Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

NCT ID: NCT01615965

Last Updated: 2015-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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micrometastases

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

Group Type EXPERIMENTAL

tumor marker detection in lymph nodes

Intervention Type OTHER

tumor marker detection in lymph nodes by quantitative PCR

Interventions

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tumor marker detection in lymph nodes

tumor marker detection in lymph nodes by quantitative PCR

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urologic Department

Munich, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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2607/09

Identifier Type: -

Identifier Source: org_study_id

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