Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Technical University of Munich

Status: Unknown

Conditions: Prostate Cancer

Treatments: Other: tumor marker detection in lymph nodes

Study type: Interventional

Funder types: Other

Identifiers

NCT01615965

2607/09

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

micrometastases

Experimental group

Description:

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

Treatment:

Other: tumor marker detection in lymph nodes