Trial document
This study has been imported from ClinicalTrials.gov without additional data checks.
DRKS00006418
Trial Description
Title
Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer
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.
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)
Health Condition or Problem studied
- Prostate Cancer
- C61 - Malignant neoplasm of prostate
Interventions/Observational Groups
- Other: tumor marker detection in lymph nodes
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
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.
Countries of Recruitment
- Germany
Locations of Recruitment
Recruitment
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- 2010/02/27
- 160
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Inclusion Criteria
- Male
- 18 Years
- 80 Years
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
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
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
- 4
- 2016/01/14
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