Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy (iPROLOGX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02460861
Recruitment Status : Unknown
Verified May 2015 by Johann J. Wendler, MD, University of Magdeburg.
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2015
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
St. Antonius Hospital Gronau
Information provided by (Responsible Party):
Johann J. Wendler, MD, University of Magdeburg

Brief 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: biopsies of the prostatic fossa in Magdeburg Procedure: RPVE Procedure: ETRARP Procedure: CE Procedure: biopsies of the prostatic fossa in gronau Not Applicable

Detailed 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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy (RPVE) in Prostate Cancer (PCA) Patients for Molecular Tumor Marker Analysis
Study Start Date : November 2011
Actual Primary Completion Date : October 2013
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PCA Magdeburg
Prostate cancer conducted for RPVE with curative Intention, biopsies of the prostatic fossa in Magdeburg
Procedure: biopsies of the prostatic fossa in Magdeburg
intraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg
Other Name: surgical biopsies

Procedure: RPVE
Open Radical prostatovesiculectomy in Magdeburg
Other Name: surgical prostatectomy

Active Comparator: 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
Procedure: biopsies of the prostatic fossa in Magdeburg
intraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg
Other Name: surgical biopsies

Procedure: CE
Open cystectomy in Magdeburg/Gronau
Other Name: surgical cystoprostatectomy

Procedure: biopsies of the prostatic fossa in gronau
intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau
Other Name: surgical biopsies

Active Comparator: PCA Gronau
Prostate cancer conducted for ETRARP with curative Intention, biopsies of the prostatic fossa
Procedure: ETRARP
Robotassisted Radical prostatovesiculectomy in Gronau
Other Name: surgical prostatectomy

Procedure: biopsies of the prostatic fossa in gronau
intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau
Other Name: surgical biopsies




Primary Outcome Measures :
  1. Methylation status of GSTP1 [ Time Frame: 2 years ]
    Methylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP)

  2. Histopathology of prostate fossa biopsies [ Time Frame: 2 years ]
    Histopathology of prostate fossa biopsies (Prostata cancer positive or negative)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460861


Locations
Layout table for location information
Germany
St. Antonius Hospital
Gronau, Nordrhein-Westfalen, Germany, 48599
Department of Urology, University Clinic Otto von Guericke University Magdeburg
Magdeburg, Sachsen-Anhalt, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
St. Antonius Hospital Gronau
Investigators
Layout table for investigator information
Study Chair: Martin Schostak, Prof.Dr.med. University of Magdeburg

Layout table for additonal information
Responsible Party: Johann J. Wendler, MD, Dr. med., University of Magdeburg
ClinicalTrials.gov Identifier: NCT02460861     History of Changes
Other Study ID Numbers: MD-URO-00021
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: May 2015

Keywords provided by Johann J. Wendler, MD, University of Magdeburg:
Prostate Cancer
Molecular staging
GSTP1
Surgical margins
prostatovesiculectomy

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases