Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Technische Universität München
Information provided by (Responsible Party):
Technische Universität München Identifier:
First received: February 27, 2010
Last updated: June 8, 2012
Last verified: June 2012

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.

Condition Intervention
Prostate Cancer
Other: tumor marker detection in lymph nodes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Biochemical recurrence free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Frequency of molecular detected lymph node micrometastases according to their topography [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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.

Estimated Enrollment: 160
Study Start Date: February 2010
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: micrometastases
Molecular biologic detection of micrometastases in lymph nodes of patients with localized prostate cancer treated with radical prostatectomy and lymphadenectomy.
Other: tumor marker detection in lymph nodes
tumor marker detection in lymph nodes by quantitative PCR


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01615965

Contact: Matthias Heck 0049-89-4140-2552

Urologic Department Recruiting
Munich, Germany, 81675
Contact: Matthias Heck    089-4140-2502   
Principal Investigator: Matthias Heck         
Sponsors and Collaborators
Technische Universität München
  More Information

Additional Information:
No publications provided

Responsible Party: Technische Universität München Identifier: NCT01615965     History of Changes
Other Study ID Numbers: 2607/09
Study First Received: February 27, 2010
Last Updated: June 8, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
prostate cancer
lymph node

Additional relevant MeSH terms:
Neoplasm Micrometastasis
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasm Metastasis
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms processed this record on February 27, 2015