Clinical trial · Interventional
Salvage Lymph Node Dissection in Prostate Cancer Patients With Recurrence After Radical Prostatectomy
Safety and Efficacy of Salvage Lymph Node Dissection in Prostate Cancer Patients With Nodal Recurrence After Radical Prostatectomy With Curative Intent - a Prospective Single Center Phase I/II Study
- 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)
Despite continuous technical improvements in urologic surgery, up to 40% of prostate cancer patients will develop biochemical recurrence after radical prostatectomy (RP), potentially because of micro metastasis at the time of the primary surgery. With improved radiological modalities and nuclear medicine tracers like 68Ga-PSMA PET/CT, which allow the localization of the site of recurrence, there is increasing interest in metastasis directed therapies, such as salvage lymph node dissection. The pelvic extended salvage lymph node dissection (sLND) is a promising option for treating prostate cancer patients with local recurrence after radical prostatectomy with curative intent. Several retrospective series has been published to determine the local value of sLND. Despite the first data seem to be feasible and promising, to date no prospective evaluation has been made. Thus sLND is still experimental according to the guidelines and is considered as an off label therapy. This prospective single center phase I/II study was conducted to investigate the safety and early efficacy of salvage lymph node dissection in prostate cancer patients with local pelvic recurrence after radical prostatectomy (RP) with curative intention.
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 Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Salvage lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Salvage lymph node dissection
- description
- Patients will undergo extended pelvic salvage lymph node dissection
- interventionNames
- Procedure: Salvage lymph node dissection
Primary outcomes (2)
- measure
- The rate of periperative complications within 90 days after surgery
- timeFrame
- 90 days
- measure
- The Prostate specific antigen value after 6 weeks.
- timeFrame
- 6 weeks
Secondary outcomes (3)
- measure
- Change in Prostate Specific Antigen doubling time
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer patients with lymph node metastasis in pelvic imaging * Status post radical prostatectomy with curative intent * Ability for informed consent * No sign for bone or visceral metastasis * Male \> 18 years * ECOG performance status 0 or 1 Exclusion Criteria: * Male \< 18 years * No ability for informed consent * Sign for bone or visceral metastasis * Deep venous thrombosis or pulmonary embolism within the last 6 months before study screening * ECOG performance status 2 or more
References
Publications (0)
Data not yet available