Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer

This is an interventional treatment trial for Prostate Cancer Read More

Inclusion Criteria:

• 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 Criteria:

• 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).