Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy (RPVE) in Prostate Cancer (PCA) Patients for Molecular Tumor Marker Analysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 279
- 试验地点
- 2
- 主要终点
- Histopathology of prostate fossa biopsies
研究概览
简要总结
This project is about the detection of occult tumor cells in surgical margins of radical prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1 (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic fossa. The biopsies are divided into two parts. One part used for histopathological analysis and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor stage, Gleason Score and prostate specific antigen (PSA).
The prostate-cancer-negative control group with bladder cancer.
详细描述
This project is about the detection of occult tumor cells in surgical margins of radical prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1 (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic fossa. The biopsies are divided into two parts. One part used for histopathological analysis and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor stage, Gleason Score and prostate specific antigen (PSA).
The prostate-cancer-negative control group with bladder cancer.
DNA ISOLATION
DNA from biopsies stored by -80°C was isolated by using innuPREP DNA mini Kit (Analytik Jena, Jena, Germany) following protocol 1 of the manufacturer's instructions. DNA was eluted with 50 µl elution buffer. Concentration and purity were analysed by using Nanodrop 2000.
DNA BISULFITE MODIFICATION
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Criteria for patients with prostate adenocarcinoma:
- •Inclusion Criteria
- •sex: male
- •diagnosis: prostate adenocarcinoma
- •treatment: radical prostatovesiculectomy
- •period of treatment: 11/30/2011 - 10/15/2013
排除标准
- •sex: female
- •diagnosis: no prostate adenocarcinoma
- •treatment: no radical prostatovesiculectomy
- •period of treament: before 11/30/2011 or after 10/15/2013
- •Criteria for prostate adenocarcinoma negative control group:
- •Inclusion Criteria
- •sex: male
- •diagnosis: urothelial carcinoma
- •treatment: cysto-prostatectomy
- •period of treament: 12/14/2011 - 02/18/2014
- •Exclusion Criteria
- •sex: female
- •diagnosis: incidental prostate adenocarcinoma
- •treatment: no cysto-prostatectomy
- •period of treatment: before 12/14/2011 or after 02/18/2014
研究组 & 干预措施
PCA Magdeburg
Prostate cancer conducted for RPVE with curative Intention, biopsies of the prostatic fossa in Magdeburg
干预措施: biopsies of the prostatic fossa in Magdeburg (Procedure)
PCA Magdeburg
Prostate cancer conducted for RPVE with curative Intention, biopsies of the prostatic fossa in Magdeburg
干预措施: RPVE (Procedure)
Non-prostate cancer Magdeburg/Gronau
Conducted for CE in Male with bladder cancer or other indication for cystectomy but without prostate cancer in Magdeburg or Gronau, biopsies of the prostatic fossa in Gronau
干预措施: biopsies of the prostatic fossa in Magdeburg (Procedure)
Non-prostate cancer Magdeburg/Gronau
Conducted for CE in Male with bladder cancer or other indication for cystectomy but without prostate cancer in Magdeburg or Gronau, biopsies of the prostatic fossa in Gronau
干预措施: biopsies of the prostatic fossa in gronau (Procedure)
PCA Gronau
Prostate cancer conducted for ETRARP with curative Intention, biopsies of the prostatic fossa
干预措施: ETRARP (Procedure)
PCA Gronau
Prostate cancer conducted for ETRARP with curative Intention, biopsies of the prostatic fossa
干预措施: biopsies of the prostatic fossa in gronau (Procedure)
Non-prostate cancer Magdeburg/Gronau
Conducted for CE in Male with bladder cancer or other indication for cystectomy but without prostate cancer in Magdeburg or Gronau, biopsies of the prostatic fossa in Gronau
干预措施: CE (Procedure)
结局指标
主要结局
Histopathology of prostate fossa biopsies
时间窗: 2 years
Histopathology of prostate fossa biopsies (Prostata cancer positive or negative)
Methylation status of GSTP1
时间窗: 2 years
Methylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP)
次要结局
未报告次要终点
研究者
Johann J. Wendler, MD
Dr. med.
University of Magdeburg