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

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer Recurrent
• Interventions: Procedure: Salvage lymph node dissection

• Registration Number: NCT02974075
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-11-20
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-28
• Primary Completion: 2022-11
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Salvage lymph node dissection	Salvage lymph node dissection	Patients will undergo extended pelvic salvage lymph node dissection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria