Clinical trial NCT02265159: Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer
Official title: Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2014-10-15
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Intensity Focused Ultrasound (HIFU).


Eligibility criteria: 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).

Primary outcomes:
measure: Oncological safety
timeFrame: 36 months
measure: Oncological safety
timeFrame: 36 months
Secondary outcomes:
measure: Biochemical failure
timeFrame: 36 months
measure: Sensitivity and specificity of MRI imaging
timeFrame: 36 months
measure: Health care costs
timeFrame: 36 months
measure: Erectile function
timeFrame: 36 months
measure: Orgasmic function
timeFrame: 36 months
measure: Sexual function
timeFrame: 36 months
measure: Erectile function
timeFrame: 36 months
measure: Continence
timeFrame: 36 months
measure: Continence
timeFrame: 36 months
measure: Lower urinary tract symptoms
timeFrame: 36 months
measure: Bowel function
timeFrame: 36 months
measure: Anxiety
timeFrame: 36 months
measure: Quality of life
timeFrame: 36 months
measure: General histological outcome
timeFrame: 36 months
measure: Secondary intervention
timeFrame: 36 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Klinik für Urologie, Universitätsspital Zürich
Study officials:
affiliation: Klinik für Urologie, Universitätsspital Zürich
name: Daniel Eberli, PD Dr. PhD
role: PRINCIPAL_INVESTIGATOR
References: