NCT02460861

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
279

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

May 1, 2015

Enrollment Period

1.9 years

First QC Date

May 28, 2015

Last Update Submit

May 29, 2015

Conditions

Prostate Cancer

Keywords

Prostate CancerMolecular stagingGSTP1Surgical marginsprostatovesiculectomy

Outcome Measures

Primary Outcomes (2)

  • Methylation status of GSTP1

    Methylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP)

    2 years

  • Histopathology of prostate fossa biopsies

    Histopathology of prostate fossa biopsies (Prostata cancer positive or negative)

    2 years

Study Arms (3)

PCA Magdeburg

ACTIVE COMPARATOR

Prostate cancer conducted for RPVE with curative Intention, biopsies of the prostatic fossa in Magdeburg

Procedure: biopsies of the prostatic fossa in MagdeburgProcedure: RPVE

Non-prostate cancer Magdeburg/Gronau

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

Procedure: biopsies of the prostatic fossa in MagdeburgProcedure: CEProcedure: biopsies of the prostatic fossa in gronau

PCA Gronau

ACTIVE COMPARATOR

Prostate cancer conducted for ETRARP with curative Intention, biopsies of the prostatic fossa

Procedure: ETRARPProcedure: biopsies of the prostatic fossa in gronau

Interventions

biopsies of the prostatic fossa in MagdeburgPROCEDURE

intraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg

Also known as: surgical biopsies
Non-prostate cancer Magdeburg/GronauPCA Magdeburg
RPVEPROCEDURE

Open Radical prostatovesiculectomy in Magdeburg

Also known as: surgical prostatectomy
PCA Magdeburg
ETRARPPROCEDURE

Robotassisted Radical prostatovesiculectomy in Gronau

Also known as: surgical prostatectomy
PCA Gronau
CEPROCEDURE

Open cystectomy in Magdeburg/Gronau

Also known as: surgical cystoprostatectomy
Non-prostate cancer Magdeburg/Gronau
biopsies of the prostatic fossa in gronauPROCEDURE

intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau

Also known as: surgical biopsies
Non-prostate cancer Magdeburg/GronauPCA Gronau

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • sex: male
  • diagnosis: prostate adenocarcinoma
  • treatment: radical prostatovesiculectomy
  • period of treatment: 11/30/2011 - 10/15/2013

You may not qualify if:

  • 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:
  • sex: male
  • diagnosis: urothelial carcinoma
  • treatment: cysto-prostatectomy
  • period of treament: 12/14/2011 - 02/18/2014
  • sex: female
  • diagnosis: incidental prostate adenocarcinoma
  • treatment: no cysto-prostatectomy
  • period of treatment: before 12/14/2011 or after 02/18/2014

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Antonius Hospital

Gronau, North Rhine-Westphalia, 48599, Germany

Location

Department of Urology, University Clinic Otto von Guericke University Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

MeSH Terms

Conditions

Prostatic NeoplasmsMargins of Excision

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesMorphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Schostak, Prof.Dr.med.

    University of Magdeburg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 3, 2015

Study Start

November 1, 2011

Primary Completion

October 1, 2013

Study Completion

December 1, 2015

Last Updated

June 3, 2015

Record last verified: 2015-05

Locations

DE(2)