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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Klinik für Urologie, Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland
RECRUITINGOncological 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
Time frame: 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
Time frame: 36 months
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
Time frame: 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
Time frame: 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.
Time frame: 36 months
Erectile function
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Rate of erectile dysfunction and time to return of erectile function (measured by the IIEF-15)
Time frame: 36 months
Orgasmic function
Rate of loss of ejaculation and orgasm (measured by the IIEF-15)
Time frame: 36 months
Sexual function
Rate of pain during intercourse
Time frame: 36 months
Erectile function
Number of men using phosphodiesterase-5 inhibitors to maintain erectile function (measured by the IIEF-15)
Time frame: 36 months
Continence
Rate of urinary incontinence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)
Time frame: 36 months
Continence
Time to return of continence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)
Time frame: 36 months
Lower urinary tract symptoms
Rate of lower urinary tract symptoms (as determined by IPSS scores)
Time frame: 36 months
Bowel function
Rate of bowel toxicity (determined by the UCLA-EPIC Bowel questionnaire )
Time frame: 36 months
Anxiety
Anxiety levels (measured by the Hospital Anxiety and Depression Scale and Memorial Anxiety Scale for Prostate Cancer
Time frame: 36 months
Quality of life
General health related quality of life (measured using FACT-P Version 4 )
Time frame: 36 months
General histological outcome
To determine the histological outcomes at 6, 12 and 36 months
Time frame: 36 months
Secondary intervention
Rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation)
Time frame: 36 months