Imaging for Significant Prostate Cancer Risk Evaluation (PICTURE)

University College London Hospitals NHS Foundation Trust (UCLH)

Status: Unknown

Conditions: Prostate Cancer

Treatments: Procedure: Transperineal prostate mapping biopsy; Procedure: Prostate HistoScanning; Procedure: Multi-parametric MRI; Procedure: Image guided biopsies

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01492270

11/LO/1657

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)