A Multi-Center Prospective Single Arm Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound (Sonablate 500) for Localized Prostate Cancer
N/A
N/A
Male
Male Erectile Disorder, Prostate Cancer, Therapy-related Toxicity, Urinary Incontinence
Trial Information
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer on transrectal or transperineal template
prostate biopsies
- Transrectal ultrasound (TRUS) biopsy: up to burden bilateral disease with
maximum 3 mm one biopsy on non-dominant side is allowed
- Template biopsy with the any of the following:
- Unilateral disease with any burden
- Bilateral disease with 1 of the following:
- Presence of clinically significant cancer on only one side (as
determined by histological rules described above) and Gleason ≤ 7
- Clinically insignificant disease with a burden of > 50% of biopsy
cores taken on that side
- Bilateral clinically insignificant disease and < 50% of biopsy cores
positive on any one side but with dominant disease burden on one side
- Low- to intermediate-risk disease, meeting all of the following criteria:
- PSA < 15 ng/mL
- Gleason score ≤ 4+3
- T1-T2c, N0, M0 disease (radiological T3a permitted)
- Untreated disease
- No presence of prostatic calcification and cysts (on TRUS) whose location will
interfere with effective delivery of high-intensity focal ultrasound (HIFU) therapy
- No evidence of metastatic disease or nodal disease outside the prostate on bone scan
or cross-sectional imaging
PATIENT CHARACTERISTICS:
- Must be fit for major surgery as assessed by an anesthesiologist
- Life expectancy ≥ 10 years
- Has an understanding of the English language sufficient to understand written and
verbal information about the trial and consent process
- Must be able to tolerate a transrectal ultrasound (TRUS)
- Must be able to have pelvic MRI scanning (e.g., severe claustrophobia, permanent
cardiac pacemaker, or metallic implant likely to contribute significant artifact to
images)
- No latex allergies
- No presence of metal implants/stents in the urethra
- No renal impairment with a GFR < 35 mL/min (unable to tolerate gadolinium dynamic
contrast-enhanced MRI)
PRIOR CONCURRENT THERAPY:
- No prior radiation therapy
- No androgen suppression/hormone treatment within the past 12 months for prostate
cancer
- No prior significant rectal surgery preventing insertion of trans-rectal HIFU probe
(decided on the type of surgery in individual cases)
- No prior HIFU, cryosurgery, thermal or microwave therapy to the prostate
- More than 6 months since prior transurethral resection of the prostate (TURP) to
manage lower urinary tract symptoms
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Mark Emberton, MD, FRCS, MBBS
Investigator Role:
Study Chair
Investigator Affiliation:
University College London Hospitals
Authority:
Unspecified
Study ID:
CDR0000684020
NCT ID:
NCT01194648
Start Date:
November 2010
Completion Date:
Related Keywords:
- Male Erectile Disorder
- Prostate Cancer
- Therapy-related Toxicity
- Urinary Incontinence
- urinary incontinence
- male erectile disorder
- therapy-related toxicity
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- Prostatic Neoplasms
- Urinary Incontinence
- Erectile Dysfunction
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