510(k) clearance pending for novel patient positioning system for radiation therapy

A patient positioning system capable of providing radiation therapy to patients with cancer, including those with prostate cancer, in an upright, seated position is pending 510(k) regulatory clearance by the FDA, announced Leo Cancer Care, the developer of the technology, in a news release.¹

Data on the delivery of radiation therapy in an upright position was published earlier this year.

"This is a highly significant milestone for our company; 510(k) submission is an important step forward in our drive to see cancer therapy delivered to patients in a more human way,” commented the CEO of Leo Cancer Care, Stephen Towe, in the news release.¹

According to Leo Cancer Care, the system may improve patient experience, comfort, and access; boost clinical effectiveness; and provide a more cost-effective way to deliver radiation therapy for cancer.

Data on the delivery of radiation therapy in an upright position was published earlier this year.^2,3 The investigators observed thatthe upright position may hold benefits over treatment delivered in the supine position due to anatomical changes in the male pelvis.

In total, the study included 15 patients between 55 and 75 years of age. Each participant underwent an MRI scan in the supine position and in the upright position with a full and voided bladder in order to observe anatomical changes in the pelvis.

The investigators noted 5 key findings from imaging done in the upright position compared with the supine position:

1. Position and shape of the prostate are not impacted significantly by bladder fill.
2. Distance between the sacrum and the anterior bladder wall is significantly smaller.
3. Anterior-Posterior length [of the bladder] and bladder width is significantly larger.
4. Seminal vesicles are pushed down by the bladder.
5. Top of the penile bulb is further away from the apex of the prostate.²

Based on those findings, the authors suggested that upright positioning for radiation therapy may hold benefit over the supine position by:

1. Reducing the risk of small bowel approximating the treatment volume.
2. Prostate treatments can be done with a reduced focus on bladder fill.
3. Radiation beams for treating intermediate risk prostrate can be made smaller or a larger portion of the seminal vesicles can be treated with the same beam size than typically used for supine treatments.
4. Reducing the average dose to the penile bulb.²

Chief Scientific Officer of Leo Cancer Care Niek Schreuder commented in a news release on the findings,³ "The study revealed that the anatomical changes in the male pelvis could potentially favor the upright position for prostate treatments. The increased downward pressure from the abdominal contents on the bladder and prostate in the upright position appears to have a stabilization effect on the prostate [because] the changes in bladder fill did not [affect] the prostate position and orientation in the same manner as reported in the literature for the supine position. This holds great promise for upright prostate treatments removing the burden of reproducing the bladder volume at the time of the CT scan.”

510(k) clearance by the FDA would grant commercial availability of the upright positioning system to US-based urologists treating patients with prostate cancer.

References

1. Pending 510(k) decision for Leo Cancer Care paves the way for new era of patient cancer care. News release. Leo Cancer Care. Published online and accessed September 29, 2023. https://www.prnewswire.com/news-releases/pending-510k-decision-for-leo-cancer-care-paves-the-way-for-new-era-of-patient-cancer-care-301942991.html

2. Schreuder A, Hsi WC, Greenhalgh J, et al. Anatomical changes in the male pelvis between the supine and upright positions—A feasibility study for prostate treatments in the upright position. J Appl Clin Med Phys. Published online July 24, 2023. Accessed September 29, 2023. doi:10.1002/acm2.14099

3. Study conducted by Leo Cancer Care indicates treating prostate patients with radiation therapy in the upright position shows “promise.” News release. Leo Cancer Care. August 3, 2023. Accessed September 29, 2023. https://www.prnewswire.com/news-releases/study-conducted-by-leo-cancer-care-indicates-treating-prostate-patients-with-radiation-therapy-in-the-upright-position-shows-promise-301892702.html