The 4-year outcome of a study on Magnetic Resonance-guided Transurethral Ultrasound Ablation (TULSA) of the prostate reinforces the durable efficacy of the treatment, as well as the quality-of-life benefits for patients.
According to the data presented in Featured Abstract 9, “Pivotal Study of Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation (TULSA) of the Prostate: 4-year Follow-up,” MRI-guided TULSA remains safe and effective in patients with durable responses to 4 years in patients with low- to intermediate-risk prostate cancer (PCa). The abstract will be presented on Sunday, March 5, 3:45 p.m., Room 221AB of the Phoenix Convention Center.
“This abstract is a continuation of research we began over 4 years ago to explore the outcomes of a novel device that essentially heats prostate tissue noninvasively for cell death via coagulative necrosis,” said Steven Raman, MD, FSIR. “The 1-year data presented at SIR previously was very compelling, and the device was approved due to the strength of that data and is a golden opportunity for interventional radiologists to help treat PCa.”
According to Dr. Raman, the options for treating PCa have traditionally been suboptimal because the disease was suboptimally imaged with suboptimal imaging guidance and thermal monitoring. “We want to understand the disease, but until MRI, good imaging modalities were lacking. Based on our prior work, we can now confidently diagnose over 80% of intermediate and high risk PCa. Previously we used to diagnose PCa with template biopsy, which didn’t provide a good idea of the location and actual amount and grade of disease,” he said. While breast cancer was well imaged via a mammogram, there was no equivalent for prostate cancer.
“Using MRI and PSMA PET-MRI, we now can get a much better picture of where the intermediate and high risk PCa is in the prostate, as well as the size and staging with respect to lymph nodes. Now we can finally use MRI as well to also guide and monitor PCa treatment with therapeutic ultrasound in patients with intermediate risk prostate cancer,” he said.
When diagnosed with PCa, Dr. Raman says, patients are often given the decision on what type of treatment to pursue. Based on PSA, PSA density, MRI features, biopsy results and genomic analysis patients can choose to potentially undergo active surveillance in low-risk cancers, which includes watching the cancer with periodic imaging or biopsies. In patients with intermediate risk prostate who choose or require intervention may undergo traditional surgery or radiation therapy. However traditional therapies have a high rate of sexual and urinary side effects in the short and long term with up to a 30% risk of biochemical recurrence.
“Some patients are okay with that,” Dr. Raman said. “But some get very anxious and are looking for noninvasive alternatives.”
The MRI-guided TULSA device provides a new compelling outpatient option, offering a novel noninvasive mechanism with MRI guidance to treat either the whole or partial gland, with minimal sexual or urinary side effects up to 4 years based on this study.
As part of the multicenter trial to test efficacy, 115 patients received a single whole-gland TULSA treatment which spared the urethra and urinary sphincter. At 1 year, GG2 disease was eliminated in 79% of men, and 65% had no sign of disease. Median prostate volume decreased by 92%.
At 4 years, quality-of-life metrics held strong. Data showed that 75% of patients recovered erectile function at one year improving to 81% at four years. Urinary continence was achieved by 92% and 94% of patients at 1 and 4 years, respectively.
“The response to treatment was very good,” Dr. Raman said. “Essentially, over 80% had no cancer at a 1-year biopsy, and 20% had some low-grade cancer that were on surveillance. About 10% or less underwent other salvage treatments, but in the future that might be able to include repeat TULSA alongside traditional treatments.”
Dr. Raman describes these kinds of devices and techniques as disruptive, due to their ability to bring IR into the prostate cancer space.
“Prostate cancer is very common—there are almost 300,000 cases diagnosed annually, and very few IRs treating it,” he said. “IRs play crucial roles in the treatment of lung, kidney and liver cancer, and with these kinds of devices, IRs will now have an avenue to help men with prostate cancer undergo safe and effective treatment while minimizing sexual and urinary side effects.”
Additional trials to confirm the data are already underway, such as the CAPTAIN trial, which will randomize patients to either TULSA or traditional surgery. The trial is currently enrolling, and Dr. Raman plans to take part.
“There is a real opportunity for IRs to get involved in this space,” he said. “With these devices, we can use our specialized knowledge and imaging guidance and ablation skills to really change a patient’s quality of life.”
PLUS: Learn more about prostate cancer, TULSA and IR opportunities in the space on Wednesday, March 8 during “Advances in minimally invasive treatment of benign and malignant prostate cancer” at 8:30 a.m. in room 229AB.
