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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01194648
First received: September 2, 2010
Last updated: August 23, 2013
Last verified: November 2010
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • Proportion of men who are free of clinically significant PC in the treated and untreated area 36 months after HIFU [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ... [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Time to return of EF (absence of severe ED on IIEF-15 questionnaire) [ Designated as safety issue: No ]
  • Need for phosphodiesterase-5 inhibitors to maintain EF sufficient for penetration at 36 months [ Designated as safety issue: No ]
  • The presence of ejaculatory function at 12 and 36 months as measured by the orgasmic function domain of the IIEF-15 questionnaire [ Designated as safety issue: No ]
  • The presence of orgasmic function at 12 and 36 months as measured by the orgasmic function domain of the IIEF-15 questionnaire [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]
  • Presence of pain during intercourse requiring premature cessation of intercourse (i.e., prior to climax), at 36 months [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Presence of UI as determined by the UCLA-EPIC urinary continence questionnaire at 12 months and 36 months [ Designated as safety issue: No ]
  • Time to return of urinary continence (as determined by UCLA-EPIC Urinary domain questionnaire) [ Designated as safety issue: No ]
  • Grading of lower urinary tract symptoms as determined by IPSS scores at 12 months and 36 months [ Designated as safety issue: No ]
  • Presence of bowel toxicity as determined by the UCLA-EPIC Bowel questionnaire at 12 months and 36 months [ Designated as safety issue: No ]
  • Anxiety levels as measured by the Memorial Anxiety Scale for Prostate Cancer [ Designated as safety issue: No ]
  • General health-related quality of life as measured using EQ-5D and the RAND 36 item Health Survey125 [ Designated as safety issue: No ]
  • Absence of any PC on transrectal ultrasound (TRUS) biopsy in the treated area at 12 months [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Absence of CS-PC in the untreated area at 36 months by TTPM histology in patients who were free of CS-PC at baseline [ Designated as safety issue: No ]
  • Biochemical (PSA) kinetics and the optimal biochemical definition of failure [ Designated as safety issue: No ]
  • Composite end-point on cancer control as defined by time to failure defined on histological OR biochemical OR clinical parameters [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Evaluation of risk factors predictive of failure as defined by presence of any cancer or presence of CS-PC at study end [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • The clinical validity of HistoScanning™ to predict presence of residual/recurrent CS-PC on biopsy [ Designated as safety issue: No ]

Estimated Enrollment: 272
Study Start Date: November 2010
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194648

Locations
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
Investigators
Study Chair: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
Investigator: Hashim Uddinn Ahmed, MD University College London Hospitals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01194648     History of Changes
Other Study ID Numbers: CDR0000684020, UCL-INDEX, EU-21068
Study First Received: September 2, 2010
Last Updated: August 23, 2013
Health Authority: Unspecified

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014