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Influence of somatic mutational status of DNA repair genes on the clinical course in men with High risk-prostate cancer - a prospective biomarker study

Influence of somatic mutational status of DNA repair genes on the clinical course in men with High risk-prostate cancer - a prospective biomarker study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00015159
Enrollment
200
Registered
2019-02-25
Start date
2017-05-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

High grade prostate carcinoma C61

Interventions

Group 1: Next generation sequencing (NGS) of an extended DNA repair gene panel of paraffin embedded tumor tissue at time of diagnosis (biopsy or prostatectomy). At Initial presentation and at every p

Sponsors

Universitätsklinikum Heidelberg Nationales Centrum für Tumorerkrankungen (NCT) Medizinische Onkologie und Urologische Klinik
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • pre-existing psychiatric disorder • other active malignant diseases • non legally competent or incapacitated patients • patients, who refuse to undergo systemic treatments

Design outcomes

Primary

MeasureTime frame
progression of disease

Secondary

MeasureTime frame
overall survival

Countries

Germany

Contacts

Public ContactCathleen Nientiedt

Universitätsklinikum Heidelberg Nationales Centrum für Tumorerkrankungen (NCT) Medizinische Onkologie

Cathleen.Nientiedt@med.uni-heidelberg.de06221-5632845

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026