The situation of the Brazilian radiopharmacy scenario for diagnosis, treatment and staging of prostate cancer

Cancer is one of the biggest public health concerns in the world. In Brazil, itis the second largest cause of mortality in Brazil, according to the National Cancer Institute (INCA). The prostate cancer accounted for approximately 68.2 thousand new cases in the biennium 2018-2019. The diagnosis and response to treatment in prostate cancer is a significant challenge faced by oncologists and radiologists worldwide. The determination of this pathology and its stages can be confirmed by rectal examination, PSA dosage, abdominal and transretal ultrasonography, biopsy, magnetic resonance imaging (MRI), and nuclear medicine. However, even with complementary methods of PSA levels associated with advances in ultrasound and MRI technologies, the medical images have their limitations regarding diagnosis, staging, and prognosis. Both radiological imaging and PSA levels evaluation methods show high percentage of false positives and negatives during the screening due the confounding effects of benign prostatic hyperplasia and prostatitis. Therefore, other more specific and less invasive diagnostic methods such as PET/CT (positron emission tomography/computed tomography) and more recently, PET/MRI, are proposed. Such technologies bring molecular imaging as an essential tool in the diagnosis and staging of prostate cancer. In nuclear medicine, 11C-Choline and 18F-FCH radiopharmaceuticals were the gold-standard for several years for prostate cancer evaluation. Nowadays, the state-of-the-art worldwide for such purpose uses short-lived radiopharmaceuticals with greater effectiveness, i.e., 68Ga-PSMA-11, 18F-PSMA-1007, 18F-DCPL, among others. The objective of this work was to present the Brazilian scenario in industrial-scale production and the use of radiopharmaceuticals for diagnosis and staging of the prostate cancer. As a result, we found that only 68Ga-PSMA-11 produced by 68Ge/68Ga generators with Good Manufacturing Practice (GMP) certificate is available in the Brazilian scenario.Unfortunately, we did not find reports of industrial-scale production of68Ga-PSMA-11 by 68Ga production with cyclotrons,18F-FACBC, Al18F-PSMA-11, 18F-PSMA-1007, 18F-DCPyL, and 64Cu-PSMA-617. To our knowledge, there is no cyclotron facility producing neither 68Ga-PSMA-11 nor 18F-based radiopharmaceuticals for prostate cancer in Brazil. Our work encourages the Brazilian cyclotrons facilities to put strengthin production, development and distribution of such radiopharmaceuticals for diagnostic and therapy.