Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy (SEAL)
This study is currently recruiting participants.
Verified March 2012 by Association of Urogenital Oncology (AUO)
Sponsor:
Association of Urogenital Oncology (AUO)
Information provided by (Responsible Party):
Association of Urogenital Oncology (AUO)
ClinicalTrials.gov Identifier:
NCT01555086
First received: March 13, 2012
Last updated: March 14, 2012
Last verified: March 2012
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Purpose
This study examines Limited versus extended pelvic lymphadenectomy.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Procedure: Limited pelvic Lymphadenectomy Procedure: Extended pelvic Lymphadenectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy |
Resource links provided by NLM:
Further study details as provided by Association of Urogenital Oncology (AUO):
Primary Outcome Measures:
- PSA-progress [ Time Frame: 5 years ] [ Designated as safety issue: No ]3-monthly Follow-up with PSA-measurement in blood
Secondary Outcome Measures:
- Comparison of overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy
- Comparison of morbidity [ Time Frame: 5 years ] [ Designated as safety issue: No ]Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2011 |
| Estimated Primary Completion Date: | August 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Limited pelvic Lymphadenectomy |
Procedure: Limited pelvic Lymphadenectomy
approximately 10-14 lymph nodes are removed
Other Name: limited pelvic LA
|
| Experimental: Extended pelvic Lymphadenectomy |
Procedure: Extended pelvic Lymphadenectomy
approximately 20 lymph nodes are removed
Other Name: extended pelvic LA
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555086
Locations
| Germany | |
| RWTH Aachen | Recruiting |
| Aachen, Germany, 51074 | |
| Contact: Katja Jünemann 0241/80-36 596 kjuenemann@ukaachen.de | |
| Martiniklinik am UKE | Recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Barbara Klimm 040/74 1058038 klimm@uke.uni-hamburg.de | |
| Krankenhaus Maria Hilf | Recruiting |
| Krefeld, Germany, 47805 | |
| Contact: Borbála Fazekas, Dr. 02151/334-52 42 borbala.fazekas@alexianer-krefeld.de | |
Sponsors and Collaborators
Association of Urogenital Oncology (AUO)
More Information
No publications provided
| Responsible Party: | Association of Urogenital Oncology (AUO) |
| ClinicalTrials.gov Identifier: | NCT01555086 History of Changes |
| Other Study ID Numbers: | AP 55/09 |
| Study First Received: | March 13, 2012 |
| Last Updated: | March 14, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Association of Urogenital Oncology (AUO):
|
Lymphadenectomy Prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013