Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: tumor marker detection in lymph nodes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: micrometastases<br>Molecular biologic detection of micrometastases in lymph nodes of patients with localized prostate cancer treated with radical prostatectomy and lymphadenectomy. | Other: tumor marker detection in lymph nodes<br>* tumor marker detection in lymph nodes by quantitative PCR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, lymph node, micrometastasis