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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33366

Enrollment

Registered

2009-10-05

Start date

2010-06-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

to localize prostate cancer within the prostate

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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: a) focal areas of low signal intensity on T2-weighted images; b) 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; c) the extent and degree of apparent diffusion coefficient reduction on DWI; d) the extent and degree of perfusion abnormality on DCE-MRI; with the presence or absence of cancer at (reconstructed) whole mount section histopathology. Hypothesis: 3-Tesla multi-modality non-ERC MR will localize prostate cancer with an accuracy of 85%.	—

Measure

Time frame

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: a) focal areas of low signal intensity on T2-weighted images; b) 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; c) the extent and degree of apparent diffusion coefficient reduction on DWI; d) the extent and degree of perfusion abnormality on DCE-MRI; with the presence or absence of cancer at (reconstructed) whole mount section histopathology. Hypothesis: 3-Tesla multi-modality non-ERC MR will localize prostate cancer with an accuracy of 85%.

—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results