Large study to investigate MRI prior to biopsy for prostate cancer diagnosis

Posted on June 13, 2011 by Sitemaster

A large study in the United Kingdom ? the PROMIS study ? will shortly start to recruit patients in an attempt to see whether multi-parametric magnetic resonance imaging (MP-MRI) can help find prostate cancer and learn the extent of disease prior to prostate biopsy.

The PROMIS study is expected to recruit > 700 patients and has three primary goals:

• To determine the proportion of men who could safely avoid a prostate biopsy
• To determine the proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer
• To assess the safety of MP-MRI for this application

To be eligible for this clinical trial, patients must meet the following criteria:

• Be men at risk of prostate cancer who have been advised to have a prostate biopsy
• Be suspected to have organ-confined prostate cancer (stage ? T2) on the basis of rectal examination
• Have a serum PSA level ? 15 ng/ml within the preceding 3 months

All study participants will be given a multi-parametric, T2-weighted, diffusion-weighted, and dynamic contrast-enhanced MRI, followed by a template and transrectal ultrasound-guided prostate mapping biopsy. Some patients may also be asked to undergo periodic blood, urine, and tissue sample collection for biomarker studies. Patients will also be asked to complete a quality-of-life questionnaire at baseline, during, and after completion of the study. They will be followed on a periodic basis that depends on the study findings.

We note that an economic analysis is also going to be carried out to assess the cost-effectiveness of this application of MP-MRI.

As far as The ?New? Prostate Cancer InfoLink is aware, this will be the first really large study to formally investigate the accuracy and value of MRI scanning for this potential application. Prior data have largely come from retrospective analysis of case series as opposed to from prospective clinical trials. The trial protocol suggests that data from this study may be available by mid 2013.

Filed under: Diagnosis, Risk Tagged: | biopsy, Diagnosis, magnetic resonance imaging, MRI

Source: http://prostatecancerinfolink.net/2011/06/13/large-study-to-investigate-mri-prior-to-biopsy-for-prostate-cancer-diagnosis

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