Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy
NCT ID: NCT02460861
Last Updated: 2015-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
279 participants
INTERVENTIONAL
2011-11-30
2015-12-31
Brief Summary
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The prostate-cancer-negative control group with bladder cancer.
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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PCA Magdeburg
Prostate cancer conducted for RPVE with curative Intention, biopsies of the prostatic fossa in Magdeburg
biopsies of the prostatic fossa in Magdeburg
intraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg
RPVE
Open Radical prostatovesiculectomy in Magdeburg
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
biopsies of the prostatic fossa in Magdeburg
intraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg
CE
Open cystectomy in Magdeburg/Gronau
biopsies of the prostatic fossa in gronau
intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau
PCA Gronau
Prostate cancer conducted for ETRARP with curative Intention, biopsies of the prostatic fossa
ETRARP
Robotassisted Radical prostatovesiculectomy in Gronau
biopsies of the prostatic fossa in gronau
intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau
Interventions
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biopsies of the prostatic fossa in Magdeburg
intraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg
RPVE
Open Radical prostatovesiculectomy in Magdeburg
ETRARP
Robotassisted Radical prostatovesiculectomy in Gronau
CE
Open cystectomy in Magdeburg/Gronau
biopsies of the prostatic fossa in gronau
intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosis: prostate adenocarcinoma
* treatment: radical prostatovesiculectomy
* period of treatment: 11/30/2011 - 10/15/2013
* sex: male
* diagnosis: urothelial carcinoma
* treatment: cysto-prostatectomy
* period of treament: 12/14/2011 - 02/18/2014
Exclusion Criteria
* 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:
* sex: female
* diagnosis: incidental prostate adenocarcinoma
* treatment: no cysto-prostatectomy
* period of treatment: before 12/14/2011 or after 02/18/2014
MALE
No
Sponsors
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St. Antonius Hospital Gronau
OTHER
University of Magdeburg
OTHER
Responsible Party
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Johann J. Wendler, MD
Dr. med.
Principal Investigators
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Martin Schostak, Prof.Dr.med.
Role: STUDY_CHAIR
University of Magdeburg
Locations
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St. Antonius Hospital
Gronau, North Rhine-Westphalia, Germany
Department of Urology, University Clinic Otto von Guericke University Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Countries
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Other Identifiers
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MD-URO-00021
Identifier Type: -
Identifier Source: org_study_id
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