Clinical trial · Interventional
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
NCT01555086CI-TRIAL-00025598SEALunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study examines Limited versus extended pelvic lymphadenectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extended pelvic Lymphadenectomy | Procedure | — | UNRESOLVED |
| Limited pelvic Lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Limited pelvic Lymphadenectomy
- interventionNames
- Procedure: Limited pelvic Lymphadenectomy
- type
- EXPERIMENTAL
- label
- Extended pelvic Lymphadenectomy
- interventionNames
- Procedure: Extended pelvic Lymphadenectomy
Primary outcomes (1)
- measure
- PSA-progress
- timeFrame
- 5 years
- description
- 3-monthly Follow-up with PSA-measurement in blood
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.