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Prostate Cancer localization with a Multiparametric MR Approach - PCa-MAP

Recruiting
Conditions
to localize prostate cancer within the prostate
10036958
Registration Number
NL-OMON33366
Lead Sponsor
niversitair Medisch Centrum Sint Radboud
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

• Patients with biopsy-proven diagnosis of adenocarcinoma of the prostate
• Radical prostatectomy and histopathological exam planned

Exclusion Criteria

• Patients who are 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 prostat

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To determine the diagnostic accuracy (area under the receiver-operating<br /><br>characteristic curve) of 3-Tesla multi-modality non-endorectal coil (ERC) MR<br /><br>imaging in localizing prostate cancer, by correlating:<br /><br>a) focal areas of low signal intensity on T2-weighted images;<br /><br>b) the extent and degree of deviating metabolite ratios derived from MRSI. This<br /><br>can be the choline+creatine/citrate ratio or if possible, the choline / citrate<br /><br>ratio;<br /><br>c) the extent and degree of apparent diffusion coefficient reduction on DWI;<br /><br>d) the extent and degree of perfusion abnormality on DCE-MRI;<br /><br>with the presence or absence of cancer at (reconstructed) whole mount section<br /><br>histopathology.<br /><br><br /><br>Hypothesis: 3-Tesla multi-modality non-ERC MR will localize prostate cancer<br /><br>with an accuracy of 85%.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Proving that multi-modality MR data allows for predicting tumor grade.<br /><br>The parameters from the different MR methods for a tumor focus can be<br /><br>correlated to the local Gleason grade of the corresponding lesion in the<br /><br>histopathological specimens. </p><br>
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