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临床试验/DRKS00015159
DRKS00015159已完成不适用

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

niversitätsklinikum Heidelberg Nationales Centrum für Tumorerkrankungen (NCT) Medizinische Onkologie und Urologische Klinik0 个研究点目标入组 197 人开始时间: 2019年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
197

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
one 至 one(—)
性别
Male

入选标准

  • 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

排除标准

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

研究者

发起方
niversitätsklinikum Heidelberg Nationales Centrum für Tumorerkrankungen (NCT) Medizinische Onkologie und Urologische Klinik

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