Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

Interventions

  • Other: tumor marker detection in lymph nodes
    • tumor marker detection in lymph nodes by quantitative PCR

Arms, Groups and Cohorts

  • Experimental: micrometastases
    • Molecular biologic detection of micrometastases in lymph nodes of patients with localized prostate cancer treated with radical prostatectomy and lymphadenectomy.

Clinical Trial Outcome Measures

Primary Measures

  • Biochemical recurrence free survival
    • Time Frame: 2 years
    • 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

Secondary Measures

  • Frequency of molecular detected lymph node micrometastases according to their topography
    • Time Frame: 2 years
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Technical University of Munich
  • Provider of Information About this Clinical Study
    • Sponsor

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