Blue Earth Diagnostics Announces Results of Additional Analyses from LOCATE Trial Evaluating Change in Recurrent Prostate Cancer Management Following Axumin® (Fluciclovine F 18) PET/CT Imaging

San Francisco, CA (UroToday.com) -- Presentations at AUA 2019 explore Axumin® detection rate and relationship to PSA levels, based on the extent of recurrence and prior treatment. Blue Earth Diagnostics, a molecular imaging diagnostics company, announced results of additional analyses from the LOCATE clinical trial (NCT02680041) in two presentations at the American Urological Association’s 2019 Annual Meeting, AUA 2019, May 3-6, 2019 in Chicago, Ill. The LOCATE trial was a prospective, U.S., multicenter, open-label study investigating the impact of 18F-fluciclovine PET/CT imaging on patient management of biochemically recurrent prostate cancer after initial prostate cancer treatment and negative or equivocal findings on standard-of-care imaging.
“Results of the study indicated an overall detection rate of 57% (122/213) for 18F-fluciclovine PET/CT in identifying lesions, that increases with increasing PSA and is higher among patients with intact prostate than those had previously undergone radical prostatectomy. As well, pelvic region detection rates were broadly proportional to baseline PSA.”
An oral presentation summarized LOCATE study results describing the sites of suspected recurrent prostate cancer in 213 patients, according to PSA levels, to investigate the potential for 18F-fluciclovine PET/CT to evaluate oligometastatic disease (evidence of limited recurrent disease potentially amenable to local treatment). Results indicated that patient level and pelvic region detection rates were broadly proportional to baseline PSA, with clinically important detection noted in pelvic nodes (9.3%), retroperitoneal nodes (5.6%) and bone (6.5%). In total, 25% (53/213) patients had oligometastatic disease. Twenty (38%) of the oligometastatic patients had PSA ≤ 1.0 ng/mL.

A poster presentation detailed LOCATE study results which evaluated the detection rate (DR) of 18F-fluciclovine PET/CT in men with prostate cancer recurrence with or without radical prostatectomy (RP). The overall DR for 18F-fluciclovine PET/CT was 57% (122/213) and was broadly proportional to the pre-scan PSA level, ranging from 31% (25/81) to 95% (18/19) among patients with a PSA of more than 10ng/mL.

Axumin® (fluciclovine F 18 injection) is an FDA-approved molecular imaging agent for use in positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate specific antigen (PSA) following prior treatment. (For additional product information please see the end of this news release.)

“In line with our mission to develop and commercialize innovative PET imaging agents for cancer, Blue Earth Diagnostics conducted the U.S.-based LOCATE study to evaluate the utility of 18F-fluciclovine PET/CT in providing physicians with actionable information for the management of men with recurrent prostate cancer,” said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. “We are very pleased to share results from additional analyses of the LOCATE study with the prestigious urology community at AUA2019.”

“The LOCATE study evaluated men with biochemically recurrent prostate cancer who had conventional imaging scans which were either negative or equivocal, and compared their treatment plans before and after 18F-fluciclovine PET/CT to assess whether or not it impacted their management,” said Gerald L. Andriole, MD, the Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Washington University School of Medicine in St. Louis and lead author on behalf of the LOCATE study group. “Results of the study indicated an overall detection rate of 57% (122/213) for 18F-fluciclovine PET/CT in identifying lesions, that increases with increasing PSA and is higher among patients with intact prostate than those had previously undergone radical prostatectomy. As well, pelvic region detection rates were broadly proportional to baseline PSA.”
Dr. Andriole continued, “Prostate cancer will recur in up to 30% of patients after initial treatment. In this study, for example, 25% (53/213) of patients had oligometastatic disease, with 38% (20/53) having PSA levels of less than or equal to 1.0 ng/mL. The ability to determine the extent and location of recurrent prostate cancer, in conjunction with other available clinical information, can inform the management plan for men with recurrent disease.”

About the LOCATE 18F-fluciclovine PET/CT Presentations at AUA2019
Sites of prostate cancer recurrence delineated with 18F-fluciclovine positron emission tomography in patients with negative or equivocal conventional imaging
The oral presentation characterized sites of recurrence according to PSA using data from LOCATE, and explored the potential for 18F-fluciclovine PET/CT to evaluate oligometastatic disease. Eligible men underwent 18F-fluciclovine PET/CT according to standard protocols, with results for 213 patients stratified by baseline PSA levels. Oligometastatic disease was defined as 1–5 extraprostatic lesions (≤ 3 lesions in any single organ system) in men with negative prostate/bed imaging (as a surrogate for primary tumor control). 18F-fluciclovine PET/CT detected lesions in 57% (122/213) of men. Patient level and pelvic region detection rates were broadly proportional to baseline PSA. At PSA < 1.0 ng/mL, substantial detection was noted in pelvic nodes at a rate of 9.3% (10/107), in retroperitoneal nodes at a rate of 5.6% (6/107) and in bone at a rate of 6.5% (7/107). In total, 53/213 (25%) had oligometastatic disease; 52 (24%) with 1–3 metastases and 1 (0.5%) with 5 metastases. Twenty (38%) of the oligometastatic patients had PSA ≤ 1.0 ng/mL.

Localization of recurrence of prostate cancer with 18F-fluciclovine positron emission tomography in patients with and without prior prostatectomy: Results from LOCATE
The poster presentation described data from the LOCATE study to evaluate the detection rate (DR) of 18F-fluciclovine PET/CT in men with prostate cancer recurrence with or without radical prostatectomy (RP). Eligible men underwent 18F-fluciclovine PET/CT imaging according to standard protocol at one of 15 U.S. centers. Scan findings for 213 patients were stratified according to patients’ prior therapy and baseline characteristics. In total, 164/213 (77%) men had RP prior to enrollment. PSA levels ranged more widely among the prior RP group compared with the intact prostate group, although the intact prostate group had a higher median PSA. 18F-Fluciclovine-avid lesions were found in 122 (57%) men, with a DR of 49% (81/164) in men with prior RP and 84% (41/49) in the intact prostate group. The overall DR was broadly proportional to the pre-scan PSA and ranged from 31% among those with a PSA < 0.5 ng/mL to 95% among patients with a PSA > 10 ng/mL. In the prior prostatectomy group, the DR ranged from 31% at PSA < 0.5 ng/mL to 95% at PSA > 10 ng/mL. In this cohort of men with PSA-recurrence but negative/equivocal standard imaging, the majority were shown to have one or more lesion by 18F-fluciclovine PET/CT. The DR increased with increasing PSA and was higher among patients with intact prostate than those who had previously undergone RP.

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