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GenesisCare is expanding access to PSMA-PET imaging to all of its US sites by mid-2022, according to a news release from the oncology provider.1
Specifically, GenesisCare will enable patient access to the PSMA-PET imaging agent piflufolastat F 18 (Pylarify), which the FDA approved in May 2021 for identifying suspected metastasis or recurrence of prostate cancer. The first US patient to receive piflufolastat F 18, Leonard Bitterman, was treated at GenesisCare in Boca Raton, Florida, on June 3, 2021.
"Innovative diagnostic tools like PSMA-PET provide more accurate and earlier detection of disease than conventional imaging so our clinicians, along with their patients and families, can make more informed treatment decisions that lead to improved outcomes," Neal D. Shore, MD, FACS, GenesisCare Chief Medical Officer of Urology and Surgery and National Urology Research Director, stated in the news release.
"We are very excited to offer PSMA PET imaging with the first FDA-approved and commercially available PSMA -PET prostate cancer imaging agent, Pylarify, to all of our patients throughout the United States," added Shore.
The FDA approval of piflufolastat F 18 was based on findings from the CONDOR and OSPREY studies. In the CONDOR study, 63.9% of men with biochemically recurrent prostate cancer who had no evidence of disease on standard-of-care imaging had a change in intended management after their piflufolastat F 18 scan.2
The multicenter phase 3 CONDOR study enrolled men with rising PSA after definitive therapy and negative or equivocal standard-of-care imaging. Patients were required to have a PSA level ≥0.2 if they had undergone radical prostatectomy (RP) or a PSA level ≥2.0 if they were treated with radiation therapy or cryotherapy.
The primary end point was correct localization rate (CLR), defined as percentage of patients with a 1:1 correspondence between at least 1 lesion identified by PyL–PET/CT and the composite standard of truth (pathology, correlative imaging, or PSA response). PyL scans were read by 3 blinded independent central readers.
Overall, there were 208 evaluable patients, about 85% of whom underwent RP, either alone or with radiation. Median PSA level of the cohort was 0.8 ng/mL, and 68.8% had a PSA level <2.0 ng/mL. Some 27.9% had received at least 1 prior systemic therapy.
Detection of disease as manifested by a positive 18F-DCFPyL–PET/CT scan was 65.9%, 59.6%, and 59.1% by the 3 readers.
The prespecified criterion for CLR success was for the lower limit of the 95% CI to exceed 20% for at least 2 of the 3 readers. For every reader, the lower bound of the 95% CI for the CLR was well in excess of the 20% benchmark, meeting the primary end point of the study.
The CLRs were 85.6% (95% CI, 78.8%-92.3%), 87.0% (95% CI, 80.4%-93.6%), and 84.8% (95% CI, 77.8%-91.9%) by the 3 readers. Some 64% of the evaluable patients had a change in intended management due to the scan.
In September 2021, it was announced that the NCCN had added Ga 68– and F 18–based PSMA-PET imaging modalities to its clinical practice guidelines for prostate cancer.3
"PSMA-PET is a revolutionary diagnostic tool we're now offering nationwide that allows doctors to see metastatic or recurrent prostate cancer earlier—anywhere in the body. This is a game-changer that will have a tremendous impact for patients across the United States," Dan Collins, founder and CEO, GenesisCare, stated in the news release. "Through continued collaborations with medical imaging and theranostics leaders like Lantheus, GE, Telix and Clarity, and our leading team of global theranostics experts, we are able to bring the latest breakthroughs in cancer diagnostics and treatment to more patients, much faster."
1. GenesisCare Expands PSMA PET Imaging to All U.S. Centers Improving Precision in Prostate Cancer Diagnoses and Treatment. Published online October 28, 2021. Accessed November 2, 2021. https://prn.to/3mBo7Xi.
2. Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase 3, multicenter study [published online before print February 26, 2021.] doi: 10.1158/1078-0432.CCR-20-4573
3. NCCN Guidelines Updated to Include PSMA-PET Imaging. Posted online September 13, 2021. Accessed September 15, 2021. https://bit.ly/3kbCgJF.