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Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02265159
Recruitment Status : Unknown
Verified October 2016 by Daniel Eberli, University of Zurich.
Recruitment status was:  Recruiting
First Posted : October 15, 2014
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Daniel Eberli, University of Zurich

Tracking Information
First Submitted Date  ICMJE September 29, 2014
First Posted Date  ICMJE October 15, 2014
Last Update Posted Date October 27, 2016
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
  • Oncological safety [ Time Frame: 36 months ]
    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
  • Oncological safety [ Time Frame: 36 months ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
  • Biochemical failure [ Time Frame: 36 months ]
    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
  • Sensitivity and specificity of MRI imaging [ Time Frame: 36 months ]
    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
  • Health care costs [ Time Frame: 36 months ]
    To determine the costs of treatment and longitudinal morbidity associated with complications at 36 months compared to other treatments of localized prostate cancer.
  • Erectile function [ Time Frame: 36 months ]
    Rate of erectile dysfunction and time to return of erectile function (measured by the IIEF-15)
  • Orgasmic function [ Time Frame: 36 months ]
    Rate of loss of ejaculation and orgasm (measured by the IIEF-15)
  • Sexual function [ Time Frame: 36 months ]
    Rate of pain during intercourse
  • Erectile function [ Time Frame: 36 months ]
    Number of men using phosphodiesterase-5 inhibitors to maintain erectile function (measured by the IIEF-15)
  • Continence [ Time Frame: 36 months ]
    Rate of urinary incontinence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)
  • Continence [ Time Frame: 36 months ]
    Time to return of continence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)
  • Lower urinary tract symptoms [ Time Frame: 36 months ]
    Rate of lower urinary tract symptoms (as determined by IPSS scores)
  • Bowel function [ Time Frame: 36 months ]
    Rate of bowel toxicity (determined by the UCLA-EPIC Bowel questionnaire )
  • Anxiety [ Time Frame: 36 months ]
    Anxiety levels (measured by the Hospital Anxiety and Depression Scale and Memorial Anxiety Scale for Prostate Cancer
  • Quality of life [ Time Frame: 36 months ]
    General health related quality of life (measured using FACT-P Version 4 )
  • General histological outcome [ Time Frame: 36 months ]
    To determine the histological outcomes at 6, 12 and 36 months
  • Secondary intervention [ Time Frame: 36 months ]
    Rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer
Official Title  ICMJE Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Procedure: Focal Therapy Using High Intensity Focused Ultrasound
Other Name: Focal HIFU
Study Arms  ICMJE Focal Therapy Using High Intensity Focused Ultrasound
Intervention: Procedure: Focal Therapy Using High Intensity Focused Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 9, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies
  • Template biopsy:

    • unilateral disease (Gleason ≤4+3)
    • bilateral disease: presence of clinically significant cancer in both sides (Gleason ≤4+3) OR clinically insignificant disease with a burden of >50% of biopsy cores taken on that side, OR bilateral clinically insignificant disease and <50% of biopsy cores positive on any one side but with dominant disease burden on one side
  • Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted)
  • Serum PSA ≤15
  • Life expectancy of ≥10 years
  • Signed informed consent by patient
  • An understanding of the German language sufficient to understand written and verbal information about the trial and consent process

Exclusion Criteria:

  • Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
  • Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
  • Men with an inability to tolerate a transrectal ultrasound
  • Men with latex allergies as the HIFU probe is covered with a latex condom sheath prior to insertion into the back passage
  • Men who have undergone prior significant rectal surgery preventing insertion of trans-rectal HIFU probe (decided on the type of surgery in individual cases)
  • Men who have had previous HIFU, cryosurgery, thermal or microwave therapy to the prostate.
  • Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.
  • Men not fit for major surgery as assessed by a Consultant Anaesthetist
  • Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
  • Presence of metal implants/stents in the urethra
  • Presence of prostatic calcification and cysts (on transrectal ultrasound) whose location will interfere with effective delivery of HIFU therapy
  • Men with renal impairment with a glomerular filtration rate of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02265159
Other Study ID Numbers  ICMJE KEK-ZH-Nr. 2013-0415
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Eberli, University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE University College, London
Investigators  ICMJE
Principal Investigator: Daniel Eberli, PD Dr. PhD Klinik für Urologie, Universitätsspital Zürich
PRS Account University of Zurich
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP