Status:
UNKNOWN
Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
University College, London
Conditions:
Prostate Cancer
Eligibility:
MALE
40-99 years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators aim to evaluate cancer control, genitourinary, rectal and overall health-related quality of life outcomes and effectiveness of focal therapy for localised prostate cancer using High ...
Eligibility Criteria
Inclusion
- Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies
- 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
- Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
- 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).
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02265159
Start Date
May 1 2014
End Date
May 1 2020
Last Update
October 27 2016
Active Locations (1)
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1
Klinik für Urologie, Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland, 8044