PROCEPT BioRobotics Completes Enrollment in Key Prostate Cancer Study, Expands FDA Trial
Event summary
- PROCEPT BioRobotics completed enrollment in the WATER IV RP study comparing Aquablation therapy to radical prostatectomy, with 280 patients.
- FDA granted IDE approval for a second randomized study (WATER IV AS) comparing Aquablation to active surveillance in prostate cancer.
- WATER IV AS will enroll up to 333 patients globally and follow them for ten years, including biopsy and MRI assessments.
- Primary endpoint results from WATER IV RP are expected at the AUA Annual Meeting in spring 2027.
The big picture
PROCEPT BioRobotics is advancing its Aquablation therapy as a potential alternative to radical prostatectomy and active surveillance, addressing a significant unmet need in prostate cancer treatment. The completion of the WATER IV RP study and the expansion into WATER IV AS position the company to challenge existing standards of care, particularly in preserving quality of life for patients. The rigorous, long-term design of these studies sets a new benchmark for evaluating prostate cancer therapies early in their development.
What we're watching
- Clinical Efficacy
- Whether Aquablation therapy can demonstrate superior disease control and quality-of-life outcomes compared to radical prostatectomy and active surveillance.
- Regulatory Pathway
- The pace at which FDA approvals may accelerate based on WATER IV study results, potentially expanding market access.
- Competitive Positioning
- How PROCEPT BioRobotics will leverage long-term data to differentiate Aquablation in the prostate cancer treatment landscape.
Related topics