Trial document




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  DRKS00007105

Trial Description

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Title

Focal therapy of localized prostate cancer using mpMRI/TRUS-guided high intensity focused ultrasound (HIFU) technology

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Trial Acronym

FOXPRO

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URL of the Trial

http://NONE

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Brief Summary in Lay Language

only german patients can take part in the study, for further info please contact the contact for public queries

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Brief Summary in Scientific Language

Focal therapies for localized prostate cancer are described in recent guidelines to be the therapeutic approach with the most important future potential in treatment. Focal therapy through HIFU focuses conglomeration of ultrasound waves on a specific point in the prostate and leads through overheating to protein denaturation and necrosis. The latest HIFU device for the first time utilizes the fusion of mpMRI and trans-rectal ultrasound(TRUS) imaging. Due to a high negative predictive value for mpMRI, it is used in combination with a mpMRI/TRUS-guided biopsy to decide which areas should not be treated.
The optimized mpMRI/TRUS-HIFU approach has potentially less morbidities than described whole gland treatment options. This mpMRT/TRUS HIFU technology holds great promise to progressively revolutionize the efficacy and safety of PCA treatment in selected patients.

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Organizational Data

  •   DRKS00007105
  •   2014/11/04
  •   [---]*
  •   yes
  •   Approved
  •   2014-423M-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   U1111-1163-2336 
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   - Treatment of prostate cancer lesion using multiparametricMRI/ transrectal-ultrasound(TRUS)-guided HIFU (device: FocalOne®, EDAP TMS GmbH, France)
    - 12 months post-therapy control biopsy of prostate using multiparametricMRI/transrectal-ultrasound(TRUS)-fused biopsy
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Focal ablation of prostate cancer lesion with negative mpMRI/TRUS fused biopsy at 12 mo after treatment

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Secondary Outcome

- 5-year secondary treatment free time
- Biochemical treatment failure
- Metastatic-free survival
- Cancer-specific mortality
- Overall mortality
- Functional outcome (incontinence voiding, erectile dysfunction, quality of life, anxiety)
- Clinical validity of mpMRI to analyse the presence of residual or recurrent cancer compared with histopathologic findings using mpMRT/TRUS-guided prostate biopsy
- 5-year costs of treatment
- 60-day postoperative complications using Clavien-Dingo grading system

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/09/02
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Serum PSA: PSA < 10 ng/ml
mpMRT/TRUS bioptic proven prostate cancer:
- Clinical stage: T1c, unifocal
- Gleason score ≤ 3 + 4
Life expectancy > 10 yr

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Exclusion Criteria

Previous treatment:
Previous treatment of the primary cancer within the prostate
Previous hormone treatment for prostate cancer within 6 months before trial
Previous radiation to pelvis
Active urinary tract infection
One or more of the following findings in multiparametric MRI:
PI-RADS score < 3 of the treatment lesion
PI-RADS score > 3 of opposite site
Extracapsular extension or seminal vesicle invasion

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Addresses

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    • Klinik für Urologie, Universitätsmedizin Mannheim
    • Mr.  Prof. Dr. med.  Maurice Stephan  Michel 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsmedizin Mannheim, Klinik für Urologie
    • Mr.  Dr. med.  Jost  von Hardenberg 
    • Theodor-Kutzner-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Klinik für Urologie, Universitätsmedizin Mannheim
    • Mr.  PD Dr. med.  Manuel  Ritter 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Klinik für Urologie, Universitätsmedizin Mannheim
    • Mr.  PD Dr. med.  Manuel  Ritter 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    end of 1:1-Block address contact public-contact
  • start of 1:1-Block address public-contact
    • Universitätsmedizin Mannheim, Klinik für Urologie
    • Mr.  Dr. med.  Jost  von Hardenberg 
    • Theodor-Kutzner-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • H.W. & J. Hector-Stiftung zu Weinheim
    • Mr.  Senator e.h. Dr. h.c.  Hans-Werner  Hector 
    • Elisabethstraße 9
    • 68165  Mannheim
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.