Clinical trial NCT02974075: Salvage Lymph Node Dissection in Prostate Cancer Patients With Recurrence After Radical Prostatectomy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer Recurrent
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 65
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The rate of periperative complications within 90 days after surgery
timeFrame: 90 days
measure: The Prostate specific antigen value after 6 weeks.
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Prostate Specific Antigen doubling time
timeFrame: 2 years
measure: Time until development of castration resistance
timeFrame: 2 years
measure: Time until development of distant metastasis
timeFrame: 2 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Shahrokh Francois Shariat, MD
role: STUDY_CHAIR
References: