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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer Recurrent
- Sponsor
- Medical University of Vienna
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- The rate of periperative complications within 90 days after surgery
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Dr. Bernhard Grubmüller
MD
Medical University of Vienna
Eligibility Criteria
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
Outcomes
Primary Outcomes
The rate of periperative complications within 90 days after surgery
Time Frame: 90 days
The Prostate specific antigen value after 6 weeks.
Time Frame: 6 weeks
Secondary Outcomes
- Change in Prostate Specific Antigen doubling time(2 years)
- Time until development of castration resistance(2 years)
- Time until development of distant metastasis(2 years)