Influence of somatic mutational status of DNA repair genes on the clinical course in men with High risk-prostate cancer - a prospective biomarker study
- Conditions
- High grade prostate carcinomaC61Malignant neoplasm of prostate
- Registration Number
- DRKS00015159
- Lead Sponsor
- niversitätsklinikum Heidelberg Nationales Centrum für Tumorerkrankungen (NCT) Medizinische Onkologie und Urologische Klinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 197
• Histological subtype: adenocarcinoma of the prostate without neuroendocrine differentiation
• age at disease onset =50 years and/or
• M1 (primary metastasized; every Gleason score, every T, every N, every M) and/or
• Gleason Score 9 or 10 (every T, every M) and/or
• Gleason Score 8 in combination with =pT3 or N1 or PSA =20 ng/ml and/or
• early tumor recurrence or persistence after local therapy (Prostatectomy or Radiotherapy of the prostate) within =12 months and with high PSA doubling time of =3 months and/or
• early development of castrations resistance of the prostate cancer under first line treatment with ADT alone or combination of ADT with Docetaxel or Abiraterone
• no contraindication for approved treatments
• ECOG: 0-1
• availability of tumor tissue in good quality for DNA sequencing
• Complete clinical documentation (PSA at diagnosis, histology, Gleason Score, TNM-Score, course of treatment, course of PSA, radiological reports of all scans since the time of diagnosis
• pre-existing psychiatric disorder
• other active malignant diseases
• non legally competent or incapacitated patients
• patients, who refuse to undergo systemic treatments
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression of disease
- Secondary Outcome Measures
Name Time Method overall survival