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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Focal Therapy Using High Intensity Focused Ultrasound Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer
Study Start Date : May 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Focal Therapy Using High Intensity Focused Ultrasound Procedure: Focal Therapy Using High Intensity Focused Ultrasound
Other Name: Focal HIFU




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. Erectile function [ Time Frame: 36 months ]
    Rate of erectile dysfunction and time to return of erectile function (measured by the IIEF-15)

  5. Orgasmic function [ Time Frame: 36 months ]
    Rate of loss of ejaculation and orgasm (measured by the IIEF-15)

  6. Sexual function [ Time Frame: 36 months ]
    Rate of pain during intercourse

  7. Erectile function [ Time Frame: 36 months ]
    Number of men using phosphodiesterase-5 inhibitors to maintain erectile function (measured by the IIEF-15)

  8. Continence [ Time Frame: 36 months ]
    Rate of urinary incontinence (pad free, leak free and padfree alone) (determined by the UCLA-EPIC urinary continence questionnaire)

  9. 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)

  10. Lower urinary tract symptoms [ Time Frame: 36 months ]
    Rate of lower urinary tract symptoms (as determined by IPSS scores)

  11. Bowel function [ Time Frame: 36 months ]
    Rate of bowel toxicity (determined by the UCLA-EPIC Bowel questionnaire )

  12. Anxiety [ Time Frame: 36 months ]
    Anxiety levels (measured by the Hospital Anxiety and Depression Scale and Memorial Anxiety Scale for Prostate Cancer

  13. Quality of life [ Time Frame: 36 months ]
    General health related quality of life (measured using FACT-P Version 4 )

  14. General histological outcome [ Time Frame: 36 months ]
    To determine the histological outcomes at 6, 12 and 36 months

  15. Secondary intervention [ Time Frame: 36 months ]
    Rate of secondary prostate cancer intervention (prostatectomy, radiotherapy, androgen ablation)



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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, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).

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): NCT02265159


Contacts
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Contact: Daniel Eberli, PD Dr. PhD +41 44 255 95 49 Daniel.Eberli@usz.ch
Contact: Ashkan Mortezavi, Dr. +41 44 255 11 11 Ashkan.Mortezavi@usz.ch

Locations
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Switzerland
Klinik für Urologie, Universitätsspital Zürich Recruiting
Zürich, Switzerland, 8044
Contact: Daniel Eberli, PD Dr. PhD    +41 44 255 95 49    Daniel.Eberli@usz.ch   
Contact: Ashkan Mortezavi, Dr.    +41 44 255 11 11    Ashkan.Mortezavi@usz.ch   
Principal Investigator: Daniel Eberli, PD Dr. PhD         
Sub-Investigator: Tullio Sulser, Prof.         
Sub-Investigator: Ashkan Mortezavi, Dr.         
Sponsors and Collaborators
University of Zurich
University College, London
Investigators
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Principal Investigator: Daniel Eberli, PD Dr. PhD Klinik für Urologie, Universitätsspital Zürich
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Responsible Party: Daniel Eberli, PD Dr. med. PhD, University of Zurich
ClinicalTrials.gov Identifier: NCT02265159    
Other Study ID Numbers: KEK-ZH-Nr. 2013-0415
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases