The Advanced Prostate Care Center at WellSpan York Hospital offers men a multitude of treatment options, including treatment without radiation, incisions or long recovery times. TULSA-Pro®, Transurethral Ultrasound Ablation of the Prostate, is a minimally invasive procedure that combines real-time imaging using MRI technology with directional ultrasound to produce temperatures high enough to ablate targeted cancerous tissue in the prostate.
Profound Medical Corporation, based in suburban Toronto, introduced TULSA in Canada in 2015. The procedure was FDA cleared in 2019, and first performed at WellSpan in 2022.
“We just completed TULSA on patients 50 and 51 last week,” stated Dr. Edward Steiner on April 29, 2024. Steiner is an interventional radiologist and director of the Advanced Prostate Care Center at WellSpan York Hospital. Nationally, at least 1,600 men have received the TULSA treatment.
Edward Steiner, MD, FACR
WellSpan is the eighth site in the United States to acquire the technology and one of only 23 sites nationally to perform the procedure. Others include Yale New Haven Hospital, Johns Hopkins Hospital and Stanford Medical Center.
The Advanced Prostate Care Center treats prostate patients from Maryland, western Pennsylvania, New Jersey and upstate New York in addition to the York region. “The population of South Central Pennsylvania is underserved,” Steiner said, “and we provide much needed services to men in the area.”
Until recently, few options existed for men diagnosed with prostate cancer. If radiation did not shrink the tumor, prostatectomy, or even death from cancer, was the ultimate outcome.
But Tulsa changes all that, according to Dr. Adnaan Moin, an interventional radiologist who works alongside Steiner and the other members of the prostate care team, which includes a nurse practitioner, MRI technicians, a nurse anesthetist and an anesthesiologist.
“The biggest benefit of this procedure is that we can do localized treatment,” Moin said. “You can do half a gland, you are able to protect nerve bundles and you minimize traditional side effects.”
Adnaan S Moin, MD
What is TULSA-Pro?
After sedation, the patient is placed inside the MRI so the physician and team can use the technology to guide and place two catheters, one in the urethra and one in the rectum. The rectal catheter cools the area of focus while the urethral catheter destroys the tumor by heating it to nearboiling.
“Device placement isn't extremely challenging,” Moin said. “It's similar to placing a foley catheter; it's just a stiffer device. The system provides guidance to make sure the device is in the right location, to make sure you are ablating within the margins,” said Moin.
The technology constantly monitors the patient during the ablation. “Every few seconds there is a feedback loop precisely defining the prostate temperature with the MRI,” said Steiner. “We monitor the procedure literally every minute during the one- to two-hour ablation. This is what makes this procedure safe. It's customizable, we can avoid the nerve bundle and stay within the tumor's margins.”
The ultimate success of the procedure comes down to selecting the appropriate patients. Age is not a limitation, though prostate size can be. “We routinely operate on 75-year olds,” said Steiner, “and we have done patients as young as 52.”
As for size of the gland, “it has to be less than six centimeters in diameter, three centimeters from the urethra on all sides,” Steiner noted. “The smaller the gland, the easier the ablation. A patient cannot have calcification or metal in the prostate or the ultrasound becomes ineffective.”
Before a patient can be considered for TULSA, the team examines several factors. “Every patient has to have a prostate biopsy and an MRI prior to us fully evaluating them,” said Moin. The team performs hundreds of biopsies a year, which increases the amount of cancer that is found.
TULSA is intended mostly for men with low- and intermediate-risk prostate cancer that hasn’t spread. When considering treatments for prostate cancers, Steiner quickly realized the advantages of the procedure. “This procedure is novel, FDA approved with fewer complications,” said Steiner.
"TULSA may be attractive to some younger men since it is associated with low rates of sexual dysfunction and urinary leakage," noted Steiner. With TULSA, zero percent have urinary leakage and only two percent experience erectile dysfunction.
Not only that, TULSA allows patients to return home after four hours, with few exceptions requiring an overnight hospital stay. That means Steiner and his team perform two ablations a day. “Timing is the real advantage to Tulsa,” said Steiner. “Most patients do just fine with a few days away from work. You can't do heavy lifting, but those with a sedentary job can return to work if they feel like it.”
Moin trained at the same time as Steiner. “We are unique here at WellSpan in that urological radiologists are providing backup, but we're the primary operator for both the device placement and the procedure using the MRI,” said Moin. “At other sites, it's a split venture— the urologists do the placement while the radiologists will monitor the MRI during the procedure.
Moin continued, “We work hand-in-hand with urologists as far as patient follow-up and patient monitoring.” Side-effects of TULSA remain similar to traditional prostatectomy with one benefit. “The potential side effects are the same,” Steiner noted, “but their incidence is significantly lower. In the latest clinical trials, urinary competency is maintained by 98 percent of men, there is low rectal injury, and erectile function is maintained in 98 percent of patients. Patients will return to the same level as before the ablation in three to six months; the results are not immediate.”
There often is swelling in the pelvis, but most patients feel no pain; if they do feel pain, analgesics take care of the problem. Bleeding does occur in some patients. It generally stops the next day, and any blood in the urine clears up within days. “The entire procedure is less traumatic to the patient than a biopsy,” Steiner said.
Patients spend approximately four hours in the surgery center, three hours of ablation time and one hour of recovery. “Patients go home with a foley catheter that stays in place for two weeks,” said Steiner. “We do a follow-up, which includes a urination test. We fill the bladder with 40 ccs of normal saline and see if the patient can urinate. If they can't, we put the foley back in for another few days.”
For decades, hormone therapy, including brachytherapy, the implantation of radioactive seeds into the prostate gland, guided the treatment of prostate cancer. Radiation is still used to destroy cancerous tissue. TULSA adds another element to our arsenal to offer patients individualized treatment.
Historically, men sometimes hesitate to seek medical care, but the minimally invasive nature of TULSA could help change minds. “Men don't take care of themselves to the same level as women” said Steiner. And even though a man doesn't need a prostate unless he is actively trying to have children, it's still important to practice prevention, especially monitoring PSA levels and receiving digital exams by a medical provider.
Normal PSA levels, diagnosed through bloodwork, are up to 3 for ages 50 to 59, up to 4 for ages 60 to 69, and up to 5 for ages 70 to 79. An elevated PSA doesn't necessarily mean a tumor exists, but it is cause for further monitoring and testing. At WellSpan, Steiner and his team conduct “fusion biopsy” to more exactly excise prostate tissue so it can be further tested.
“When a patient has an elevated PSA and there is suspicion of cancer, we conduct an MRI to confirm cancer and the location of the lesion,” Steiner said. “We take those MRI images, convert them into a three-dimensional model and take that information into the operating room. “From there we fuse the data from the MRI with the live image of the patient and using GPS technology we biopsy the lesion very accurately. Those results generally will be approximately 30 percent more accurate than a blind biopsy.
“After we receive the results, the tumor is categorized and classified to tell us how aggressive the tumor is, and if it is cancer. Then, using that same information, TULSA is performed based on the MRI and pathology findings.”
Steiner made sure this fusion biopsy could be brought to WellSpan to further enhance prostate treatment. “We brought this technology to York to better diagnose prostate cancer.”
These diagnostics are important because prostate cancer is the second-most common cancer and the second-most fatal cancer in American men, according to the American Cancer Society. The chance of developing prostate cancer increases as a man ages, and most prostate cancers are found in men over the age of 65.
TULSA changes the treatment dynamic with its less invasive treatment and tolerable recovery. Recurrence of prostate cancer is between 10 percent and 20 percent, no different with TULSA than with prostatectomy.
“If, two to three years after TULSA we notice the PSA rising again, we can repeat the treatment,” Steiner said. “You can take care of the problem and that is very attractive to patients.”