Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00018103

Trial Description

start of 1:1-Block title

Title

Observational study of therapy with High Intensive Focused Ultrasound (HIFU) at Prostate Cancer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

HIFU registry

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http:///

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Patients with prostate cancer are scheduled to receive high-intensity, focused ultrasound (HIFU) therapy. It is intended to ensure the most reliable statement possible regarding treatment success and therapy safety for future patients. For this it is necessary to record therapy data and results of follow-up of almost every HIFU therapy.
For this purpose, an Internet-based database was installed. This database documents the clinical and epidemiological data of the patients, the therapeutic parameters, patient stickers, the postoperative course in quality of life and the healing result. These data are pseudonymised after strict assignment to the personal data in the attending clinic and under strictest privacy concerns. They are identifiable only to the attending physician.
The database is managed centrally by IOMTech GmbH (Berlin). The database was subject to editions of privacy. For this reason, patients receive multiple questionnaires, twice in the first year, then once a year. In it, they are asked about the current PSA and any other therapies, as well as the quality of life. It is especially about the continence and the potency, as well as any problems with urination. The content of the questionnaire is entered electronically in the database, the paper version remains under the usual conditions of medical confidentiality in the patient record.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Prostate cancer, the most common male tumor disease in the Federal Republic of Germany, can be curatively treated via various therapeutic measures. High Intensity Focused Ultrasound (HIFU) has been used clinically for many years. The oncotherapeutic effectiveness and the side effect spectrum are in clinical studies well documented. However, data from larger series from the health services research is missing. In September 2009, new interdisciplinary quality S3 guidelines were published for the early detection, diagnosis and treatment of the various stages of prostate cancer. It states that currently no study data available, which allow an evaluation of HIFU. A routine use of the therapy for the indication is therefore not justified. The background text of this statement clarifies that HIFU should, if possible, be carried out as part of clinical observations. Only one especially in the medium term, the high density of therapy data can justify a sufficient basis for a therapy recommendation with a better level of evidence.
An Internet-based database for recording the required parameters already exists since 2009: the so-called "@-registry". In this database, the clinical and epidemiological data of the patients, the therapy parameters and the postoperative course in quality of life and oncotherapeutic outcome documented. With the application observation presented here, we strive for a comprehensive system for almost complete recording of all HIFU therapies in the Federal Republic of Germany.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00018103
  •   2019/09/26
  •   [---]*
  •   yes
  •   Approved
  •   13/13, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1239-3333 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   - Almost all in Germany with HIFU-treated patients should be included about 1000 patients
    - All cases to be documented for the observation of the application are carried out with the devices of EDAP TMS (Vaulx-en-Velin, France).
    1. Baseline:
    If HIFU therapy is planned for a patient with prostate cancer, clarification of the planned documentation of the patient's clinical data within the framework of the "@ registry". In the course of the following parameters are recorded and documented:
    • Staging by assessing the local stage (T1 / T2 / T3), lymph node stage (N0 / NX / N1) and stage of metastasis (M0 / MX / M1).
    • Medical comorbidity (including previous operations).
    • Initial PSA value and, if known, additional PSA values ​​in the course.
    • The histologic findings with date. It is differentiated whether the tissue was obtained by biopsy, by transurethral resection or otherwise.
    • Basic imaging: MRI / CT / PET scan / whole body scintigraphy / ultrasound / transrectal ultrasound.

    2. Therapy Parameters of HIFU Therapy:
    - Date of Therapy, Therapy Protocol, Intention of Therapy: Complete Gland, focal therapy (yes / no or nerve-sparing planned, if so: one-sided / bilateral), number of total administered Lesions, treated volume, duration of treatment, prostate volume (TRUS), prostate AP diameter, prostate length, prostate width, anesthesia form, pretreatment, in particular TUR-P / TUI-P / urethrotomy o. A. (if necessary, the number of grams of tissue obtained in the tran-surethral resection). Type of permanent catheter insertion (suprapubic / transurethral), date of catheter removal and total duration of catheterization.

    3. Follow up:
    There should be a follow-up at yearly intervals. For this purpose, dynamic progress sheets are created, which include a recurrence / progress by means of PSA history and documented control histology. Any imaging or clinical findings can be recorded. Furthermore, the follow-up includes standardized questionnaires regarding micturition problems, general quality of life, continence and potency, eventually Accompanying or sequelae, especially inpatient admissions, surgical therapy etc documented.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Overall survival of patients
There should be a follow-up at yearly intervals. For this purpose, dynamic progress sheets are created, which document a recurrence / progress by means of PSA course and possibly obtained control histology. Any imaging or clinical findings can be recorded.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Tumor-specific survival
- Analysis of the acute and late toxicity of the procedure (effectiveness and effectiveness of HIFU therapy)
The follow-up includes standardized questionnaires regarding micturition problems, general quality of life, continence and potency, and finally, concomitant or sequelae, in particular hospitalisation, surgical therapy or others are documented.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/05/13
  •   1000
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

1. Patients with prostate cancer in whom a local therapy an improvement of disease situation promises
2. Consent to voluntary participation in the observational study after complete education on nature and purpose of observation, confirmed by signature on enlightenment document

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

1. Acute, untreated urinary tract infection
2. Pre-existing urinary or rectal fistula
3. Anal stenosis, the introduction of the HIFU transducer does not allow

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik für Urologie und Kinderurologie
    • Mr.  Prof. Dr. med.  Martin  Schostak 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Klinikum Fürth Klinik für Urologie und Kinderurologie
    • Mr.  Prof. Dr. med.  Andreas  Blana 
    • Jakob-Henle-Strasse 1
    • 90766  Fürth
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universitätsklinik für Urologie und Kinderurologie
    • Mr.  Prof. Dr. med.  Martin  Schostak 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinik für Urologie und Kinderurologie
    • Mr.  Prof. Dr. med.  Martin  Schostak 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • 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
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinik für Urologie und Kinderurologie
    • Mr.  Prof. Dr. med.  Martin  Schostak 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications


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