New Studies to Watch For

By: Dan Sperling, MD

Many focal laser ablation patients, and those considering this targeted prostate cancer treatment, are eagerly anticipating the May 15-19 American Urological Association meeting in New Orleans. Given that the majority of urologists are not exactly FLA-friendly, why would fans of our pioneering and elegant therapy set their sights on this meeting? Some members of the Focal Laser Ablation Patients discussion board at inspire.com are anticipating that Dr. Peter Pinto of the NIH/NCI Urologic Oncology Branch will announce results of an ongoing clinical trial of MRI-guided FLA. I was not able to confirm this, but until an official announcement, data from clinical trials is confidential and well-guarded. Patients crave such information for three reasons:

  1. Good results boost patient confidence, especially in response to naysayers.
  2. Patients who mount an insurance appeal after being denied coverage are eager for peer-reviewed evidence that the denial is poorly informed.
  3. Published mid- to long-term results are a step toward Medicare reimbursement, and even though this process requires great patience, it won’t happen without demonstrated durable safety and effectiveness.

As soon as I know whether the rumor is true, and exactly what Dr. Pinto announced, I will relay it here because the AUA is just around the corner, and I’ll be just as eager as the patient community to learn the results!

Another study that’s worth waiting for—though it will be a much longer time in coming—was just announced by a group of top-drawer British researchers.[i] The study, called PROMIS (Prostate MR Imaging Study) is to evaluate how well pre-biopsy multiparametric MRI (mpMRI) improves the detection of clinically significant prostate cancer (PCa). “Significance” is defined as Gleason grade >4+3 and/or maximum PCa biopsy core length of ?6mm. This is an important study because standard TRUS biopsies can undergrade prostate cancer or miss it altogether. In addition, the design of the study is excellent.

It will involve a paired cohort of men at risk of prostate cancer before a first biopsy (up to 714 men). In order to investigate whether mpMRI can discriminate between men with and without clinically significant PCa, the imaging results will be compared with 10-12 core TRUS biopsies as the standard, and with transperineal template mapping biopsies (samples take 5 mm apart throughout the gland) as the pathology reference. The conduct and reporting of each test will be blinded to the others.

The results (sensitivity, specificity, positive and negative predictive values) of both mpMRI and TRUS will be compared against the transperineal biopsies. Specifically, the mpMRI results will be assessed to determine how well they were able to predict those who could safely avoid biopsy without “compromising detection of clinically-significant cancers.” The study will also produce other secondary outcomes, including cost effectiveness of mpMRI.

I hope you will look forward to each of these study reports as much as I do.

 


 

[i] El-Shater Bosaily A, Parker C, Brown LC et al. PROMIS – Prostate MR imaging study: A paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer. Contemp Clin Trials. 2015 Mar 3;42:26-40. doi: 10.1016/j.cct.2015.02.008. [Epub ahead of print]

 

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