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

NCT ID: NCT02974075

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2024-11-30

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.

Conditions

Prostate Cancer Recurrent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Salvage lymph node dissection

Patients will undergo extended pelvic salvage lymph node dissection

Group Type: EXPERIMENTAL

Salvage lymph node dissection

Intervention Type: PROCEDURE

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

Interventions

Salvage lymph node dissection

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Bernhard Grubmüller

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shahrokh Francois Shariat, MD

Role: STUDY_CHAIR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

1460/2016

Identifier Type: -

Identifier Source: org_study_id