Salvage lymphadenectomy with or without adjuvant radiation therapy for prostate cancer recurrence

Not Applicable

• Conditions: C61; Prostate Carcinoma, Salvage lymphadenectomy; Malignant neoplasm of prostate

• Registration Number: DRKS00010497
• Lead Sponsor: niversitätsklinikum FreiburgKlinik für Urologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-15
• Study Completion: 2018-12-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

1) capacity and patient compliance;
2) primary therapy prostate cancer (excluding z.n. radical prostatectomy)
3) presence of biochemical recurrence (PSA> 0,2ng/ml in two consecutive measurements at Z.n. radical prostatectomy)
4) Morphological imaging (excluded 68Ga-PSMA-PET / CT) suspencion of lymph node metastases (pelvis up including aortic bifurcation, solitary or multiple)
5) presence of imaging (excluded 68Ga-PSMA-PET / CT) for the diagnosis of lymph node metastasis (= 4 months old)
6) In case of antihormonal therapy these 4 weeks should be discontinued prior to planned salvage lymphadenectomy
7) Hematological, blood coagulation, hepatic and renal functions in the normal range (as part of the routine preparation for surgery)

Exclusion Criteria

1) detection of distant metastases (Soft-tissue metastasis an/or bone metastases and/or visceral metastases, and/or lymph node metastases above the bifurcation)
2)radiotherapy as primary therapy
3) Untreated malignancies or evidence of another tumor, which limits the life expectancy of the patient leader
4) Charlson Comorbidity Index> 2
5) ECOG performance score> 1
6) myocardial infarction or apoplexy within the last 6 months
7) Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or hematopoietic (f.e. severe bone marrow aplasia) disease
8) acute and chronic infection (f.e. HIV Ab test, HBs-Ag detection in serum and / or chronic hepatitis)
9) Severe psychiatric disorders persons housed on judicial or administrative arrangement in an institution
10) Simultaneous participation in another clinical trial with interventional character (simultaneous participation in registry studies and / or non-interventional studies is allowed)
11) Subjects, who are standing in the work relationship / or relationship of dependency with Principal investigator or having any condition which, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PCA Progression-free survival time; Radiological Progression-free survival time

Secondary Outcome Measures

Name	Time	Method
- hormone therapy free survival;<br>- Tumor-specific survival time;<br>- Overall survival;<br>- Drug toleranca, side effects and toxicity of salvage Lymphadenektomy and adjuvant radiation therapy<br>