Trial document





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

  DRKS00004124

Trial Description

start of 1:1-Block title

Title

Prostate Cancer Localization With a Multiparametric MR Approach

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PCa-MAP

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The primary objective of this prospective multi-centre study is to prove the diagnostic
accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution
T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other
prostate tissue. The gold standard for distinguishing the tissue types is the analysis of
whole-mount sections of the resected prostate by a genitourinary histopathologist.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Goal Proving that multi-parametric MR imaging in a multi-centre setting allows for
localizing clinically significant (volume > 0.5cc; Gleason > 6) prostate carcinoma in the
prostate.

Objective 1

To determine the diagnostic accuracy (area under the receiver-operating characteristic
curve) of 3-Tesla multi-modality non-endorectal coil (ERC) MR imaging in localizing prostate
cancer, by correlating:

1. focal areas of low signal intensity on T2-weighted images;

2. the extent and degree of deviating metabolite ratios derived from MRSI. This can be the
choline+creatine/citrate ratio or if possible, the choline / citrate ratio;

3. the extent and degree of apparent diffusion coefficient reduction on DWI;

4. the extent and degree of perfusion abnormality on DCE-MRI; with the presence or absence
of cancer at (reconstructed) whole mount section histopathology.

Objective 2 Proving that multi-modality MR data allows for predicting tumor grade. The
parameters from the different MR methods for a tumor focus can be correlated to the local
Gleason grade of the corresponding lesion in the histopathological specimens.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004124
  •   2012/10/11
  •   2010/06/04
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01138527  (ClinicalTrials.gov)
  •   RU PCa-MAP  (Radboud University)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Other: MRI examination
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate; time frame: December 2015

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer; time frame: december 2015

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Austria
  •   Belgium
  •   Canada
  •   Germany
  •   Netherlands
  •   Norway
  •   United Kingdom
  •   United States
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2010/06/30
  •   150
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Biopsy-proven diagnosis of adenocarcinoma of the prostate

- Subject will sign a consent form prior to study entry

- Radical prostatectomy and histopathological exam planned

- The time interval between last biopsy and the MR exam must be at least 4 weeks

- The time interval between MR exam and radical prostatectomy should not exceed 12
weeks

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Subjects who are unable to give valid informed consent

- Subjects who are unwilling or unable to undergo an MR exam, including subjects with
contra-indications to MR exams

- Therapy or surgical procedure applied to the prostate or to other organs in vicinity
to the prostate: among the therapies preventing inclusion are any form of radiation
therapy, cryo-therapy, thermal-therapy, therapy based on any other medication
(including hormonal therapy).

- Patients under hormone deprivation therapy.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Radboud University
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Siemens AG
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Mount Vernon Hospital
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Multi-Imagem and CDPI, Rio de Janeiro, Brasil
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Norwegian University of Science and Technology
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • University of California, Los Angeles
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • University Hospital, Ghent
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Johns Hopkins University
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Medical University of Vienna
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • University Health Network, Toronto
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Heidelberg University
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Radiology, Radboud University Nijmegen Medical Centre
    • Tom W Scheenen, PhD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Radiology, Radboud University Nijmegen Medical Centre
    • Tom W Scheenen, PhD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

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
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
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 .
  •   6
  •   2016/01/14


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