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

Prostate Cancer Recurrent Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02974075
• Other study ID #: 1460/2016
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: November 2024

Study information

• Verified date: March 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: November 2024
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer Recurrent
• Prostatic Neoplasms
• Recurrence

Intervention

Procedure:
• Salvage lymph node dissection
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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of periperative complications within 90 days after surgery		90 days
Primary	The Prostate specific antigen value after 6 weeks.		6 weeks
Secondary	Change in Prostate Specific Antigen doubling time		2 years
Secondary	Time until development of castration resistance		2 years
Secondary	Time until development of distant metastasis		2 years