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

Prostate Cancer Clinical Trial

— SEAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01555086
• Other study ID #: AP 55/09
• Secondary ID: DRKS00003256
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2012
• Last updated: January 23, 2017
• Start date: August 2011

Study information

• Verified date: January 2017
• Source: Association of Urogenital Oncology (AUO)
• Contact: Heidrun Rexer
• Email: heidrun.rexer[@]meckevidence.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines Limited versus extended pelvic lymphadenectomy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Limited pelvic Lymphadenectomy
approximately 10-14 lymph nodes are removed
• Extended pelvic Lymphadenectomy
approximately 20 lymph nodes are removed

Locations

Country	Name	City	State
Germany	RWTH Aachen	Aachen	Pauwelsstraße 30
Germany	Städtisches Klinikum Fulda	Fulda	Pacelliallee 3-5
Germany	St. Antonius-Krankenhaus	Gronau	Möllenweg 22
Germany	Martiniklinik am UKE	Hamburg	Martinistraße 52
Germany	Krankenhaus Maria Hilf	Krefeld	Dießemer Bruch 80

Sponsors (1)

Lead Sponsor	Collaborator
Association of Urogenital Oncology (AUO)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA-progress	3-monthly Follow-up with PSA-measurement in blood	5 years
Secondary	Comparison of overall survival	Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy	5 years
Secondary	Comparison of morbidity	Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy	5 years