Topline results seem to give support to Blue Earth Diagnostics’ test to help impact treatment decisions for patients. The Burlington, MA-based company presented results from the LOCATE investigational trial at the American Urology Association’s annual meeting.

LOCATE is a prospective, multi-center, open label study conducted at 15 sites in the U.S. The study’s primary endpoint measured the percentage of men with suspected biochemical recurrence of prostate cancer following initial prior therapy whose treatment plan was changed following Blue Earth Diagnostics’ 18F fluciclovine PET/CT scan.

The diagnostic was approved by the FDA in 2016. The molecular imaging agent is for use in PET imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate specific antigen following prior treatment.

Blue Earth Diagnostics’ CEO Jonathan Allis, told MD+DI that it wasn’t enough to merely have FDA approval for the diagnostic and that the company had to prove if the test could make a difference.

“We asked ourselves how does this diagnostic change [patient] management,” Allis said. “We did the [LOCATE study] to try and understand that. The studies worked out very well and it does show this agent has the potential to change patient management.”

Of the 128 patients whose original treatment plan was salvage radiation therapy (with or without androgen deprivation therapy, or ADT), 51% (65/128) had their treatment changed after 18F fluciclovine PET/CT. Of the 60 patients originally planned to be treated with ADT, 45/60 (75%) had their treatment changed to a non-systemic salvage treatment after 18F fluciclovine PET/CT, with 30 of these changes to a non-systemic salvage treatment and 11 to watchful waiting.

“We have followed these patients for up to six months,” Peter Gardiner, Blue Earth Diagnostics CMO, told MD+DI. “As far as longer term follow up for these patients – that something we’ve been talking about. It’s not currently planned, but it’s something that we continue to discuss.”

Allis said that the study legitimizes the diagnostic and shows how it can be useful.

“I think the results show that this test has the potential to change patient management,” Allis said. “That’s key. There is a big decision to make for these patients. What happens next for them? What kind of therapy do they get? LOCATE starts that understanding of what value having a PET living scan brings to those patients.”