Prospective randomized trial to evaluate the prognostic role of lymphnode dissection in men with prostate cancer treated with radical prostatectomy

Not Applicable

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00019941
• Lead Sponsor: Martini-Klinik am UKE GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 1805

Inclusion Criteria

localized intermediate risk prostate cancer (intermediate risk (PSA> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b)
- scheduled for RRP or DVRP

Exclusion Criteria

- ASA (American Society of Anesthesiology) Classification> 3
- Existing contraindications for performing a lymph node dissection
- Neoadjuvant hormone therapy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The PSA recurrence rate in patients with intermediate risk prostate cancer treated with radical prostatectomy with or without additional lymph node dissection at three years of follow up (PSA recurrence: PSA value = 0.2 ng / ml). After amendment, the follow-up is extended to 10 years.

Secondary Outcome Measures

Name	Time	Method
- metastasis-free survival (radiological)<br>- Incidence of lymphoceles and complications 6 months after surgery (Clavien classification)<br>- incidence of adjuvant therapies (salvage LAD, hormone therapy, radiation) functional outcome (quality of life, continence, potency)<br>After amendment, the follow-up is extended to 10 years.