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

University of Zurich (UZH)

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Prostate Cancer

Treatments

Procedure: Focal Therapy Using High Intensity Focused Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT02265159

KEK-ZH-Nr. 2013-0415

Details and patient eligibility

About

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 Intensity Focused Ultrasound (HIFU).

Enrollment

100 estimated patients

Sex

Male

Ages

40 to 99 years old

Volunteers

No Healthy Volunteers

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).