Prostate CancerPCa-MAPNCT01138527
Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach
An observational study of Prostate Cancer, run by Radboud University Medical Center at 9 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI examination
- How many people
- 148 participants
- Where
- 9 sitesin 8 countries
- Study dates
- Jun 2010to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Biopsy-proven patients with prostate cancer, planned for radical prostatectomy.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 8 countries.
9 sites in 8 countries
United States2 sites
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Germany1 site
University Medical Center Mannheim, Heidelberg University
Mannheim
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6525GA
United Kingdom1 site
Mount Vernon Hospital, Paul Strickland Scanner Centre
London
About this study
Official title: Prostate Cancer Localization With a Multiparametric MR Approach
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.
Read the detailed description
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:
- focal areas of low signal intensity on T2-weighted images;
- 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;
- the extent and degree of apparent diffusion coefficient reduction on DWI;
- 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.
- Conditions
- Prostate Cancer
- Being tested
- MRI examination
- Keywords
- multi-parametric MRI approach
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examinationOther
45-minute MRI examination of the prostate and surrounding tissues with T2-weighted MRI, diffusion-weighted MRI, Spectroscopic Imaging and dynamic contrast enhanced imaging
| Study group | Role | What they receive |
|---|---|---|
| Biopsy-proven prostate cancer | Patients with biopsy-proven prostate cancer, planned for radical prostatectomy Receives: Other: MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate
Measured: December 2015
Secondary outcomes (1)
Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer
Measured: december 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2015
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens AG, Mount Vernon Hospital, Multi-Imagem and CDPI, Rio de Janeiro, Brasil, Norwegian University of Science and Technology, University of California, Los Angeles, University Hospital, Ghent, Johns Hopkins University, Medical University of Vienna, University Health Network, Toronto, Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Tom W Scheenen, PhD, Principal investigator, Radiology, Radboud University Nijmegen Medical CentreJurgen J Fütterer, MD PhD, Principal investigator, Radiology, Radboud University Nijmegen Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138527
- Sponsor's protocol ID
- RU PCa-MAP
- Acronym
- PCa-MAP
- Status last verified
- Sep 2018
- First submitted
- 4 Jun 2010
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Localization With a Multiparametric MR Approach
- ClinicalTrials.gov ID
- NCT01138527
- Acronym / sponsor ID
- PCa-MAP / RU PCa-MAP
- Conditions
- Prostate Cancer
- Keywords
- multi-parametric MRI approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Siemens AG, Mount Vernon Hospital, Multi-Imagem and CDPI, Rio de Janeiro, Brasil, Norwegian University of Science and Technology, University of California, Los Angeles, University Hospital, Ghent, Johns Hopkins University, Medical University of Vienna, University Health Network, Toronto, Heidelberg University
- Study start
- Jun 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- focal areas of low signal intensity on T2-weighted images;
- 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;
- the extent and degree of apparent diffusion coefficient reduction on DWI;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy-proven prostate cancer | – | Other: MRI examinationPatients with biopsy-proven prostate cancer, planned for radical prostatectomy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Biopsy-proven patients with prostate cancer, planned for radical prostatectomy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI examination45-minute MRI examination of the prostate and surrounding tissues with T2-weighted MRI, diffusion-weighted MRI, Spectroscopic Imaging and dynamic contrast enhanced imaging | Other | Biopsy-proven prostate cancer |
Primary outcome
Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate
Time frame: December 2015
1 secondary outcome
Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer
Time frame: december 2015
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom W Scheenen, PhD principal investigator
Radiology, Radboud University Nijmegen Medical Centre
Jurgen J Fütterer, MD PhD principal investigator
Radiology, Radboud University Nijmegen Medical Centre
9 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Radboud University Medical Center at 9 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Austria, Belgium, Canada, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate (time frame: December 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.