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

Medical University of Vienna

Status: Active, not recruiting

Conditions: Prostate Cancer Recurrent

Treatments: Procedure: Salvage lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT02974075

1460/2016

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 1 patient group

Salvage lymph node dissection

Experimental group

Description:

Patients will undergo extended pelvic salvage lymph node dissection

Treatment:

Procedure: Salvage lymph node dissection