Release date: 2016-06-02
           
The US Food and Drug Administration (FDA) has approved Fluciolovine (18F) for screening and detection of recurrent prostate cancer. The drug is an injectable radiopharmaceutical approved for PET imaging in patients with suspected recurrent prostate cancer.
Dr. Livero Marzella said: "In the case of very low levels of PSA, it is difficult to specifically locate the lesions of recurrent prostate cancer in imaging studies."
Fluciclovine is a good indicator of the location of the lesion and is a more accurate imaging examination, Dr. Marzella said.
Fluciclovine is a synthetic amino acid that can be actively transported by specific amino acid carriers and has been shown to be efficiently absorbed by prostate cancer cells.
The FDA approved the use of the drug based on two studies on the safety and efficacy of Fluciolovine.
In the first trial, 105 patients with suspected prostate cancer recurrence were screened with Fluciolovine and compared with the patient's pathology. The pathological section was read by four independent pathologists.
The second study compared Fluciolovine with C11 choline, a reagent that has been approved for PET imaging, and screened patients with a median PSA level of 1.44 ng/ml.
The FDA noted: "The results confirm the safety and efficacy of [Fluciclovine] in the imaging of prostate cancer patients." The reagents cause very few adverse events, the most common is the injection site pain, redness, mouth Metallic.
Source: Bio 360
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