Trial document




This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006418

Trial Description

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Title

Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006418
  •   2014/11/19
  •   2010/02/27
  •   yes
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Secondary IDs

  •   NCT01615965  (ClinicalTrials.gov)
  •   2607/09  (Technische Universität München)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Other: tumor marker detection in lymph nodes
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
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Primary Outcome

- Biochemical recurrence free survival; time frame: 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

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Secondary Outcome

- Frequency of molecular detected lymph node micrometastases according to their topography; time frame: 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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2010/02/27
  •   160
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Inclusion Criteria

  •   Male
  •   18   Years
  •   80   Years
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Additional 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

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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

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Addresses

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    • Technische Universität München
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.