Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Technical University of Munich160 enrolled

Overview

The purpose of this study is to set up a model for detecting micrometastases in Lymph nodes of patients with prostate cancer by quantitative polymerase chain reaction and its impact on progression-free survival.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

160

Conditions

Prostate Cancer

Interventions

tumor marker detection in lymph nodesOTHER

tumor marker detection in lymph nodes by quantitative PCR

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed prostate cancer * Locally operable tumor * Negative bone scan (obligatory if Gleason Score \> 7 or PSA \> 20ng/ml * Karnofsky ≥ 80% * Age 18 - 75 years * Informed consent in written form * Sufficient hematologic, coagulatory and renal function * Compliant patient and geographic precondition for adequate follow-up given Exclusion Criteria: * Manifest secondary tumor * Organ metastases on CT-scan /MRI or in Histology * Myocardial infarction or stroke within the last 6 months * Severe cardiovascular (Grade III - IV according to NYHA), pulmonary (pO2 \< 60 mmHg), renal, hepatic oder hematopoetic impairment * Severe active or chronic infection (z.B. pos. HIV-Antibody-Test, HBs-Ag-detected in Serum and/ or chronic Hepatitis) * Severe psychiatric disease * Previous chemotherapy * Previous pelvine radiotherapy

Locations (1)

Urologic Department

Munich, Germany

Outcomes

Primary Outcomes

Biochemical recurrence free survival

Influence of molecularbiologic micrometastases in lymph nodes on biochemical recurrence free survival in comparison with patients who have histopathologic macrometastases or no evidence of lymph node metastases

Time frame: 2 years

Secondary Outcomes

Frequency of molecular detected lymph node micrometastases according to their topography

Description of the anatomic distribution of molecularbiologic lymph node micrometastases in prostate cancer patients treated with radical prostatectomy and extended lymphadenectomy. The frequency of molecular detected lymph node micrometastases according to their anatomic distribution at the obturatoric fossa, external iliac, internal iliac and common iliac arteries´ region will be reported.

Time frame: 2 years

Data from ClinicalTrials.gov

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