If were such a thing as a Olympics for radical prostatectomy (RP), you might expect to see a gold medal awarded to a center like Johns Hopkins Brady Urological Institute, or one earned by Patrick Walsh. Such centers and individuals demonstrated a track record for excellence in this surgery. In fact, RP is the statistical yardstick or “gold standard” for PCa treatment success because the post-surgical specimens could be studied for biological and statistical data.
How to establish a treatment track record
There used to be only three PCa treatment options: RP, radiation, and watchful waiting. Today, there is a virtual smorgasbord of choices, allowing treatment to be matched with a patient’s disease. Historically, some of today’s valid treatments came into use without the more rigorous clinical trial standards expected today. However, clinical trials have become the preferred road to FDA approval.
Just as the Olympics are conducted under rules set by the International Olympics Committee (IOC), the proving ground for new therapies is overseen by the FDA. The FDA issues guidelines designed to protect participants. In addition, there are criteria for keeping records and analyzing data. Study sites and clinical investigators are vetted before they can conduct the research. Only high-caliber candidates need apply!
Gaining approval for MRgFUS
The Sperling Prostate Center is proud to have joined 7 other notable study sites for the clinical testing of MR-guided Focused Ultrasound (MRgFUS) as a focal alternative to RP. Once we achieved FDA oversight for our proposed trial, it was full steam ahead as all 8 sites collectively treated 101 enrolled patients (May 2017-Dec. 2018). At 24 months’ followup, targeted biopsy showed that 88% of men had no evidence of grade group 2 or 3 PCa in the treatment zone. In Dec. 2021, the FDA granted approval for MRgFUS treatment of prostate tissue.
If trophies were given to clinical trial sites that “win” FDA approval, our study’s display case would contain engraved cups for the following centers, in addition to our own:
- Memorial Sloan Kettering Cancer Center (New York, NY)
- Brigham and Women’s Hospital (Boston, MA)
- City of Hope Comprehensive Cancer Center (Duarte, CA)
- Mayo Clinic (Rochester, MN)
- UCLA (Lost Angeles, CA)
- Weill Cornell Medical College (New York, NY)
- Stanford University (Stanford, CA)
A closing note: Our study appeared in The Lancet, a publication “blue ribbon” in its own right. We congratulate all our fellow investigators and their fine cancer treatment centers on gaining FDA approval for a noninvasive focal therapy that will benefit thousands of PCa patients over the years to come.
If you or a loved one have been diagnosed with localized PCa and are interested in a focal treatment, the Sperling Prostate Center is a perfect starting point. We not only offer Exablate MRgFUS, we also provide Focal Laser Ablation and TULSA-PRO. Let us be your focal treatment expert for determining if you are a candidate, and matching your best focal method with your unique situation. Contact us for more information.
NOTE: This content is solely for purposes of information and does not substitute for diagnostic or medical advice. Talk to your doctor if you are experiencing pelvic pain, or have any other health concerns or questions of a personal medical nature.