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Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tumor marker detection in lymph nodes
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, lymph node, micrometastasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urologic Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

micrometastases

Arm Description

Molecular biologic detection of micrometastases in lymph nodes of patients with localized prostate cancer treated with radical prostatectomy and lymphadenectomy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency of molecular detected lymph node micrometastases according to their topography
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.

Full Information

First Posted
February 27, 2010
Last Updated
July 27, 2015
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01615965
Brief Title
Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer
Official Title
Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, lymph node, micrometastasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
micrometastases
Arm Type
Experimental
Arm Description
Molecular biologic detection of micrometastases in lymph nodes of patients with localized prostate cancer treated with radical prostatectomy and lymphadenectomy.
Intervention Type
Other
Intervention Name(s)
tumor marker detection in lymph nodes
Intervention Description
tumor marker detection in lymph nodes by quantitative PCR
Primary Outcome Measure Information:
Title
Biochemical recurrence free survival
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Frequency of molecular detected lymph node micrometastases according to their topography
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Urologic Department
City
Munich
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.mriu.de
Description
Related Info

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Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

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