This trial is active, not recruiting.

Condition prostate cancer
Treatment tumor marker detection in lymph nodes
Sponsor Technische Universität München
Start date February 2010
End date December 2020
Trial size 160 participants
Trial identifier NCT01615965, 2607/09


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Molecular biologic detection of micrometastases in lymph nodes of patients with localized prostate cancer treated with radical prostatectomy and lymphadenectomy.
tumor marker detection in lymph nodes
tumor marker detection in lymph nodes by quantitative PCR

Primary Outcomes

Biochemical recurrence free survival
time frame: 2 years

Secondary Outcomes

Frequency of molecular detected lymph node micrometastases according to their topography
time frame: 2 years

Eligibility Criteria

Male participants from 18 years up to 80 years old.

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

Additional Information

Official title Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Technische Universität München.