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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01555086

Acronym

SEAL

Enrollment

500

Registered

2012-03-15

Start date

2011-08-31

Completion date

Unknown

Last updated

2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Lymphadenectomy, Prostate cancer

Brief summary

This study examines Limited versus extended pelvic lymphadenectomy.

Detailed 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.

Interventions

PROCEDURELimited pelvic Lymphadenectomy

approximately 10-14 lymph nodes are removed

PROCEDUREExtended pelvic Lymphadenectomy

approximately 20 lymph nodes are removed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
PSA-progress	5 years	3-monthly Follow-up with PSA-measurement in blood

Secondary

Measure	Time frame	Description
Comparison of overall survival	5 years	Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy
Comparison of morbidity	5 years	Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy

Countries

Germany

Contacts

Primary ContactHeidrun Rexer

heidrun.rexer@meckevidence.de

Backup ContactAxel Heidenreich, Prof. Dr.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026