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
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01615965
First received: February 27, 2010
Last updated: June 8, 2012
Last verified: June 2012

February 27, 2010
June 8, 2012
February 2010
December 2020   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01615965 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer
Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
Other: tumor marker detection in lymph nodes
tumor marker detection in lymph nodes by quantitative PCR
Experimental: micrometastases
Molecular biologic detection of micrometastases in lymph nodes of patients with localized prostate cancer treated with radical prostatectomy and lymphadenectomy.
Intervention: Other: tumor marker detection in lymph nodes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 2021
December 2020   (final data collection date for primary outcome measure)

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
Male
18 Years to 80 Years
No
Contact: Matthias Heck 0049-89-4140-2552 m.heck@lrz.tum.de
Germany
 
NCT01615965
2607/09
No
Technische Universität München
Technische Universität München
Not Provided
Not Provided
Technische Universität München
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP