Trial document




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  DRKS00005180

Trial Description

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Title

Prospective phase II study of focal therapy (Hemiablation) of the prostate by high intensity focused ultrasound (HIFU) in patients with suitability for Active Surveillance (HEMI)

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Trial Acronym

Hemi

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Study of focal therapy (Hemiablation) of the prostate by high intensity focused ultrasound (HIFU) in patients with suitability for Active Surveillance.
There are 50 patients will be enrolled, which are followed up for 1 year after treatment.
The aim of this study is to find out how many patients have initiated a definitive therapy (radical prostatectomy, radiation, complete HIFU, cryotherapy, hormone therapy) after one year.

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Brief Summary in Scientific Language

Prospective phase II study of focal therapy (Hemiablation) of the prostate by high intensity focused ultrasound (HIFU) in patients with suitability for Active Surveillance

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Organizational Data

  •   DRKS00005180
  •   2014/04/10
  •   [---]*
  •   yes
  •   Approved
  •   11-101-0156, Ethikkommission an der Universität Regensburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

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

  •   Hemiablation the prostate by HIFU
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Characteristics

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

No initiation of definitive therapy (radical prostatectomy, radiation, complete HIFU, cryotherapy, hormone therapy) after one year

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Secondary Outcome

• Criteria for the study participants to qualified for an Active Surveillancen within the observation period. After following criteria, an AS must be vacated:
- Gleason score> 6
- PSA doubling time <3 years
- Decision of the patient for definitive therapy (radical prostatectomy, radiation, complete HIFU, cryotherapy, hormone therapy)
- Stages of progression> T2a

• Bioptic tumor freedom after 1 year
- The treated prostate half
- The untreated prostate half

• Overall survival (defined as time to death of any cause) [Time Frame: 1 year]

• Prostate cancer-specific survival (defined as time to death due to prostate cancer) [Time Frame: 1 year]

• Morbidity [Time Frame: 1 year]:

- Continence :
- Changes in the ICS male SF-Score

- Micturition :
- Changes in IPSS-Score

- Potency:
- Changes in the IIEF 5-Score

- Quality of life :
- Changes in the EORTC QLQ 30 (version 3.0)

- Anxiety and psychological distress :
- Change in HADS ( Hospital Anxiety and Depression Scale )

• Security [Time Frame: 1 year]:
- The incidence of all side effects during and after treatment, which associated with the treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2014/09/30
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

• Patients aged > 18 years
• Bioptic secured prostate cancer
• Clinical stage T1c - T2a
• PSA <= 10 ng/ml
• Gleason Score <= 7a (3+4)
• One-sided tumor attack
• Proportion of infected tumor stamp in the total number of stamp of collected stamp <30% and the largest continuous tumor stove <5 mm
• Height of the peripheral zone of the prostate to be treated in TRUS:
o ≤ 30 mm when treated with Ablatherm Integrated Imaging
o ≤ 40 mm when treatment with Focal One
• No evidence of significant carcinoma of the opposite side in multiparametric MRI (defined as PI-RADS score 4 and 5)
• Thickness of the rectal wall <6 mm in TRUS
• Willingness of the participant to attend all follow-up visits (for 12 months)

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Exclusion Criteria

- Previous therapie of prostate cancer as radiation, hormonotherapy (including bilateral orchiectomy and plastic orchiectomy)
- Previous surgery of prostate and urethra within the last 6 month (TUR-prostate, urethrotomy, bladder neck incision)
- Taking of 5-alpha-reductase inhibitors (finasteride or dutasteride) within the last 6 month
- Stenosis of the rectum
- Acute urinary tract infection
- Acute bleeding coagulopathy
- Allergy of latex
- Participation of another clinical or pharmacological trial during the last 30 days

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Addresses

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    • Universitätsklinikum Regensburg
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
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    • Klinik und Poliklinik für UrologieUniversitätsklinikum Leipzig AöR
    • Mr.  PD Dr.  Roman  Ganzer 
    • Liebigstraße 20
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik für Urologie, Universitätsklinikum Leipzig AöR
    • Mr.  PD Dr.  Roman  Ganzer 
    • Liebigstraße 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Arbeitskreis für Fokale- und Mikrotherapie der Akademie der DGU e.V
    • Mr.  Prof. Dr.  Kai Uwe  Köhrmann 
    • Bassermannstr. 1
    • 68165  Mannheim
    • Germany
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    •   [---]*
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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.