Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Feb 2010
Longer than P75 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 27, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 28, 2015
July 1, 2015
10.8 years
February 27, 2010
July 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemical recurrence free survival
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
2 years
Secondary Outcomes (1)
Frequency of molecular detected lymph node micrometastases according to their topography
2 years
Study Arms (1)
micrometastases
EXPERIMENTALMolecular biologic detection of micrometastases in lymph nodes of patients with localized prostate cancer treated with radical prostatectomy and lymphadenectomy.
Interventions
tumor marker detection in lymph nodes by quantitative PCR
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urologic Department
Munich, 81675, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2010
First Posted
June 11, 2012
Study Start
February 1, 2010
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
July 28, 2015
Record last verified: 2015-07