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Development of a Ready-to-Use PSMA-11 Kit formulation and Biological Evaluation of Binding Affinity

Advances in Molecular Imaging 2024年第2期13卷 7-22页

作者： maria renata valente brandão f.eire Natália Marchesan Bexiga Marco Antonio Stephano João Ezequiel oliveira Carlos Roberto Jorge Soares Ana Cláudia Camargo Miranda Anna Carolina de Alcântara Barbosa Marycel figols de Barboza Laura fernanda Garcia Luiz felipe S. Teixeira maria Helena Marumo Bellini Natanael Gomes da Silva Luiza Mascarenhas Balieiro Joel Mendes Elaine Bortoleti de Araújo Centro de Radiofarmcia Instituto de Pesquisas Energticas e Nucleares (IPEN) Cidade Universitria So Paulo Brasil Departamento de Tecnologia farmacutica Faculdade de Cincias Farmacuticas (USP) Cidade Universitria So Paulo Brasil Centro de Biotecnologia Instituto de Pesquisas Energticas e Nucleares (IPEN) Cidade Universitria So Paulo Brasil Departamento de Medicina Nuclear do Hospital Israelita Albert Einstein So Paulo/SP Brasil

Introduction: 68Ga-PSMA-11 is considered the gold standard in detection of micro and oligometastases in advanced prostate cancer, being used for therapeutic planning, as well as, potentially, for evaluating response to treatment. The development of ready-to-use lyophilized kit of PSMA-11 adds quality and safety to the routine use of this radiopharmaceutical and represents a pharmacotechnical challenge as it must preserve the integrity and specificity of the ligand. Methods: PSMA-11 kit formulation was proposed, considering radiolabeling parameters and the preservation of the peptide during the lyophilization process, using mannitol as an excipient. Critical temperature characterization studies were carried out using DSC equipment and the freeze-drying process was developed. The direct radiolabeling conditions were evaluated and standardized using 68Ge/68Ga generator eluate from two different manufacturers (ITG and Eckert & Ziegler). The radiochemical purity was evaluated by TLC and HPLC. Biological evaluation was carried out with lyophilized PSMA-11 to demonstrate the integrity of the peptide and preservation of biological activity after the lyophilization process. Results: Based on critical temperature characterization studies, the freeze-drying cycle was designed to reach a freezing temperature of around −40˚C and primary drying at 2˚C. Using 20 mg of mannitol, an intact and elegant lyophilized cake was obtained. PSMA-11 lyophilized kit was directly labeled with 68Ga eluate from 68Ge/68Ga GMP generators (ITG and Eckert & Ziegler) resulting in % RP > 95% at pH 4.0 to 4.5. The results obtained from in vitro and in vivo biological competition studies confirmed the preservation of PSMA-11 affinity for the receptor after lyophilization. Conclusion: A lyophilized formulation (Kit) of PSMA-11 was successfully obtained, which preserved the integrity and biological activity of the peptide and guaranteed radiolabeling efficiency.

关键词： 68Ga-PSMA-11 Prostate-Specific Membrane Antigen (PSMA) Ready-to-Use Kit GMP-Grade Generators Metastatic Prostate Cancer PET Imaging

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Relationship of Density of Specific Prostate Antigen (DPSA) with Prostate Histopathology: A Comparative Study of Patients Addressed in a School Hospital

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Journal of Biosciences and Medicines 2017年第3期5卷 105-111页

作者： Marcos Benedito figueiredo brandã o maria Benedita figueiredo brandã o Elias Sobreira Sathler Richard Raphael Borges Tavares Vieira Carolina Cadinelli Vieira Pedro Kozlowsky de Alencar Marcus Vinicius de Mello Pinto Lamara Laguardia valente Rocha Lina Claudia Pereira Lopes Daniel Almeida da Costa Carlos Henrique Diniz Branco Luiz Gioseffi Jannuzzi School Hospital of the Dom Andre Arcoverde foundation Valen&ccedil a Brazil Universidade Está cio de Sá Rio de Janeiro Brazil The Medical School at the Center of Higher Education of Valenç a Valen&ccedil a Brazil The Cellurare Institute Center of Laser Treatment and Cell Therapy Petr&oacute polis Brazil The Medical School at the Health Sciences Institute of the University Center of Caratinga Caratinga Brazil

Background: The prostate is the site of problems that have great clinical relevance. Beside this, the alterations in their volume can be divided into benign or malignant pathologies, but of multifactorial cause and there is no examination that alone is reliable for the diagnosis. Despite the evolution of the various methods of diagnostic imaging in the evaluation of pelvic diseases, the diagnosis of prostate cancer still requires histological confirmation obtained by transrectal ultrasound guided biopsy, a procedure that is generally safe and well tolerated by the patients. The most common histological type found in prostate biopsies is adenocarcinoma. Methodology: The objective of this study was to study the values of density of the prostate-specific antigen (DPSA) compared to histopathological results of prostate biopsy, patients attended at the Urology outpatient Clinic of the Luiz Gioseffi Jannuzzi School Hospital from 1999 to 2007, using Exploratory, retrospective and documentary descriptive study. The sample was divided into groups of patients with adenocarcinoma and patients without adenocarcinoma, who presented only benign prostatic hyperplasia. Results: of the 251 patients undergoing prostate biopsy, 124 were diagnosed with adenocarcinoma and 127 without adenocarcinoma. It was observed in this study that the DPSA was higher in adenocarcinoma than in the cases of patients with prostatic hyperplasia alone, and could therefore be used as an auxiliary tool in both diagnosis and follow-up of patients with adenocarcinoma. Conclusion: In this study, it can be observed that DPSA was higher in patients presenting with adenocarcinoma than in patients presenting only Benign Prostatic Hyperplasia (BPH), reinforcing its promising role to assist in the diagnosis and follow-up of patients with adenocarcinoma.

关键词： Prostate Cancer Adenocarcinoma Benign Prostatic Hyperplasia Prostate Biopsy

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