SmartTarget THERAPY

NCT02290561 | Unknown

• 1 other identifier: 14/0389
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess how accurately SmartTarget can direct high intensity focused ultrasound (HIFU) to a pre-defined area (cancer) in the prostate. The current standard methods for treating prostate cancer are directed to the whole gland - either surgery to remove it or radiotherapy. An alternative method is focal therapy. This is surgery that uses an energy source to ablate the cancer whilst preserving the normal healthy tissue. Prior to surgery prostate cancer can often be localised using MRI imaging and detailed prostate biopsy techniques. The difficulty is that during surgery it is very difficult to accurately locate the cancer on the live ultrasound images - to compensate surgeons will treat half or a quarter of the prostate to ensure that the cancer is treated. This may cause higher rates of side-effects. SmartTarget is an MRI to ultrasound fusion device that maps the pre-treatment MRI onto the live ultrasound during surgery. It then provides a target for the surgeons to treat during the operation. The results will measure if the area intended to treat was covered and if how accurate the treatment was by comparing the pre-treatment MRI with a 1 week post treatment scan

Conditions

Prostatic Neoplasms

Keywords

Prostatic Neoplasms; Therapeutics; Magnetic Resonance Imaging; Ultrasonography; High Intensity Focused Ultrasound; Image Fusion

Outcome Measures

Primary Outcomes (1)

• Target Ablation

  The ability of SmartTarget-directed focal HIFU therapy to ablate an intended target within the prostate, as measured by the proportion of men in whom complete ablation of the target region is achieved. Complete or incomplete ablation is determined by a comparative assessment of the pre-therapy and one week post-therapy contrast-enhanced MRIs by an expert radiologist.

  1 week post treatment

Secondary Outcomes (3)

• Accuracy

  1 week post treatment

• Length of the procedure

  intraoperative

• Quality of Life

  6 weeks and 3 months

Interventions

SmartTarget Therapy PROCEDURE

MRI to Ultrasound fusion directed HIFU

MRI DEVICE

high intensity focused ultrasound (HIFU) DEVICE

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of prostate cancer (PSA \</=15ng/ml, Gleason score \</=4+3, and radiological stage \</=T3aNoMo)
• Prostate biopsy concordant with mpMRI lesion (template transperineal or MRI-targeted biopsy only)
• Discrete lesion on mpMRI scoring 3, 4 or 5 on radiological scale of suspicion
• mpMRI carried out according to European Society of Uro-Radiology guidelines at 1.5T or 3T
• An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
• Signed informed consent

You may not qualify if:

• No lesion on mpMRI
• Bilateral lesions on mpMRI
• mpMRI undertaken over 6 months prior to visit 1
• Contralateral Gleason \>/=3+4 and/or Maximum Cancer Core Length Involvement \>/=6mm
• Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
• Prior immunosuppression or predefined immunosuppressed state
• An irreversible coagulopathy predisposing to bleeding
• Unable to undergo transrectal ultrasonography
• Previous radiation therapy to the pelvis
• Previous HIFU, cryosurgery, thermal, irreversible electroporation, radiofrequency or microwave therapy to the prostate.
• Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
• Men not fit for major surgery as assessed by a consultant anaesthetist
• Men who are unable to give informed consent

Sponsors & Collaborators

• University College, London: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Hashim U Ahmed, FRCS PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian A Donaldson, BMBS MRCS

CONTACT

0044 (0)207 679 9092; i.donaldson@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 14, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 14, 2014

Record last verified: 2014-11