Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments biopsies of the prostatic fossa in magdeburg, rpve, etrarp, ce, biopsies of the prostatic fossa in gronau
Sponsor University of Magdeburg
Collaborator St. Antonius Hospital Gronau
Start date November 2011
End date October 2013
Trial size 279 participants
Trial identifier NCT02460861, MD-URO-00021

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
Prostate cancer conducted for RPVE with curative Intention, biopsies of the prostatic fossa in Magdeburg
biopsies of the prostatic fossa in magdeburg surgical biopsies
intraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg
rpve surgical prostatectomy
Open Radical prostatovesiculectomy in Magdeburg
(Active Comparator)
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
biopsies of the prostatic fossa in magdeburg surgical biopsies
intraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg
ce surgical cystoprostatectomy
Open cystectomy in Magdeburg/Gronau
biopsies of the prostatic fossa in gronau surgical biopsies
intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau
(Active Comparator)
Prostate cancer conducted for ETRARP with curative Intention, biopsies of the prostatic fossa
etrarp surgical prostatectomy
Robotassisted Radical prostatovesiculectomy in Gronau
biopsies of the prostatic fossa in gronau surgical biopsies
intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau

Primary Outcomes

Measure
Methylation status of GSTP1
time frame: 2 years
Histopathology of prostate fossa biopsies
time frame: 2 years

Eligibility Criteria

Male participants of any age.

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 Exclusion Criteria - 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

Additional Information

Official title Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy (RPVE) in Prostate Cancer (PCA) Patients for Molecular Tumor Marker Analysis
Description 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 DNA was modified by using EpiTect Bisulfite Kit (QIAGEN, Hilden, Germany) according to manufacturer's instructions. Samples were eluted once with 20 µl elution buffer. QUANTITATIVE METHYLATION SPECIFIC PCR Methylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP) using StepOnePlus Real-Time PCR System and StepOne Software v2.1 from Applied Biosystems (Darmstadt, Germany). Q-MSP was performed in duplicate analysing genes Actin and GSTP1. The primers' and testing probes' sequences used to amplify and detect hypermethylated GSTP1 were: 5'-AgTTgCgCggCgATTTC (forward primer), 5'-gCCCCAATACTAAATCACgACg (reverse primer) and 5'-CggTCgACgTTCggggTgTAgCg (taqman probe), labelled with fluorescence dye FAM. The primers' and testing probes' sequences used to amplify and detect Actin were: 5'-TggTgATggAggAggTTTAgTAAgT (forward primer), 5'-AACCAATAAAACCTACTCCTCCCTTAA (reverse primer),5'-ACCACCACCCAACACACAATAACAAACACA (taqman probe), labelled with fluorescence dye VIC. The Q-MSP was carried out at 50°C for 2 min., 95°C for 15 min. followed by 50 cycles of 95°C for 1s and 60°C for 1 min. As a positive control bisulfite-converted DNA of DU145 and LNCap were used. Blank reactions with destillated water, which replaced DNA, served as negative control (NTC).
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Magdeburg.