Status:
UNKNOWN
SmartTarget THERAPY
Lead Sponsor:
University College, London
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT02290561
Start Date
December 1 2014
End Date
October 1 2015
Last Update
November 14 2014
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