According to the American Cancer Society, approximately one in eight deaths worldwide is due to cancer, and approximately 12 million new cases of cancer are diagnosed globally each year. It is estimated that the incidence of cancer will rise in the coming years as a result of increased life expectancy, aging populations, and technological improvements leading to more sophisticated screening techniques and earlier cancer detection.
The three primary methods of treating cancer are radiation therapy, chemotherapy and surgery, each of which can be used alone or in combination, depending on the type of cancer being treated. Radiation therapy is a proven, effective and widely accepted form of treatment for many types of cancer. The National Cancer Institute estimates that nearly 50% of cancer patients in the United States are treated using radiation therapy.
Currently, the most common type of radiation therapy is external beam radiation therapy, or EBRT, in which patients are treated with high-energy radiation generated by medical equipment external to the patient. Another form of radiation therapy is brachytherapy, in which clinicians insert tiny radioactive pellets into a cluster of cancer cells, or tumors, in order to gradually dissolve and destroy cancer cells internally.
Market Need
The prostate gland wraps around the urethra and is located below the bladder and in front of the rectum. 
The adjacent images show undesired radiation exposure on the rectum during radiation therapy. The goal of all radiation therapy is to maximize the radiation hitting the prostate and to minimize its impact on surrounding tissue.
However – due to the close proximity of the prostate to surrounding tissue – radiation therapy can expose healthy tissue outside the intended treatment area to significant doses of radiation.
Since the prostate and the rectum are only separated by a distance of 3 to 10 mm, radiation therapy can inadvertently cause rectal toxicity in 10-20% of cases.
The morbidity associated with radiation therapy can affect not only patients’ quality of life, but also result in health conditions that may require significant interventions.
Rectal toxicity causes soreness, diarrhea, perforation, and severe bleeding or bloody discharge. Furthermore, radiation therapy can increase the risk of rectal cancer by as much as 70%.
- GRADE 2
- GRADE 3
- GRADE 4
Acute GI toxicity
- Diarrhea requiring medications, rectal pain requiring analgesics
- Diarrhea requiring parental support, severe mucous or bloody discharge requiring pads, abdominal distension
- Obstruction, fistula or perforation abdominal pain or tenesmus requiring decompression or diversion
Late GI toxocity
- Moderate diarrhea; intermittent, severe cramping; frequent bowel movements (above 5 per day); frequent bleeding
- Watery diarrhea, obstruction requiring surgery, bleeding requiring surgery or 2 and above cauteries and/or transfusions
- Necrosis, perforation, abdominal pain, or tenesmus requiring decompression or diversion
