Test- retest reproducibility of Prostate HistoScanning™.

  18 months

• Proportion of patients with correct disease risk stratification using MRI/US guided biopsies as determined by sensitivity and specificity

  18 months

• Number of patients with bothersome Lower Urinary tract symptoms following Transperineal Template Mapping biopsy

  18 months

Interventions

Prostate HistoScanning PROCEDURE

Advanced Ultrasound assessment of the prostate

Multi-parametric MRI PROCEDURE

Multi-sequence Magnetic resonance imaging of the prostate

Transperineal prostate mapping biopsy PROCEDURE

Needle biopsy of the perineum via the transperineal route at 5mm intervals guided by the use of ultrasound.

Image guided biopsies PROCEDURE

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

Also known as: Targeted Biopsy

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College London Hospitals: lead
• Advanced Medical Diagnostics s.a.: collaborator

Study Sites (1)

University College London Hospitals

London, London, NW1 2PG, United Kingdom

RECRUITING

Related Publications (3)

• 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.

  PMID: 30279583 DERIVED

• 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.

  PMID: 30017964 DERIVED

• 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.

  PMID: 29940251 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Image-Guided Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mark Emberton, MBBS,MD,FRCS

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucy AM Simmons, MBBS

CONTACT

0044 (0) 207 679 9092; lucy.simmons@uclh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Interventional Oncology

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 14, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 30, 2011

Record last verified: 2011-12

Locations

GB (1)