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

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.

3 Responses

  1. Another step in the right direction. MRI could also be used to better position biopsy needles if determined necessary.

  2. I just wanted to share something here.

    I do not have the report in front of me to give you the specifics of my MRI scan, but I can tell you that I believe in this diagnostic tool. I know that in order to make such a statement there needs to be conclusive evidence to support it.

    I was scanned at an imaging center in Southern California on a GE 1.5-T Discovery MR with the center’s prostate protocol (with contrast) using an 8-channel cardiac coil (which provides adequate coverage of the area of interest). At this center they have what (I believe) is fairly new post-processing software that takes the pre- and post-contrast images and analyzes them to give either normal or “questionable” results.

    In my case they identified questionable areas in my prostate and recommended a biopsy. Let me point out that my PSA was and had been normal for the previous multiple years. I was asymptomatic, my DRE was normal, and I had no urinary, bladder, or sexual issues. My urologist went to the “questionable” locations when he performed the biopsy and found 3/12 cancerous samples.

    I had a (da Vinci robot-assisted) prostatectomy and am currently recovering. I hope this center eventually provides enough data and evidence so that MRI of the prostate becomes the tool to use before you go and get an invasive test (biopsy) where, as in one case personally known to me, during the biopsy, the colon was accidentally perforated and sepsis set in.

  3. Dear GratefulForMRI:

    I’m sorry but I have to ask …

    (a) If your PSA was “normal”, your DRE was “normal”, you were asymptomatic, and you had no urinary tract, bladder, or sexual issues, then why would anyone have recommended that you needed to have an MRI to see if you needed a biopsy (with or without MRI guidance)?

    (b) What were your Gleason scores on biopsy and on your pathological specimen post-surgery?

    If we are going to start doing MRIs on people just to identify “questionable” areas of the prostate, we will quite certainly be identifying the existence of low- and very low-risk prostate cancers in all sorts of people who don’t need to be treated at all (and who probably don’t need a biopsy either)!

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