Trial document




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  DRKS00010911

Trial Description

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Title

Local HDR brachytherapy
in case of localized prostate cancer

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Trial Acronym

Prostate AL

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URL of the Trial

[---]*

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Brief Summary in Lay Language

After the diagnosis of prostate cancer there are various treatment options, as surgical removal of the prostate and radiotherapy. Furthermore, there is an alternative treatment with focal ultrasound (HIFU) or to check- at certain conditions- the tumor closely and possibly initiate a curative treatment at a later time (Active Surveillance).
The aim of this study is to treat only the parts of the prostate, carrying the Tumor in order to Keep the rate of complications minimal.
The treatment technology planned is a special form of Radiation therapy named HDR brachytherapy.

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Brief Summary in Scientific Language

A targeted brachytherapy of a small circumscribed tumor within the prostate has not been carried out so far. By contrast, the focal HDR brachytherapy to other organs within multimodal concepts in Oligometastasierung or in the symptom-oriented palliation is already an established procedure.
The diagnosis of prostate cancer by MR imaging is increasing. Countless studies and meta-analyzes confirm now that the clinically relevant tumor can be detected with high sensitivity in the MR. At the same time, the methods for targeted puncture of suspicious lesions develop. In addition to the cognitive TRUS biopsy puncture and the fusion of MR and ultrasound data, the suspicious area can be punctured directly in the MR tube.
With this study, the feasibility study for the establishment of a simple and safe intervention and treatment protocol should be proved.

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Organizational Data

  •   DRKS00010911
  •   2016/08/29
  •   [---]*
  •   yes
  •   Approved
  •   109/16, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   interne Studiennummer  (RAD311)
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   If prostate carcinoma is shown, we recommend a minimally invasive intervention in the radiology department.
    Among nuclear spin magnetic resonance imaging conditions targeted brachytherapy of a small localized tumor is performed within the prostate. The selective irradiation of the tumor by catheter leads to necrotic degradation of tissue concerned. Results should be shown in an inactivation of tumor.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   I-II
  •   N/A
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Primary Outcome

Objective of the study is to establish a new method of treatment for prostate cancer, showing minimal side effects for the patient.
Parameters will be analyzed with a Safety (SAE management / side effect and quality of life questionnaires) which will be collected during study.

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Secondary Outcome

Evidence based of improvment in quality of life compared with standard therapy methods by patient satisfaction.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/09/01
  •   25
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Patients between 18 and 80 years, with a localized tumor of the prostate under low-risk or intermediate risk early to D'Amico, the standard procedures, such as percutaneous radiotherapy, radical prostatectomy or active surveillance refuse.
In preoperatively performed multiparametric MRI (mpMRT) at least one suspicious lesion with a PI-RADS score must be described by 4/5.

• Age 18 aged 80 or a life expectancy of at least 10 years
• MR biopsy or prostate fusionsbioptisch secured
• In accordance distinctly visible index lesions with PI-RADS score 4/5
• consent of focal treatment by using brachytherapy
• refusal of also introduced standard treatments

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Exclusion Criteria

several suspect lesion in mpMRT with a PI-RADS score of 4/5. Furthermore, symptoms that preoperatively additional treatments of the prostate makes necessary (z. B. TURP) equipment and other obstacles which do not allow to carry out the therapy.

• Missing capacity to consent
• evidence of lymph node or metastasis in the CT or MRI
• no suspect MR lesion (PIRADS 4/5)
• several suspect MR lesions (PIRADS 4/5)
• ongoing antihormonal therapy

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Addresses

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Mr.  Dr.  Peter  Hass 
    • Germany
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    • Klinik für Radiologie und NuklearmedizinUniversität Magdeburg
    • Mr.  Prof.  Jens  Ricke 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Klinik für Radiologie und Nuklearmedizin
    • Ms.  Christel  Besseler 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Radiologie und NuklearmedizinUniversität Magdeburg
    • Mr.  Prof.  Jens  Ricke 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting planned
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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.