Salvage Lymph Node Dissection in Prostate Cancer Patients With Recurrence After Radical Prostatectomy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer Recurrent

Intervention / Treatment
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* Procedure: Salvage lymph node dissection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salvage lymph node dissection<br>Patients will undergo extended pelvic salvage lymph node dissection | Procedure: Salvage lymph node dissection<br>* Open pelvic surgery to dissect pelvic lymph nodes. The landmarks for dissection are: 1. Inferior mesenteric artery 2. Ilioinguinal nerve 3. Inguinal ligament 4. Dorsal pelvic floor 5. Urinary bladder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of periperative complications within 90 days after surgery |  | 90 days | 
| The Prostate specific antigen value after 6 weeks. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |