Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01615965
• Other study ID #: 2607/09
• Status: Active, not recruiting
• Phase: N/A
• First received: February 27, 2010
• Last updated: July 27, 2015
• Start date: February 2010
• Est. completion date: December 2021

Study information

• Verified date: July 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• tumor marker detection in lymph nodes
tumor marker detection in lymph nodes by quantitative PCR

Locations

Country	Name	City	State
Germany	Urologic Department	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	2 years	No

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