NCT02974075Completed
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 · Last updated 14 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 20 Nov 2016
- Start date
- Aug 2016
- Primary completion date
- Nov 2022
- Lead sponsor
- Medical University of Vienna
- Diseases
- Prostate cancer
- NCT number
- NCT02974075
What you commit to
- Study type: Interventional
- Participants enrolled: 65
- From Aug 2016 to the primary completion date, Nov 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Deep venous thrombosis or pulmonary embolism within the last 6 months before study screening
Age
- Male \< 18 years
Other
- No ability for informed consent
- Sign for bone or visceral metastasis
- ECOG performance status 2 or more
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.