SmartTarget: BIOPSY

University College London (UCL)

Status

Completed

Conditions

Prostatic Neoplasms

Diagnostic Techniques and Procedures

Treatments

Procedure: SmartTarget - Biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT02341677

14/0044

Details and patient eligibility

About

The purpose of this study is to determine how well SmartTarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer.

The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the disease location. Transperineal mapping biopsies overcome this by systematically samples the entire gland but are very intensive and time consuming to perform.

An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy can be used to inform doctors about the location of the disease. This is a difficult procedure to perform as it requires the surgeon to mentally translate the location of disease on MRI image to the live ultrasound seen in theatre.

SmartTarget may help this procedure by providing guidance to the location of the disease by fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to biopsy.

This trial will compare the outcomes of "visually directed biopsies" with those directed by SmartTarget

Enrollment

134 patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria

Previous TRUS biopsy with clinical indication for repeat biopsy
Discrete lesion on mpMRI scoring 3, 4 or 5 on PI-RADs scale
An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
Signed informed consent

Exclusion criteria

Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
Men with an irreversible coagulopathy predisposing to bleeding
Men who are unability to undergo transrectal ultrasonography
Men who have had previous radiation therapy to the pelvis
Men who have had HIFU, cryosurgery, thermal, irreversible electroporation, photodynamic, photothermal therapy, or microwave therapy to the prostate. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality is permitted
Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
Men who are unable to give informed consent