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

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).

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Focal Therapy Using High Intensity Focused Ultrasound

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8044
    • Recruiting
    • Klinik für Urologie, Universitätsspital Zürich
    • Contact: Daniel Eberli, PD Dr. PhD; Phone Number: +41 44 255 95 49; Email: Daniel.Eberli@usz.ch
    • Contact: Ashkan Mortezavi, Dr.; Phone Number: +41 44 255 11 11; Email: Ashkan.Mortezavi@usz.ch
    • Principal Investigator: Daniel Eberli, PD Dr. PhD
    • Sub-Investigator: Tullio Sulser, Prof.
    • Sub-Investigator: Ashkan Mortezavi, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Focal Therapy Using High Intensity Focused Ultrasound	Procedure: Focal Therapy Using High Intensity Focused Ultrasound; Other Names: Focal HIFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oncological safety	To determine the proportion of men who are free of clinically significant prostate cancer in the treated area AND are free of clinically significant prostate cancer in the untreated area 36 months after focal therapy using HIFU	36 months
Oncological safety	To determine the proportion of men who are free of any prostate cancer in the treated area AND are free of clinically significant prostate cancer in the untreated area 36 months after focal therapy using HIFU	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical failure	To analyse the rate of biochemical recurrence by measuring PSA values following focal therapy using HIFU: biochemical recurrence defined according to the Phoenix Consensus OR; by PSA velocity >1 ng/ml/year OR PSA doubling time </=3 years	36 months
Sensitivity and specificity of MRI imaging	To determine the clinical validity (area under the receiver operating characteristics curve (AUC), sensitivity, specificity, negative and positive predictive values, inter-observer variability) of; multi-parametric MR-imaging to predict presence of clinically significant prostate cancer on transperineal template prostate mapping biopsies prior to focal therapy; MR-imaging changes to predict presence of residual/recurrent clinically significant prostate cancer on biopsy	36 months
Health care costs	To determine the costs of treatment and longitudinal morbidity associated with complications at 36 months compared to other treatments of localized prostate cancer.	36 months
Erectile function	Rate of erectile dysfunction and time to return of erectile function (measured by the IIEF-15)	36 months
Orgasmic function	Rate of loss of ejaculation and orgasm (measured by the IIEF-15)	36 months
Sexual function	Rate of pain during intercourse	36 months
Erectile function	Number of men using phosphodiesterase-5 inhibitors to maintain erectile function (measured by the IIEF-15)	36 months
Continence	Rate of urinary incontinence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)	36 months
Continence	Time to return of continence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)	36 months
Lower urinary tract symptoms	Rate of lower urinary tract symptoms (as determined by IPSS scores)	36 months
Bowel function	Rate of bowel toxicity (determined by the UCLA-EPIC Bowel questionnaire )	36 months
Anxiety	Anxiety levels (measured by the Hospital Anxiety and Depression Scale and Memorial Anxiety Scale for Prostate Cancer	36 months
Quality of life	General health related quality of life (measured using FACT-P Version 4 )	36 months
General histological outcome	To determine the histological outcomes at 6, 12 and 36 months	36 months
Secondary intervention	Rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation)	36 months

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: University College, London
• Investigators: Principal Investigator: Daniel Eberli, PD Dr. PhD, Klinik für Urologie, Universitätsspital Zürich

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: September 29, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: KEK-ZH-Nr. 2013-0415