The prospective, multi-center randomized controlled trial of 201 patients is designed to compare the safety and efficacy of the TULSA procedure with RP in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer.
In the CAPTAIN trial, 134 patients will be randomized to receive one or two TULSA procedures and 67 patients will be randomized to receive RP. The trial is expected to take place at eight or more sites in the United States and two in Canada. Of those, six sites have been activated to date and are currently recruiting patients.
RP is currently the gold-standard surgical treatment for intermediate-risk prostate cancer. RP effectively controls disease but carries risk of significant side effects, such as long-term erectile dysfunction and urinary incontinence.
The TULSA procedure combines transurethral, robotically-driven therapeutic ultrasound with real-time visualization of temperature and automated control of heating from magnetic resonance thermometry. The high spatial, thermal, and anatomic resolution of the target volume enables precise ablation of prostate tissue while sparing functionally important structures, potentially reducing the risk of side effects relative to RP.
The goal of CAPTAIN is to demonstrate that the efficacy of the TULSA procedure is not inferior to RP, while demonstrating superior quality of life outcomes.
“CAPTAIN is a post-market study intended to support coverage by payers,” Arun Menawat, Profound’s CEO and chairman, said in a statement.
“Notably, this will be the first Level 1 study ever conducted comparing an emerging technology head-to-head with RP in men with prostate cancer. So, if successful, in addition to helping advance our reimbursement strategy, we believe the data generated from CAPTAIN has the potential to drive much broader awareness and adoption of TULSA-PRO,” he added.
The primary safety endpoint is the proportion of patients who preserve both erectile potency and urinary continence at one year after treatment. The primary efficacy endpoint is the proportion of patients who are free from any additional treatment for prostate cancer by three years after treatment. Secondary endpoints include comparison of rates of complications, cost effectiveness, and timing of the return to baseline activity. Long-term follow-up will be gathered for up to 10 years after treatment.