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

Study Overview
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Brief Summary
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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).

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Focal Therapy Using High Intensity Focused Ultrasound


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Focal Therapy Using High Intensity Focused Ultrasound<br> | Procedure: Focal Therapy Using High Intensity Focused Ultrasound<br> <br> * Other names: Focal HIFU;|

What is the study measuring?
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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 |