TORONTO – October 14, 2026 -- Patients treated with whole-gland TULSA were more than twice as likely to preserve both erectile function and pad-free continence at six months as those who had robotic radical prostatectomy (risk ratio 2.1; p=0.004), according to CAPTAIN trial data. Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) presented the results among five abstracts at the 15th Interventional MRI Symposium in Boston.
CAPTAIN trial shows whole-gland TULSA cut complication hospitalizations to 0.7% versus 6.3% for robotic surgery
CAPTAIN is the first fully enrolled, multicenter randomized controlled trial to compare the TULSA Procedure directly with robotic radical prostatectomy in localized intermediate-risk prostate cancer. Whole-gland TULSA also showed statistically superior preservation of flaccid penile length at one month.
Previously reported perioperative data showed no blood loss, no overnight hospitalization, faster recovery and earlier return to work with TULSA. Oncologic outcomes are still maturing.
Mayo Clinic Florida reports 100% pad-free continence in 58 patients followed for up to 4.5 years
The analysis covers one of the early U.S. centers to use TULSA-PRO in routine practice. Treatments ranged from focal and hemi-gland to subtotal and whole-gland ablation. No strictures or fistulas were reported.
Beyond 12 months, 94% of patients were leak-free and 87.5% kept erections sufficient for penetration. Median PSA nadir was 0.9 ng/mL, and 12% of patients needed secondary prostate cancer treatment. Profound noted the single-center design, patient selection and treatment heterogeneity as limits on interpretation.
Mayo Clinic Rochester study records 22% biopsy-confirmed recurrence among 41 patients
The prospective study enrolled patients with biopsy-proven localized prostate cancer. Mean PSA fell from 7.7 ng/mL at baseline to about 2.3-2.6 ng/mL, a sustained reduction of roughly 62%-66% through one year.
Of the recurrences, 12% were in-field and 10% out-of-field. Most adverse events involved urinary or sexual function. The authors concluded that TULSA delivered substantial, sustained PSA reduction with a generally favorable safety profile. Continued follow-up is needed to establish oncologic durability.
CARE Registry links broader ablation to lower PSA nadirs but longer catheterization
The registry analysis covered 197 patients at five centers, with median follow-up of 24 months. Median PSA nadir was 0.23 ng/mL after whole-gland treatment, 0.60 ng/mL after subtotal and 1.10 ng/mL after focal treatment.
Biochemical recurrence rates did not differ significantly across treatment extents. Median catheterization fell from 13.5 days after whole-gland treatment to seven days after subtotal or focal treatment.
Siemens 0.55T Free.Max validation improves thermometry precision by 40%
Investigators validated the technical feasibility of TULSA on Siemens' lower-field-strength 0.55T Free.Max platform. New three-dimensional thermometry protocols improved temperature-measurement precision by 40% over conventional approaches. Baseline uncertainty was about ±1.1°C, approaching conventional 1.5T systems. Simulated treatments showed targeting accuracy of 1.0 ± 0.9 mm.
Profound says compatibility with lower-cost, wide-bore MRI systems could reduce equipment-related infrastructure barriers, widen the potential TULSA-PRO installed base and mitigate susceptibility artifacts from implants such as hip prostheses. The company stressed that technical feasibility does not establish U.S. FDA clearance, clinical validation or commercial availability on the combined TULSA-PRO and Siemens 0.55T Free.Max platform.
Chief Executive Arun Menawat said the evidence reinforces TULSA's potential of "becoming a mainstream treatment modality across the entire prostate disease spectrum."