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

Phase 2

• Conditions: Prostate Cancer
• Interventions: Procedure: Focal Therapy Using High Intensity Focused Ultrasound

• Registration Number: NCT02265159
• Lead Sponsor: University of Zurich

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-15
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focal Therapy Using High Intensity Focused Ultrasound	Focal Therapy Using High Intensity Focused Ultrasound	-

Primary Outcome Measures

Name	Time	Method
Oncological safety	36 months	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

Secondary Outcome Measures

Name	Time	Method
Anxiety	36 months	Anxiety levels (measured by the Hospital Anxiety and Depression Scale and Memorial Anxiety Scale for Prostate Cancer
Biochemical failure	36 months	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
Health care costs	36 months	To determine the costs of treatment and longitudinal morbidity associated with complications at 36 months compared to other treatments of localized prostate cancer.
Continence	36 months	Time to return of continence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)
Lower urinary tract symptoms	36 months	Rate of lower urinary tract symptoms (as determined by IPSS scores)
Sensitivity and specificity of MRI imaging	36 months	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
Erectile function	36 months	Number of men using phosphodiesterase-5 inhibitors to maintain erectile function (measured by the IIEF-15)
Orgasmic function	36 months	Rate of loss of ejaculation and orgasm (measured by the IIEF-15)
Sexual function	36 months	Rate of pain during intercourse
Bowel function	36 months	Rate of bowel toxicity (determined by the UCLA-EPIC Bowel questionnaire )
Secondary intervention	36 months	Rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation)
Quality of life	36 months	General health related quality of life (measured using FACT-P Version 4 )
General histological outcome	36 months	To determine the histological outcomes at 6, 12 and 36 months

Trial Locations

Locations (1)

Klinik für Urologie, Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland