Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy (SEAL)

Association of Urologic Oncology (AUO)

Status: Unknown

Conditions: Prostate Cancer

Treatments: Procedure: Limited pelvic Lymphadenectomy; Procedure: Extended pelvic Lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01555086

DRKS00003256 (Registry Identifier)

AP 55/09

Details and patient eligibility

About

This study examines Limited versus extended pelvic lymphadenectomy.

Full description

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.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Limited pelvic Lymphadenectomy

Experimental group

Treatment:

Procedure: Limited pelvic Lymphadenectomy

Extended pelvic Lymphadenectomy

Experimental group

Treatment:

Procedure: Extended pelvic Lymphadenectomy