Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Other: tumor marker detection in lymph nodes

• Registration Number: NCT01615965
• Lead Sponsor: Technical University of Munich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-27
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-11
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
micrometastases	tumor marker detection in lymph nodes	Molecular biologic detection of micrometastases in lymph nodes of patients with localized prostate cancer treated with radical prostatectomy and lymphadenectomy.

Primary Outcome Measures

Name	Time	Method
Biochemical recurrence free survival	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 Outcome Measures

Name	Time	Method
Frequency of molecular detected lymph node micrometastases according to their topography	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.

Trial Locations

Locations (1)

Urologic Department; 🇩🇪 Munich, Germany