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Completed

NCT Number: NCT02974075

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

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.

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Key information

Conditions

Prostate Cancer Recurrent

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. The rate of periperative complications within 90 days after surgery

    Time frame: 90 days

  2. The Prostate specific antigen value after 6 weeks.

    Time frame: 6 weeks

Secondary outcomes

  1. Change in Prostate Specific Antigen doubling time

    Time frame: 2 years

  2. Time until development of castration resistance

    Time frame: 2 years

  3. Time until development of distant metastasis

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2022
Study completion
2024
First posted
Nov 28, 2016
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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