NCT02712684

Cancer Diagnosis by Multiparametric UltraSound of the Prostate

Multi-parametric Ultrasound Targeted Biopsies Compared to Multi-parametric MRI Targeted Biopsies in the Diagnosis of Clinically Significant Prostate Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In men who require a prostate biopsy does a multi-parametric ultrasound based diagnostic strategy compared to a multi-parametric MRI based diagnostic strategy lead to similar detection of clinically significant prostate cancer?

Detailed description

Men who require prostate biopsy will be approached and consented to enter this study. Participants will all undergo pre-biopsy mp-MRI and mp-USS of the prostate. Only men with positive scans will undergo prostate biopsy. The order in which lesions discovered on mp-MRI or on mp-USS are sampled will be randomised. All biopsies will be taken via the transperineal route in a single procedure. Comparison will be drawn between biopsy results of lesions detected by mp-USS with those lesions detected by mp-MRI. Consideration will be given as to whether a lesion detected by one imaging modality is the same abnormality as one detected by the other imaging modality, in the same patient. Analysis will be carried out at both the level of the lesion and the whole prostate. Men without suspicious lesions on either imaging modality will not proceed to biopsy.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	multiparametric MRI. Multi-parametric ultrasound	The investigators aim to test the hypothesis that multiparametric ultrasound is able to detect clinically significant prostate cancer with an accuracy that is similar to multiparametric MRI. Multi-parametric ultrasound uses different types of ultrasound images to visualise different aspects of the tissue. In other words, the standard grey-scale images shows the gross anatomy, Power Doppler and Contrast enhanced Ultrasound image blood supply (cancers have more blood supply), and Real-Time Elastography images the density of tissue (cancers are more dense).

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-05-01
• Completion: 2017-07-01
• First posted: 2016-03-18
• Last updated: 2016-08-09

Locations

1 site across 1 country: United Kingdom