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

NCT02974075 | Completed

• 1 other identifier: 1460/2016
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• The rate of periperative complications within 90 days after surgery

  90 days

• The Prostate specific antigen value after 6 weeks.

  6 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Salvage lymph node dissection

EXPERIMENTAL

Patients will undergo extended pelvic salvage lymph node dissection

Procedure: Salvage lymph node dissection

Interventions

Salvage lymph node dissection 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

Salvage lymph node dissection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Study Officials

• Shahrokh Francois Shariat, MD

  Medical University of Vienna

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 20, 2016
• First Posted: November 28, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

AU (1)