Logistical, technical, and radiation safety aspects of establishing a radiopharmaceutical therapy program - A case in Lutetium-177 prostate-specific membrane antigen (PSMA) therapy

Sep 24, 2026

Uploaded by Noah

Prostate-specific membrane antigen (PSMA) is a cell-surface protein highly expressed in most prostate cancers, motivating PSMA-targeted radiopharmaceutical therapy strategies. With FDA approval in March 2022 for lutetium-177 PSMA-617 (Lu-177-PSMA-617) in PSMA-positive metastatic castration-resistant prostate cancer after prior androgen receptor pathway inhibition and taxane chemotherapy, implementation is expected to expand. This article details logistical, technical, and radiation safety considerations, emphasizing the development of operating procedures for therapeutic administrations and outlining major center tasks with Lu-177-PSMA-617 examples.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Introduction

Radiopharmaceutical therapy background and rationale

Lu-177 PSMA-617 properties and clinical context

Implementation task list for a radiopharmaceutical therapy (RPT) program

Learn about the therapy

Allocate resources

Staffing

Equipment

Space

Satisfy radioactive material (RAM) use regulations

Generate written procedures and accompanying forms

Patient eligibility, schedule coordination, and informed consent

Logistical, technical, and radiation safety aspects of the source/drug

DOI: 10.1002/acm2.13899 OTHER TOPICS Logistical, technical, and radiation safety aspects of establishing a radiopharmaceutical therapy program: A case in Lutetium-177 prostate-speciﬁc membrane antigen (PSMA) therapy Jacqueline E. Zoberi1 Jose Garcia-Ramirez1 David Luechtefeld2 Nichole M. Maughan1 Maxwell Amurao2 Reiko Oyama3 Brian C. Baumann1 Hiram A. Gay1 Jeff M. Michalski1 1 Department of Radiation Oncology, Washington University School of Medicine, Saint Louis, Missouri, USA 2 Environmental Health and Safety, Washington University School of Medicine, Saint Louis, Missouri, USA 3 MIR Cyclotron Facility and Nuclear Pharmacy, Washington University School of Medicine, Saint Louis, Missouri, USA Correspondence Jacqueline E. Zoberi, Department of Radiation Oncology, Washington University School of Medicine, Saint Louis, MO 63110, USA. [Email:](Email: jesthappan@radonc.wustl.edu)[ jesthappan@radonc.wustl.edu](Email: jesthappan@radonc.wustl.edu) Abstract Prostate-speciﬁc membrane antigen (PSMA) is a cell surface protein highly expressed in nearly all prostate cancers, with restricted expression in some normal tissues. The differential expression of PSMA from tumor to non-tumor tissue has resulted in the investigation of numerous targeting strategies for therapy of patients with metastatic prostate cancer. In March of 2022, the FDA granted approval for the use of lutetium-177 PSMA-617 (Lu-177-PSMA-617) for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. Therefore, the use of Lu-177-PSMA-617 is expected to increase and become more widespread. Herein, we describe logistical, technical, and radiation safety considerations for implementing aradiopharmaceutical therapy program, with particular focus on the development of operating procedures for therapeutic administrations. Major steps fora center in the [U.S. to](U.S. to) implement a new radiopharmaceutical therapy (RPT) program are listed below, and then demonstrated in greater detail via examples for Lu-177-PSMA-617 therapy. KEYWORDS commissioning, QA/QC, radiopharmaceutical therapy, safety 1 INTRODUCTION (PSMA) is a cell surface protein highly expressed in nearly all prostate cancers, with restricted expression Radiopharmaceutical therapy (RPT) is a form of internal radiation therapy using unsealed radionuclides to emit energetic particles (beta,Auger, alpha) in close proximity to tumor cells for dose deposition. For some therapies, these radionuclides are joined to molecules to target the delivery of the radiation on the basis of speciﬁc biologic features to maximize dose to the tumor while sparing normal tissues. Prostate-speciﬁc membrane antigen in some normal tissues such as the small intestine, proximal renal tubules, and salivary glands.1 PSMA- 617 is a small molecule which shows a high binding afﬁnity to PSMA and efﬁcient internalization and retention with the cancer cells.1 PSMA-617 radio-labeled with lutetium-177 (Lu-177) enables PSMA-targeted radioligand therapy. Lu-177 has a physical half-life of 6.7 days and undergoes beta decay emitting beta This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2023 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, LLC on behalf of The American Association of Physicists in Medicine. particles with maximum energies (abundances) of 497 keV (78.6%), 384 keV (9.1%), 176 keV (12.2%) and low energy gamma photons with energies (abundances) of 208 keV (11%) and 113 keV (6 .6%) .2 The beta particles deposit most of their energy in tissue to less than 2 mm (mean penetration of less than 1 mm), and the gamma rays are generally useful for imaging the biodistribution.2–5 Biologic clearanc

FAQs

What is radiopharmaceutical therapy (RPT) and how does it work?

RPT is internal radiation therapy using unsealed radionuclides that emit energetic particles close to tumor cells. For some treatments, the radionuclides are attached to targeting molecules to maximize tumor dose while sparing normal tissues.

Why is Lu-177-PSMA-617 used for prostate cancer treatment?

PSMA is highly expressed in most prostate cancers, and PSMA-617 binds with high affinity, followed by internalization and retention in cancer cells. Lutetium-177 enables PSMA-targeted radioligand therapy and supports imaging of biodistribution via low-energy gamma emissions.

What major steps must a center follow to implement a new RPT program?

The article outlines key tasks: learn about the therapy, allocate resources (staffing, equipment, space), satisfy radioactive material regulations, and generate written procedures and forms. It also stresses patient eligibility, schedule coordination, informed consent, and source/drug logistical, technical, and radiation-safety documentation.

Sep 24, 2026

Uploaded by Noah