The Sperling Prostate Center is pleased to join seven academic centers in announcing the results of our national clinical trial of a novel focal prostate cancer (PCa) treatment. The multicenter study number NCT01657942 is titled Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions. Study sites also included Weill Cornell University, Stanford University, UCLA, City of Hope, The Mayo Clinic, Memorial Sloan Kettering Cancer Center, and Brigham & Women’s Hospital/Harvard University.
Our results were presented as an abstract (summary) during the American Urological Association’s annual meeting which was held September 10-13, 2021 in an online virtual assembly. It gives us great pleasure to share our great results with you, literally hot off the presses.
The study was designed to treat focal PCa lesions using MRI-guided Focused Ultrasound (MRgFUS). Basically, it is a HIFU (high intensity focused ultrasound) treatment, but rather than using the guidance of visual ultrasound, which does not distinguish tumor from healthy tissue, MRgFUS is the noninvasive delivery of targeted beams of ultrasound under visual MRI guidance. To assure accurate tumor destruction, temperature in the treatment zone is monitored by real-time MR thermometry.
Our study began enrolling patients in October, 2013, and each patient was evaluated, diagnosed, treated and then followed for two years. Our objective was twofold:
- Evaluate treatment safety – incidence and severity of adverse events, and risk of incontinence and impotence associated with MRgFUS focal treatment of intermediate risk organ confined prostate lesions, and
- Evaluate treatment effectiveness in the zone of ablation as confirmed by MRI and MRI-targeted biopsy.
The single arm trial involved 101 patients with a confirmed PCa diagnosis (imaging and combined targeted/systematic biopsy) of Grade group 2 or 3 focal lesion. All lesions were treated focally with an additional margin of normal tissue (> 5mm). Prior to treatment, baseline urinary and erectile function were assessed by quality of life (QOL) questionnaires and recorded.
The study protocol for each patient included: a) diagnostic biopsy; b) MRgFUS focal treatment; c) PSA, exam, QOL questionnaires every 3-6 months; d) mpMRI and MRI targeted/systematic biopsy at 6 months; and e) repeat imaging and targeted/systematic biopsy at 24 months.
Findings and results
Here are the important findings, in terms of the twofold objective:
- No serious adverse events were observed. The majority of minor/moderate events (e.g., bowel disruption, fatigue, urinary tract infection, blood in urine or sperm, ejaculation disorder) occurred in anywhere from 1-13 men and cleared up on their own. Furthermore, in terms of risks to urinary and sexual function, at 24 months urinary scores were similar to baseline; and at 24 months, 81% of participants achieved erections adequate for intercourse, while 13% reported no sexual activity.
- At the 24-month biopsy, 88% of men had no evidence of Grade group > 2 PCa in the treatment area. Furthermore, 60% of men had no evidence of Grade group > 2 PCa anywhere in the gland, including PCa detected outside the treatment area.
As a result, our study concluded that MRgFUS focal therapy using real-time MR thermometry is safe and effective for Grade groups 2 and 3 PCa, based on 24-month biopsy outcomes.
Great news for prostate cancer patients
What’s the great news? Patient-reported sexual function and urinary continence after MRgFUS focal therapy is superior, compared with data from both radical prostatectomy and whole-gland beam radiation. The two-year cancer control rate is comparable. In short, MRgFUS offers intermediate risk patients a way to avoid or defer whole-gland treatment while preserving urinary and sexual function.
At the Sperling Prostate Center, we are honored and grateful to have participated in this study. Our experience and state-of-the-art MRgFUS system place us on a par with large, authoritative institutions, something we are justly proud of. Most importantly, we’re all in this together as we research and test advantageous, effective treatments. Our shared goal is the preservation of men’s lives along with the highest possible quality of life as we seek to vanquish prostate cancer once and for all.
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.