- Profound Medical's (PROF, Financial) CAPTAIN trial shows TULSA's superior perioperative outcomes over robotic radical prostatectomy.
- TULSA patients reported zero blood loss, shorter hospital stays, and significantly less post-operative pain.
- The trial marks a significant milestone with 201 patients randomized across 23 sites.
Profound Medical Corp. (PROF) has announced promising results from its CAPTAIN trial, demonstrating that the MRI-guided TULSA procedure offers a statistically significant improvement in postoperative experience compared to robotic radical prostatectomy (RP) for prostate cancer treatment. The Level 1 study, which is the first of its kind to compare TULSA head-to-head with RP, involved 201 randomized patients across 23 sites.
Key findings from the trial indicate that TULSA patients experienced zero blood loss, a stark contrast to the 100-200 mL typically observed with RP. Hospital stays were also significantly reduced, with TULSA patients requiring an average of just 0.29 days compared to 1.24 days for RP patients. Additionally, TULSA patients reported much lower post-operative pain levels through day 6 and displayed higher overall health scores for 30 days post-treatment.
The trial's results also highlighted better outcomes for TULSA patients in terms of mobility, self-care, and usual activities. Notably, 0% of TULSA patients reported extreme problems with mobility compared to 12% of RP patients. Similarly, only 3% of TULSA patients had issues with self-care versus 17% for RP, and 17% experienced difficulties with usual activities compared to 40% in the RP group. The balanced patient characteristics, including a median age of 63 years and similar PSA levels, lend credibility to the study's findings.
These impressive perioperative results suggest that TULSA could become a superior alternative to traditional prostate cancer surgeries, potentially transforming treatment standards and improving patient outcomes. As the trial continues to gather long-term data, Profound Medical anticipates that these findings will encourage wider adoption of the TULSA technology and support its case for insurance coverage.
