A Multi-Center Prospective Single Arm Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound (Sonablate 500) for Localized Prostate Cancer
OBJECTIVES:
Primary
- 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 high-intensity focused ultrasound (HIFU).
- To determine the proportion of men who are free of clinically significant prostate
cancer in the treated and untreated area 36 months after focal therapy using HIFU.
Secondary
- To determine the rate of erectile dysfunction after HIFU.
- To determine the time to return of erectile function after HIFU.
- To determine the rate of urinary incontinence after HIFU.
- To determine the time to return of continence (pad-free, leak-free, and pad-free alone)
after HIFU.
- To determine the rate of loss of ejaculation after focal therapy using HIFU.
- To determine the rate of loss of orgasm.
- To determine the rate of pain during intercourse.
- To determine the rate of significant decrease in penile length after HIFU.
- To determine the number of men using phosphodiesterase-5 inhibitors to maintain
erectile function after HIFU.
- To determine the rate of lower urinary tract symptoms after HIFU.
- To determine the rate of bowel toxicity after HIFU.
- To determine the anxiety levels after HIFU.
- To determine the general health-related quality of life after HIFU.
- To determine the histological outcomes in the treated and untreated areas at 12 months
and 36 months after HIFU.
- To determine the proportion of men achieving trifecta status (i.e., no severe ED,
pad-free leak-free continence, cancer control with absence of CS-PC) at 36 months after
HIFU.
- To determine the rate of secondary prostate cancer intervention (prostatectomy,
radiotherapy, androgen ablation, whole-gland HIFU, or cryosurgery) after HIFU.
- To determine the risk factors for failure defined as presence of any cancer and
clinically significant cancer at study end.
- To analyze the outcome parameters in terms of biochemical (PSA) kinetics including
determining the optimal biochemical definition of failure.
- To describe composite outcomes of failure after HIFU.
- To determine the costs of treatment and model potential cost effectiveness using
comparative cancer control and functional outcomes at 36 months compared to other
cohort trials involving the management of localized prostate cancer.
- To determine the clinical validity (sensitivity, specificity, negative and positive
predictive values, inter-observer variability [MRI only]) of the following:
- Multi-parametric MRI to predict presence of clinically significant prostate cancer
on template transperineal prostate-mapping biopsies prior to focal therapy.
- MRI changes to predict presence of residual/recurrent clinically significant
prostate cancer on biopsy.
- HistoScanning™ to predict presence of clinically significant prostate cancer on
template transperineal prostate-mapping biopsies prior to focal therapy.
- HistoScanning™ to predict presence of residual/recurrent clinically significant
prostate cancer on biopsy.
OUTLINE: This is a multicenter study.
Patients undergo hemi-ablation with high-intensity focused ultrasound (HIFU); their
treatment covers the side of the gland in which the clinically significant lesion(s) have
been identified by a combination of MRI and biopsy.
Patients undergo multi-parametric MRI and HistoScanning™ at baseline and 12 and 36 months,
transrectal ultrasound biopsies at baseline and 12 months, and template transperineal biopsy
at baseline and 36 months. Patients complete questionnaires for health-related quality of
life, urinary, erectile, and bowel toxicity, and anxiety levels at baseline and periodically
after completion of treatment. Financial data are collected periodically to determine the
cost-effectiveness of this treatment compared to other therapy.
After completion of study treatment, patients are followed up at 6 weeks, 3 months, and then
every 6 months for up to 38 months.
Interventional
Primary Purpose: Treatment
Proportion of men who are free of any prostate cancer (PC) in the treated area AND are free of clinically significant PC in the untreated area 36 months after focal therapy comprising HIFU
No
Mark Emberton, MD, FRCS, MBBS
Study Chair
University College London Hospitals
Unspecified
CDR0000684020
NCT01194648
November 2010
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