On July 13, the first transurethral localized sonographic ablation (TULSA) procedure was performed at Yale New Haven Hospital. Preston Sprenkle, MD, associate professor of urology; Raj Ayyagari, MD, associate professor of radiology & biomedical imaging; and Sandeep Arora, MBBS, assistant professor of radiology & biomedical imaging, collaborated to perform the procedure.
TULSA is a minimally-invasive procedure, performed with the patient under anesthesia, to treat localized prostate cancer while protecting tissue surrounding the prostate. Dr. Arora explains, "TULSA uses heat generated by a high intensity ultrasound to kill cancer cells. MRI guidance and MR thermometry are used during the TULSA procedure to achieve conformal treatment zones and to ensure that any structure outside the treatment contour does not receive the lethal thermal dose."
Being able to offer TULSA provides another treatment option for patients with unique circumstances. For instance, patients who have had previous rectal surgery and/or radiation to the pelvis and are unable to undergo more radiation, or if another surgery would have been very difficult or dangerous, TULSA can be an appropriate option. Almost all other ablation technologies require transrectal ultrasound guidance, so TULSA is unique in that it ablates prostate tissue through the urethra.
Multiple studies have also shown this technology to have excellent efficacy in treating lower-grade prostate cancers because of its whole-gland approach, while maintaining a superior risk profile because of the treatment area precision that MRI guidance provides. Furthermore, patients who are also suffering from co-existing bladder outlet obstruction caused by benign prostatic hyperplasia (BPH) often also experience significant improvement of those symptoms.
"We are very excited to kick off the TULSA program," said Dr. Sprenkle. "It has a great deal of potential to provide treatment for prostate cancer while limiting some of the more toxic side effects such as erectile dysfunction, urinary incontinence, and rectal toxicity/problems."
"We have now performed our first two procedures with great success, and have thereby made Yale one of a handful of medical centers in the country to offer this clinical service, and the first medical center in the country to offer such this treatment through clinical trials as well. With this new service, we hope to continue elevating Yale’s reputation as national center of excellence for the treatment of prostate cancer,” said Dr. Ayyagari.
TULSA Clinical Trial Now Available
As noted, the TULSA clinical trial for men with localized prostate cancer is now available at Yale Cancer Center. "Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study" is to designed further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.