Back to resultsSalvage Lymph Node Dissection in Prostate Cancer Patients With Recurrence After Radical Prostatectomy
Primary Purpose
Prostate Cancer Recurrent
Status
Active
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Salvage lymph node dissection
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer Recurrent
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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Salvage lymph node dissection
Arm Description
Patients will undergo extended pelvic salvage lymph node dissection
Outcomes
Primary Outcome Measures
The rate of periperative complications within 90 days after surgery
The Prostate specific antigen value after 6 weeks.
Secondary Outcome Measures
Change in Prostate Specific Antigen doubling time
Time until development of castration resistance
Time until development of distant metastasis
Full Information
NCT ID
NCT02974075
First Posted
November 20, 2016
Last Updated
March 14, 2023
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02974075
Brief Title
Salvage Lymph Node Dissection in Prostate Cancer Patients With Recurrence After Radical Prostatectomy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2022 (Actual)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Salvage lymph node dissection
Arm Type
Experimental
Arm Description
Patients will undergo extended pelvic salvage lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
Salvage lymph node dissection
Intervention Description
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
Primary Outcome Measure Information:
Title
The rate of periperative complications within 90 days after surgery
Time Frame
90 days
Title
The Prostate specific antigen value after 6 weeks.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in Prostate Specific Antigen doubling time
Time Frame
2 years
Title
Time until development of castration resistance
Time Frame
2 years
Title
Time until development of distant metastasis
Time Frame
2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahrokh Francois Shariat, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Salvage Lymph Node Dissection in Prostate Cancer Patients With Recurrence After Radical Prostatectomy
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