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Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer


N/A
18 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Biochemical recurrence free survival

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

Germany: Ethics Commission

Study ID:

2607/09

NCT ID:

NCT01615965

Start Date:

February 2010

Completion Date:

December 2021

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • lymph node
  • micrometastasis
  • Prostatic Neoplasms

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