Clinical trial · Interventional
Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer
NCT01615965CI-TRIAL-00018678unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tumor marker detection in lymph nodes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- micrometastases
- description
- Molecular biologic detection of micrometastases in lymph nodes of patients with localized prostate cancer treated with radical prostatectomy and lymphadenectomy.
- interventionNames
- Other: tumor marker detection in lymph nodes
Primary outcomes (1)
- measure
- Biochemical recurrence free survival
- timeFrame
- 2 years
- 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
Secondary outcomes (1)
- measure
- Frequency of molecular detected lymph node micrometastases according to their topography
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.