Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer
NCT ID: NCT02265159
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2014-05-31
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Focal Therapy Using High Intensity Focused Ultrasound
Focal Therapy Using High Intensity Focused Ultrasound
Interventions
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Focal Therapy Using High Intensity Focused Ultrasound
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Template biopsy:
* unilateral disease (Gleason ≤4+3)
* bilateral disease: presence of clinically significant cancer in both sides (Gleason ≤4+3) OR clinically insignificant disease with a burden of \>50% of biopsy cores taken on that side, OR bilateral clinically insignificant disease and \<50% of biopsy cores positive on any one side but with dominant disease burden on one side
* Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted)
* Serum PSA ≤15
* Life expectancy of ≥10 years
* Signed informed consent by patient
* An understanding of the German language sufficient to understand written and verbal information about the trial and consent process
Exclusion Criteria
* Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
* Men with an inability to tolerate a transrectal ultrasound
* Men with latex allergies as the HIFU probe is covered with a latex condom sheath prior to insertion into the back passage
* Men who have undergone prior significant rectal surgery preventing insertion of trans-rectal HIFU probe (decided on the type of surgery in individual cases)
* Men who have had previous HIFU, cryosurgery, thermal or microwave therapy to the prostate.
* Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.
* Men not fit for major surgery as assessed by a Consultant Anaesthetist
* Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
* Presence of metal implants/stents in the urethra
* Presence of prostatic calcification and cysts (on transrectal ultrasound) whose location will interfere with effective delivery of HIFU therapy
* Men with renal impairment with a glomerular filtration rate of \<35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
40 Years
99 Years
MALE
No
Sponsors
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University College, London
OTHER
University of Zurich
OTHER
Responsible Party
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Daniel Eberli
PD Dr. med. PhD
Principal Investigators
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Daniel Eberli, PD Dr. PhD
Role: PRINCIPAL_INVESTIGATOR
Klinik für Urologie, Universitätsspital Zürich
Locations
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Klinik für Urologie, Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Daniel Eberli, PD Dr. PhD
Role: primary
Ashkan Mortezavi, Dr.
Role: backup
Other Identifiers
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KEK-ZH-Nr. 2013-0415
Identifier Type: -
Identifier Source: org_study_id