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High-Intensity Focused Ultrasound in Treating Patients With Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01194648
Recruitment Status : Unknown
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : September 3, 2010
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by heating them without affecting normal tissue.

PURPOSE: This phase II trial is studying high-intensity focused ultrasound in treating patients with localized prostate cancer.

Condition or disease Intervention/treatment Phase
Male Erectile Disorder Prostate Cancer Therapy-related Toxicity Urinary Incontinence Other: questionnaire administration Procedure: assessment of therapy complications Procedure: high-intensity focused ultrasound ablation Procedure: multiparametric magnetic resonance imaging Procedure: quality-of-life assessment Procedure: transperineal prostate biopsy Procedure: transrectal prostate biopsy Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Primary Purpose: Treatment
Official Title: A Multi-Center Prospective Single Arm Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound (Sonablate 500) for Localized Prostate Cancer
Study Start Date : November 2010
Estimated Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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
  2. Proportion of men who are free of clinically significant PC in the treated and untreated area 36 months after HIFU

Secondary Outcome Measures :
  1. The presence of severe erectile dysfunction (ED) at 12 and 36 months, as measured by the International Index of Erectile Function (IIEF-15) questionnaire with or without the use of phosphodiesterase-5 inhibitors, in those with absence of severe ED at ...
  2. The presence of any new/progression of ED at 12 and 36 months, measured as an at least 6-point drop in IIEF-15 questionnaire score within the erectile function (EF) domain
  3. Time to return of EF (absence of severe ED on IIEF-15 questionnaire)
  4. Need for phosphodiesterase-5 inhibitors to maintain EF sufficient for penetration at 36 months
  5. The presence of ejaculatory function at 12 and 36 months as measured by the orgasmic function domain of the IIEF-15 questionnaire
  6. The presence of orgasmic function at 12 and 36 months as measured by the orgasmic function domain of the IIEF-15 questionnaire
  7. Presence of a significant decrease in penile length at 36 months as measured by pre-and post-treatment stretch-flaccid penile length (patients at UCLH/ UCL trial center only)
  8. Presence of pain during intercourse requiring premature cessation of intercourse (i.e., prior to climax), at 36 months
  9. Presence of urinary incontinence (UI; any pad usage plus any leakage of urine) as determined by the UCLA-EPIC urinary continence questionnaire, at 12 months and 36 months, in those men with no UI at baseline
  10. Presence of UI as determined by the UCLA-EPIC urinary continence questionnaire at 12 months and 36 months
  11. Time to return of urinary continence (as determined by UCLA-EPIC Urinary domain questionnaire)
  12. Grading of lower urinary tract symptoms as determined by IPSS scores at 12 months and 36 months
  13. Presence of bowel toxicity as determined by the UCLA-EPIC Bowel questionnaire at 12 months and 36 months
  14. Anxiety levels as measured by the Memorial Anxiety Scale for Prostate Cancer
  15. General health-related quality of life as measured using EQ-5D and the RAND 36 item Health Survey125
  16. Absence of any PC on transrectal ultrasound (TRUS) biopsy in the treated area at 12 months
  17. Histology of men with absence of clinically significant (CS) PC in the treated area at 36 months in patients who had CS-PC in the treated area
  18. Absence of any PC in the untreated area at 36 months by transperineal template prostate mapping (TTPM) histology in patients who had no PC at baseline TTPM in the untreated area
  19. Absence of CS-PC in the untreated area at 36 months by TTPM histology in patients who were free of CS-PC at baseline
  20. Biochemical (PSA) kinetics and the optimal biochemical definition of failure
  21. Composite end-point on cancer control as defined by time to failure defined on histological OR biochemical OR clinical parameters
  22. Achievement of trifecta status (i.e., no severe ED, pad-free leak-free continence, cancer control with absence of CS-PC) at 36 months in men with good baseline function
  23. Time to initiation of secondary PC intervention (prostatectomy, radiotherapy, androgen ablation, whole-gland HIFU, or cryosurgery) as a result of histological burden ≥ Gleason pattern 3 and/or max CCLI ≤ 3 mm or rising PSA or for any cause
  24. Evaluation of risk factors predictive of failure as defined by presence of any cancer or presence of CS-PC at study end
  25. Development of healthcare economic model to evaluate the cost-effectiveness by comparison of GU and cancer control outcomes against matched groups from existing studies evaluating standard care (active surveillance and radical therapies)
  26. The clinical validity (sensitivity, specificity, negative and positive predictive values, inter-observer variability) of MRI changes to predict presence of residual/recurrent CS-PC on biopsy
  27. The clinical validity of multi-parametric MRI or HistoScanning™ to predict presence of CS-PC on template transperineal prostate-mapping biopsies prior to focal therapy
  28. The clinical validity of HistoScanning™ to predict presence of residual/recurrent CS-PC on biopsy

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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)


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194648

United Kingdom
University College of London Hospitals Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Contact Person    44-203-447-9194    louise.dickinson@uclh.nhs.uk   
Sponsors and Collaborators
University College London Hospitals
Study Chair: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
OverallOfficial: Hashim Uddinn Ahmed, MD University College London Hospitals

ClinicalTrials.gov Identifier: NCT01194648     History of Changes
Other Study ID Numbers: CDR0000684020
First Posted: September 3, 2010    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: November 2010

Keywords provided by National Cancer Institute (NCI):
urinary incontinence
male erectile disorder
therapy-related toxicity
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Urinary Incontinence
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological