Trial document





This trial has been registered retrospectively.
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  DRKS00007775

Trial Description

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Title

Feasibility of focal treatment of localized prostate cancer with MRI / TRUS image fusion using the Focal One

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Trial Acronym

PRO FOCUS

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Comparative and non-comparative studies have equivalence of observational strategy with radical prostatectomy described with localized low-risk carcinoma. The focal therapy of prostate for several years touted as an experimental concept and published by various authors. The English organization Nice 2012 has a guideline-like recommendation written that recommends the focal treatment of prostate cancer with the aim of healing and preservation of quality of life.

Patients with localized prostate cancer at low or intermediate risk early are treated potentially by the standard therapies radical prostatectomy and external radiation therapy with potentially avoidable side effects. The present study evaluates the feasibility of focal, ie targeted therapy, the tumor bearing portion of the prostate with the aim to achieve a more favorable side effect spectrum with the same oncologic control

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Organizational Data

  •   DRKS00007775
  •   2016/04/11
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  •   yes
  •   Approved
  •   01/15, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1181-6943 
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
  •   prostate cancer
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Interventions/Observational Groups

  •   Patients with unilateral prostate cancer who are eligible for an Active Surveillance

    after treatment and discharge from the hospital follow up examinations in the months 1, 3, 6, 12, 15, 18, 21, 24

    These include:

    - Physical examination (1, 3, 6, 12, 18, 24)
    - Transrectal ultrasound (3, 6, 12, 18, 24)
    - PSA test (3, 6, 15, 18, 21, 24)
    - MpMRT prostate - MR-guided control biopsy or MRI / TRUS fusion biopsy or cognitive Fusi-on the areas treated in combination with a random biopsy of all other standard targets (6, 24)
    - Uroflow (3, 6, 18, 24)
    - Adverse Events (1, 3, 6, 12, 18, 24)
    - Detection of additional treatment (all FU visits)
    - Assessing Quality of Life with the o g quality of life scores (3, 6, 18, 24)..
    - Documentation of adverse side effects and any, the treatment that adversely affect, drug or other therapeutic and / or anticancer therapy (all visits)
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Characteristics

  •   Interventional
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  •   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

Bioptic tumor tissue of the treated areas within the MRI guided biopsy or MRI / TURS fusion biopsy after 6 month

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Secondary Outcome

all at inclusion and FU visits Months 3, 6, 18, 24:
- Incontinence: changes in the ICS-male SF score - micturition: changes in IPSS score
- Potency: changes in IIEF-5 score
- Quality of life: EORTC QLQ C30, Version 3.0
- Anxiety and psychological stress: changes in HADS-Scale

all at treatment and day of discharge and FU-months 1,3, 6, 12, 18, 24:
- Safety: detection of adverse reactions to Clavien-Dindo

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • other 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/03/01
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Life expectancy> 10 years, PSA <= 15 ng / ml, clinically localized prostate cancer, the number of infested punching <= 30% of the extracted stamping cylinder, Gleason score <= 3 + 4 = 7, normal anal and rectal anatomy, maximum 2 in mpMRT visible lesions with PI-RADS score 4/5, rejection of also featured standard therapies, at least a visible lesion in mpMRT with a PI-RADS score 4/5, Accordance suspect mpMRT-areas with areas of positive punching

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Exclusion Criteria

not limited clinical tumor stage, evidence of lymph node or distant metastases in the imaging, more than 2 visible MRI lesions with PI-RADS 4/5, no suspicious MRI lesion (PI RAS 4/5) with positive punch in the same sector, existing Urethralstenosen, unresolved coagulopathy, untreated urogenital infections, latex allergies, contraindications to MRI (pacemaker, metal prostheses o. ä.), participating in a treatment study for prostate within the last 30 days, missing capacity to consent, ongoing antihormonal therapy, TURP in the last 6 months

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik für Urologie und Kinderurologie
    • Mr.  Prof. Dr. med.  Martin  Schostak 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinikum Magdeburg A. ö. R.Klinik für Urologie und Kinderurologie
    • Mr.  Prof. Dr. med.  Martin  Schostak 
    • Leipziger Strasse 44
    • 39104  Magdeburg
    • Germany
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    • Universitätsklinikum Magdeburg A. ö. R.
    • Mr.  Prof. Dr. med.  Martin  Schostak 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Gesellschaft für UrologieArbeitskreis Fokale und Mikrotherapie der Akademie
    • Mr.  Prof. Dr. med.  Martin  Schostak 
    • Leipziger Str. 44
    • 39120   Magdeburg
    • Germany
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    • Universitätsklinik für Urologie und Kinderurologie
    • Mr.  Prof. Dr. med.  Martin  Schostak 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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