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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
279

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Magdeburg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
St. Antonius Hospital Gronau

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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