Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01615965

Enrollment

160

Registered

2012-06-11

Start date

2010-02-28

Completion date

2021-12-31

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, lymph node, micrometastasis

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.

Interventions

OTHERtumor marker detection in lymph nodes

tumor marker detection in lymph nodes by quantitative PCR

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Biochemical recurrence free survival	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

Measure	Time frame	Description
Frequency of molecular detected lymph node micrometastases according to their topography	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

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026