First Patient Enrolled in ARID II Trial for Prostate Cancer Treatment

The first patient has been enrolled in the ARID II trial for prostate cancer: stock.adobe.com.

The first patient has been enrolled in the pivotal ARID II trial, which is designed to investigate the safety and effectiveness of Voro Urologic Scaffold in adult men with prostate cancer undergoing robotic assisted radical prostatectomy, as compared with control, according to a news release from Leevee Medical.

The Voro Urologic Scaffold is designed to ease pressure on the urinary sphincter by extending the effective urethra after robot-assisted radical prostatectomy, according to a study published in Urologia Internationalis. It is placed at the anastomotic site, covering the bladder neck and urethral stump after the prostate is removed and before the anastomosis is created.

Mississippi Baptist Medical Center was the first site to enroll a patient onto the ARID II study, led by Dr. Patrick Daily.

"What is truly exciting is the potential for this device to meaningfully improve early and long-term continence rates, which can profoundly impact a patient's recovery and overall quality of life,” said Daily in the news release. “We're excited to be the first site to enroll in the study and I look forward to seeing the outcomes once the study is complete.”

Daily is a board-certified urologic surgeon at Mississippi Urology Clinic. He is also a member of the American Urological Association, Endourological Society, Mississippi State Medical Association and Central Mississippi Medical Society.

"Initiating the ARID II trial marks an important step as we build upon the promising results of our initial feasibility study," Bruce Choi, founder, director, CTO and chairman of Levee Medical, said in the news release. "This next phase brings us closer to providing a new standard of care for men recovering from prostate cancer surgery."

The ARID II study has launched following positive results from the phase 2 ARID feasibility study, which enrolled 28 patients, the company announced in a previous news release.

“Our experience with the Voro Urologic Scaffold has been extremely encouraging,” said principal investigator Dr. Gustavo Espino of Hospital Nacional in Panama City in the news release. “The device had an outstanding safety profile, and patients have noted early improvements in continence, which translates to a considerably better quality of life post-surgery.”

The prospective feasibility study aims to enroll 40 adult patients across three clinical trial sites in Panama. Eligible participants must be 45 to 70 years old, have Gleason grade group 3 or lower prostate cancer, and a prostate size under 80 grams.

The trial’s primary endpoint is change in pad weight on a 24-hour pad weight test from baseline to 6 and 12 months after radical prostatectomy. Secondary measures include change in the standing cough test over a specific period.

Study completion is expected in October 2026.

The device is also being evaluated in the observational ALTO study, which began enrolling patients in June 2024. That study is tracking urinary function and quality of life in patients post-radical prostatectomy, with completion expected in March 2026.

Prostate cancer forms in the prostate, a gland below the bladder in the male reproductive system, and usually affects older men, according to the National Cancer Institute. Treatment may involve a prostatectomy, the surgical removal of part or all of the prostate, nearby tissue and sometimes lymph nodes. This can be done through open surgery, laparoscopy or robotic assistance, with care taken to protect nerves that control bladder function and erections whenever possible.

Reference:

“Initial Experience with an Absorbable Urologic Scaffold to Mitigate Early Urinary Incontinence following Radical Prostatectomy: A Report of 2 Cases,” by Dr. Michael N. Ferrandino, et al., Urologia Internationalis.

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