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Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy

18 Years
75 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy

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 choice. This study shell
show if one method is more effective than the other.

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

3-monthly Follow-up with PSA-measurement in blood

Outcome Time Frame:

5 years

Safety Issue:



Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AP 55/09



Start Date:

August 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Lymphadenectomy
  • Prostate cancer
  • Prostatic Neoplasms