Abstract
The prostate cancer is the second most prevalent disease among men in Brazil, moreover PSMA therapy could change this scenario and its perspectives. IPEN-CNEN is the Brazilian industrial radiopharmacy center that produces radiopharmaceuticals for therapy. The production of 177Lu-PSMA-617 was evaluated in batches until 37 GBq and showed that the combination of ascorbate buffer, adequate radioactive concentration and freezing promoted the stability of the radiopharmaceutical for 48 hours, enabling transport of 177Lu-PSMA-617 to distant regions of the country.
Highlights
In Brazil, just like in other countries, prostate cancer is a common disease among men
To facilitate the distribution of therapeutic radiopharmaceuticals and, thereby, enable the development of clinical trials with 177Lu-PSMA-617 in Brazil, this study evaluated the effect of radiolysis on the scale up to produce industrial batches of this radiopharmaceutical and on the fractionated doses for transport
The effect of the temperature on the stability for 177Lu-PSMA-617 was evaluated using activity of 740 MBq, and the results showed that the product stored at room temperature was not stable, since the Radiochemical purity (RCP) decreased from around 98% to 80.4% ± 6.3% (n=3) after 24 hours
Summary
In Brazil, just like in other countries, prostate cancer is a common disease among men. The PSMA therapy has brought new perspectives for patients with multi metastatic resistant prostate cancer. The Nuclear and Energy Research Institute of the National Nuclear Energy Commission (IPENCNEN, São Paulo/Brazil) is an industrial radiopharmacy center that produces radiopharmaceuticals for therapy in batches for large distribution. The effect of radiolysis on therapeutic doses of radiopharmaceuticals can be avoided or mitigated by diluting the final dose and reducing the temperature for storage and transportation [4]. To facilitate the distribution of therapeutic radiopharmaceuticals and, thereby, enable the development of clinical trials with 177Lu-PSMA-617 in Brazil, this study evaluated the effect of radiolysis on the scale up to produce industrial batches of this radiopharmaceutical and on the fractionated doses for transport
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