Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009021

Trial Description

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Title

Focal therapy of prostate cancer using mpMRI/TRUS-guided high intensity focused ultrasound (HIFU) technology: a prospective register study (FOXPRO_REGISTER)

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Trial Acronym

FOXPRO_REGISTER

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URL of the Trial

http://none

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Brief Summary in Lay Language

Prospective register study to evaluate if focal therapy of prostate cancer using mpMRI/TRUS-guided HIFU represents a therapy alternative for localized prostate cancer in patients who refuse guideline conform prostate cancer treatment. We hypothesis that a local cancer control can be achieved.

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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

  •   DRKS00009021
  •   2015/10/19
  •   [---]*
  •   yes
  •   Approved
  •   2015-401M-MA-§ 23b MPG, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   U1111-1172-9491 
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   - Focal ablation of prostate cancer lesion or lesions within the prostate using multiparametricMRI/ transrectal-ultrasound(TRUS)-guided HIFU (device: FocalOne®, EDAP TMS GmbH, France) after diagnosis with a 12-core prostate biopsy or targeted biopsy of the prostate using mpMRI imaging
    - 12 months post-therapy control biopsy of prostate using multiparametricMRI/transrectal-ultrasound(TRUS)-fused prostatic 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 with negative mpMRI/TRUS fused biopsy at 12 mo after treatment*
*in case of contraindications against a MRI: ultrasound-guided only

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Secondary Outcome

Secondary treatment free time
Biochemical treatment failure
Metastatic-free survival
Cancer-specific mortality
Overall mortality
Functional outcome
Clinical validity of mpMRI to analyse the presence of residual or recurrent cancer compared with histopathologic findings using control biopsy*
*if no contraindications against a MRI
Assessment of safety:
60-day postoperative complications using Clavien-Dingo grading system

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/09/09
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- refusion of guideline conform prostate cancer therapy
- serum PSA: PSA ≤ 30 ng/ml
- mpMRT/TRUS bioptic proven prostate cancer:
Clinical stage: localized
- No inclusion into trial FOXPRO or FOXPRO_RAD possible

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Exclusion Criteria

acute urinary tract infection; lymph node or bone metastasis

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Addresses

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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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    •   0621-3832215
    •   [---]*
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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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    • 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
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    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 WeinheimHerr Senator e.h. Dr. h.c. Hans-Werner Hector
    • Mr. 
    • 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.