Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00009479

Trial Description

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Title

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

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Trial Acronym

iPROLOGX

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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).

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Organizational Data

  •   DRKS00009479
  •   2015/10/23
  •   2015/05/28
  •   yes
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Secondary IDs

  •   NCT02460861  (ClinicalTrials.gov)
  •   MD-URO-00021  (University of Magdeburg)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Procedure: biopsies of the prostatic fossa in Magdeburg
  •   Procedure: RPVE
  •   Procedure: ETRARP
  •   Procedure: CE
  •   Procedure: biopsies of the prostatic fossa in gronau
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
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Primary Outcome

- Methylation status of GSTP1; time frame: 2 years; Methylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP)
- Histopathology of prostate fossa biopsies; time frame: 2 years; Histopathology of prostate fossa biopsies (Prostata cancer positive or negative)

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/11/30
  •   279
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Inclusion Criteria

  •   Male
  •   no minimum age
  •   no maximum age
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Additional Inclusion 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

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Exclusion Criteria

[---]*

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Addresses

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    • University of Magdeburg
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    • St. Antonius Hospital Gronau
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    • University of Magdeburg
    • Martin Schostak, Prof.Dr.med. 
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    • University of Magdeburg
    • Martin Schostak, Prof.Dr.med. 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.