Trial document




drksid header

  DRKS00003256

Trial Description

start of 1:1-Block title

Title

Prospective Randomized Study to Compare a Limited versus Extended Pelvine Lymphadenectomy during Prostatectomy - SEAL - AP 55/09

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

Trial Acronym

SEAL

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

This study is meant to show if the extension of lymphadenectomy during prostatectomy has an influence of outcome of patients. Patients with indication to prostatectomy due to prostate cancer will be included.
Both extensions of lymphadenectomy are used in hospitals as a free choise. This study shell show if one method is more effective than the other.


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

Brief Summary in Scientific Language

Influence of different extension of Lymphadenectomy to outcome of patients (PSA-Progress)

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003256
  •   2012/01/20
  •   2011/08/05
  •   yes
  •   Approved
  •   2010220, Ethikkommission der Ärztekammer Nordrhein
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01555086  (clinicaltrials.gov)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

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

Interventions/Observational Groups

  •   Limited pelvine Lymphadenectomy
  •   Extended pelvine Lymphadenectomy
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

PSA-progresse within 5 years, 3-monthly Follow-up with PSA-measurement in blood

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

Secondary Outcome

- Comparison of overall survival and morbidity after limited versus extended lymphadenectomy within 5 years after prostatectomy
- Development of standard surgery procedures of the radical prostatectomy and lymphadenectomy as well as histopathological procedures for evaluation of tissues. For surgery therapy a precise definition of lymphnode fields that should be cleared within pelvine lymphadenectomy is very relevant. Also, the implementation of quality criteria like minimum account of lymphnodes to clear and definition of resection frames via additional tissue probes evaluation from resection frame. These standards shell be implemented into UICC-classification then.

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

Recruitment

  •   Actual
  •   2011/08/16
  •   500
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- stamp bioptic secured prostate cancer with intermediate or high risk profile (defined as Gleason-Score 7-10 or PSA > 10 ng/ml)

- locally-operable tumor according to DRU/TRUS

- negative bone scan

- negative CT abdomen / pelvis

- general condition according to Karnofsky >/= 80%

- written consent of the patient

- adequate hematological, renal and coagulation physiological functions

- Patient compliance and geographic proximity to allow adequate follow-up

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

Exclusion Criteria

Manifest secondary malignancy
Secured metastasis by histologically or by imaging
Myocardial infarction or stroke within the last 6 months
Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or hematopoietic (eg severe bone marrow aplasia) diseases
Severe active or chronic infections (eg pos. HIV-Ab test, HBs-Ag detection in serum and / or chronic hepatitis)
severe psychiatric disease
prior chemotherapy (allowed is a preoperative antiandrogen therapy ≤ 3 months)
previous pelvic radiotherapy
Patients in a closed institution according to an authority or court decision
People who are in a dependent relationship or working relationship with the sponsor or investigator
simultaneous participation in another clinical trial

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Univsitätsklinikum Essen
    • Ms.  Dr.  Katrin  Weidler 
    • Hufelandstr. 55
    • 45147  Essen
    • 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 scientific-contact
    • Uniklinik Köln, Klinik und Poliklinik für Urologie
    • Mr.  Prof. Dr.  Axel  Heidenreich 
    • Kerpener Str. 62
    • 50937  Köln
    • 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
    • Uniklinik Köln, Klinik und Poliklinik für Urologie
    • Mr.  Prof. Dr.  Axel  Heidenreich 
    • Kerpener Str. 62
    • 50937  Köln
    • 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
    • Arbeitsgemeinschaft Urologische Onkologie (AUO) in der Deutschen Krebsgesellschaft e. V.
    • Seestr. 11
    • 17252  Schwarz
    • 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
start of 1:n-Block dynamic attributes

Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
    start of 1:1-Block address
    • Uniklinik Köln, Klinik und Poliklinik für Urologie
    • Mr.  Prof. Dr.  Axel  Heidenreich 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address
    start of 1:1-Block address contact
    end of 1:1-Block address contact
  • Further contact 
    start of 1:1-Block address
    • [---]*
    end of 1:1-Block address
    start of 1:1-Block address contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact
  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
  • AUO studynr. 
end of 1:n-Block dynamic attributes
* This entry means the parameter is not applicable or has not been set.