- Profound Medical Corp. (PRN) has treated the first patients in the level 1 trial of TULSA procedure to treat prostate cancer
- The level 1 CAPTAIN trial is a random controlled trial of 201 patients comparing the TULSA procedure with radical prostatectomy (RP)
- The trial is expected to take place at eight or more sites in the United States and two in Canada
- If the trial is successful, Profound will use data generated to drive broader awareness and adoption of TULSA-PRO
- Profound Medical Corp. (PRN)is down 4.09 per cent and is trading at $12.43 per share as of 2:20 p.m. EST
Profound Medical Corp. (PRN) has treated the first patients in the level 1 trial of TULSA to treat prostate cancer.
The level 1 CAPTAIN trial is a random controlled trial of 201 patients comparing the TULSA procedure with radical prostatectomy (RP) in men with intermediate-risk 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.
RP is currently the standard surgical treatment for intermediate-risk prostate cancer but carries risk of significant side effects such as long-term erectile dysfunction.
The TULSA procedure combines robotically driven therapeutic ultrasound with visualization of temperature via the urethra.
The high resolution of the target enables precise restoration of prostate tissue, 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.
The primary safety endpoint is the proportion of patients who preserve both erectile potency and urinary continence 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.
If the trial is successful, Profound will use data generated from CAPTAIN to drive broader awareness and adoption of TULSA-PRO.
Profound Medical Corp. (PRN)is down 4.09 per cent and is trading at $12.43 per share as of 2:20 p.m. EST.