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

May 29, 2015 updated by: Johann J. Wendler, MD, University of Magdeburg

Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy (RPVE) in Prostate Cancer (PCA) Patients for Molecular Tumor Marker Analysis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Gronau, Nordrhein-Westfalen, Germany, 48599
        • St. Antonius Hospital
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • Department of Urology, University Clinic Otto von Guericke University Magdeburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • surgical biopsies
Procedure: RPVE
Open Radical prostatovesiculectomy in Magdeburg
Other Names:
  • 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 Names:
  • surgical biopsies
Procedure: CE
Open cystectomy in Magdeburg/Gronau
Other Names:
  • surgical cystoprostatectomy
Procedure: biopsies of the prostatic fossa in gronau
intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau
Other Names:
  • surgical biopsies
Active Comparator: PCA Gronau
Prostate cancer conducted for ETRARP with curative Intention, biopsies of the prostatic fossa
Procedure: biopsies of the prostatic fossa in gronau
intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau
Other Names:
  • surgical biopsies
Procedure: ETRARP
Robotassisted Radical prostatovesiculectomy in Gronau
Other Names:
  • surgical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Methylation status of GSTP1
Time Frame: 2 years
Methylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP)
2 years
Histopathology of prostate fossa biopsies
Time Frame: 2 years
Histopathology of prostate fossa biopsies (Prostata cancer positive or negative)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Magdeburg

Collaborators

St. Antonius Hospital Gronau

Investigators

  • Study Chair: Martin Schostak, Prof.Dr.med., University of Magdeburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-URO-00021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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