Higher Radiotherapy Doses But Fewer Treatment Sessions May Be Possible, Early Trial Data Suggest

Higher Radiotherapy Doses But Fewer Treatment Sessions May Be Possible, Early Trial Data Suggest
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clinical trial recruiting

Prostate cancer patients may benefit from a new form of radiation therapy that delivers larger doses per session but in a much shorter treatment course, and when used in combination with a hydrogel spacer that helps to protect the rectum, early results from the ongoing SPORT trial suggest.

Stereotactic Ablative Body Radiotherapy or SABR uses small, thin beams of radiation that are directed into the tumor from different angles. The treatment targets the tumor, which receives a high dose of radiation, while avoiding healthy tissues nearby.

SABR allows for dose escalation, which conventional radiotherapy cannot, and patients can finish a full course of radiotherapy in five hospital visits instead of the standard 37.

The SPORT trial (NCT03253978), which is now enrolling in Belfast, Ireland, is looking at the effects of SABR in patients with prostate cancer. The study, sponsored by the Belfast Health and Social Care Trust, aims to recruit 30 patients who will be given five doses of SABR.

Before starting treatment, participants will also receive a minimally invasive hydrogel – called SpaceOAR hydrogel – which acts to create space between the rectum and the prostate, making it less likely that the rectum is exposed to radiation.

According to Augmenix, its hydrogel makes it possible to use higher doses of radiation without affecting the rectum and surrounding tissues, leading to fewer complications.

The company also reports that studies in the U.S. and Europe showed patients who received the SpaceOAR hydrogel had less rectal pain, as well as fewer bowel (66%), urinary (65%) and sexual complications (78%) than patients who served as a control group and were not given the hydrogel. The U.S. Food and Drug Administration (FDA) approved its use for prostate cancer patients undergoing radiotherapy in 2015.

“One of the complications from using radiotherapy is the potential damage that can be inflicted on neighbouring tissues,” Ciaran Fairmichael, clinical research fellow at Queen’s University Belfast and one of the trial’s lead researchers, said in a press release.

Results from the study’s first six patients showed that the hydrogel’s use resulted in a clinically and statistically significant reduction in radiation affecting the rectum.

These findings were published in the British Journal of Radiology in the study “Efficacy of a rectal spacer with prostate SABR—first UK experience.”

“If it wasn’t for this research, I simply would not be here,” Gordon Robinson, 70, a trial participant, said in the release. “Taking part in this trial meant I was offered a high-dose five treatment course instead of enduring two months of treatment. The treatment was really successful in getting rid of my tumour. I knew about the side effects of treatment, and they really frightened me, but this trial meant I had very little discomfort or complications and can return to normal life.”

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