Therapy

Publications
Articles and Abstracts
BACKGROUND
Metastatic castration-resistant prostate cancer remains fatal despite recent advances. Prostate-specific membrane antigen (PSMA) is highly expressed in metastatic castration-resistant prostate cancer. Lutetium-177 (177Lu)–PSMA-617 is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells and the surrounding microenvironment.

Purpose of the study: To report the safety evaluation of 177Lu-PSMA-617 derived from the cohort of 64 patients exposed to 177Lu-PSMA-617 in the RESIST-PC trial NCT03042312 Methods: RESIST-PC was a prospective multicenter phase 2 trial.

Objective: To determine prospectively the efficacy profile of 2 activity regimens of Lu-PSMA therapy in patients with progressive metastatic castrate resistant prostate cancer (mCRPC): 6.0 vs 7.4 GBq.

Physician-Scientist Review Articles
State of the Evidence Review Articles
Written by Christopher J.D. Wallis, MD, PhD, University of Toronto, Toronto, Ontario, Canada and Zachary Klaassen, MD, MSc, Medical College of Georgia, Augusta, Georgia, USA
August 24, 2021
In spite of the rapid progress and many exciting advances in the treatment of metastatic castration-resistant prostate cancer over the past few years, the disease remains incurable with a median overall survival of 12-35 months.1-4
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Ajeet Gajra FACP, MD
Dr. Garja presented a poster focused on understanding how community-based medical oncologists plan to integrate 177Lu-PSMA-617 into patient management. How 177Lu-PSMA-617 approval will affect the treatment landscape of mCRPC depends on how community-based medical oncologists uptake this new treatment approach.
Presented by Ken Herrmann, MD, MBA
During the 2022 GU ASCO Cancer Symposium, Dr. Herrmann presented a poster assessing [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) dosimetry among patients treated on the phase 3 VISION trial (NCT03511664).
Presented by Brian Gonzalez PhD
During the ASCO GU Symposium 2022, Dr. Gonzalez presented work on patient-reported quality of life metrics among men receiving prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
Presented by Michael J. Morris, MD
(UroToday.com) The Society of Urologic Oncology (SUO) annual winter meeting included an advanced prostate cancer session and a presentation by Dr. Michael Morris discussing the VISION trial and integration of PSMA-targeted therapy for advanced prostate cancer.
Presented by Scott T. Tagawa
(UroToday.com) PSMA-targeted radionuclide therapy (TRT) is one of the most promising investigational therapies in prostate cancer currently. In the phase II TheraP trial and the phase III VISION trial, 177-lutetium-PSMA-617 has demonstrated better outcomes compared to the current standard of care treatment options for patients who have received many lines of therapy for metastatic castration resistant prostate cancer (mCRPC). 
Presented by Eleni Efstathiou, MD

The APCCC 2021 meeting session discussing PSMA in diagnostics and therapy included a presentation by Dr. Eleni Efstathiou discussing the contagious enthusiasm of PSMA-driven therapeutics. 

 

Presented by Charles Ryan, MD
The Advanced Prostate Cancer Consensus Conference 2021 virtual meeting session discussing PSMA in diagnostics and therapy included a presentation by Dr. Charles Ryan discussing the best use of Lutetium-PSMA and where to place it when sequencing therapies, including treatment monitoring.
Presented by Michael J. Morris, MD
(UroToday.com) Lutetium-177 is a radioligand that when bound to a prostate-specific membrane antigen (PSMA) targeting molecule delivers beta-particle radiation to PSMA-expressing cells and their local microenvironment.
Presented by Karim Fizazi, MD, PhD
 The ESMO 2021 annual meeting’s prostate cancer mini oral session included a presentation by Dr. Karim Fizazi discussing health-related quality of life, pain, and safety outcomes in the phase 3 VISION study. [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) delivers β-particle radiation to prostate-specific membrane antigen (PSMA) expressing cells and the surrounding microenvironment.
Presented by Brian D. Gonzalez, PhD
(UroToday.com) The European Society of Medical Oncology (ESMO) 2021 annual meeting’s prostate cancer session included a presentation by Dr. Brian Gonzalez discussing patient-reported outcomes in prostate cancer patients receiving prostate-specific membrane antigen (PSMA) radionuclide therapy. PSMA targeted radionuclide therapy is a promising investigational therapy for patients with progressive metastatic castration-resistant prostate cancer (mCRPC), conjugating a radionuclide emitting alpha radiation (e.g., Actinium-225) or beta radiation (e.g., Lutetium-177) to a small molecule ligand (e.g., PSMA-617) or a monoclonal antibody (e.g., J591) that has an affinity for PSMA. 
Presented by Michael Morris, MD
In the on-demand poster session of the ESMO Annual Congress, Dr. Morris provided a summary of the PSMAfore trial in progress (NCT04689828). This study examines the role of [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) in taxane-naïve patients with mCRPC.
Presented by Scott T. Tagawa, MD
(UroToday.com) In the on-demand poster session of the European Society for Medical Oncology (ESMO) Annual Congress, Dr. Scott Tagawa reported results of a phase I/II study of dose-escalation study of a fractionated (dose-dense) treatment regime of 177Lu-PSMA-617 for metastatic castration-resistant prostate cancer (mCRPC). Previously reported, the initial phase I data from this study demonstrated no evidence of short-term dose-limiting toxicity.
Presented by Scott T. Tagawa, MD
(UroToday.com) In the on-demand poster session of the European Society for Medical Oncology (ESMO) Annual Congress, Dr. Scott Tagawa presented a trial in poster summary of the PSMAddition trial. This trial was launched given the proven benefits of [177Lu]Lu-PSMA-617 (177Lu-PSMA-617). 177Lu-PSMA-617 is a high-affinity prostate-specific membrane antigen (PSMA)-targeted radioligand therapy that delivers β-particle radiation to cells that express PSMA, as well as the surrounding microenvironment. 
Presented by Scott Tagawa, MD
(UroToday.com) The advanced prostate cancer session at the 2021 American Urologic Association (AUA) annual meeting included a presentation by Dr. Scott Tagawa who discussed long-term follow-up and prognostic factor analysis among men with mCRPC who received 177Lu-PSMA therapy. PSMA-targeted radionuclide therapy has recently emerged as a promising treatment modality for advanced prostate cancer. 
Presented by Silke Gillessen, MD
Silke Gillessen discussed the recently published TheraP1 and VISION2 trials. Dr. Gillessen notes that in the metastatic castration-resistant prostate cancer (mCRPC) setting, we now have several treatment options that offer a survival benefit, including abiraterone, cabazitaxel, docetaxel, enzalutamide, radium-223, sipuleucel-T, olaparib, and now 177Lu-PSMA-617.
Presented by Karim Fizazi, MD, Ph.D
Dr. Karim Fizazi finished off the thematic session of Treatment Sequencing in Metastatic Prostate Cancer with a presentation on the role of PSMA in diagnostics and treatment of metastatic prostate cancer.
Presented by Gero Kramer, MD
(UroToday.com)  Dr. Gero Kramer reviews the systemic treatment options for metastatic castration-resistant prostate cancer (mCRPC) and highlights some recent developments.
Presented by Johann De Bono, MD, MSc, Ph.D., FRCP, FMedSci
The EAU 2021 Annual Meeting included a presentation by Johann De Bono discussing the VISION trial, a phase 3 study of 177Lu-PSMA-617 in patients with mCRPC. As PSMA is highly expressed in prostate cancer and mCRPC lesions, the combination of PSMA-617 with the beta-emitter lutetium allows for the targeted delivery of ß-particle radiation to PSMA-expressing cells and the surrounding microenvironment.
Presented by Michael Morris, MD
(UroToday.com) There has been a dramatic and rapid proliferation of systemic therapy options in advanced prostate cancer since the introduction of docetaxel for metastatic castration resistant prostate cancer (mCRPC) in 2004. These newer treatments have included a number of novel hormonal therapies (including abiraterone acetate and enzalutamide),
Presented by Madhav P. Yadav, MD
(UroToday.com) Beginning with the introduction of docetaxel for metastatic castration resistant prostate cancer (mCRPC) in 2004, there has been a dramatic and rapid proliferation of systemic therapy options in advanced prostate cancer including a number of novel hormonal therapies (including abiraterone acetate and enzalutamide), second-line chemotherapy (cabazitaxel), bone-targeting agents (radium-223) and other targeted agents (including olaparib, rucaparib, and pembrolizumab), each of which has proven survival benefits. 
Presented by Hossein Jadvar, MD
(UroToday.com) The Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2021 annual meeting included a metastatic castrate-resistant prostate cancer (mCRPC) session and a presentation by Dr. Hossein Jadvar discussing alpha-emitting PSMA molecular radiotherapy in mCRPC. Dr. Jadvar notes that the lethal potency of alpha particles includes
Presented by Mary-Ellen Taplin, MD
(UroToday.com)  Dr. Taplin began her discussion of the VISION trial by first reviewing the current therapeutic landscape of prostate cancer. While there are many life-prolonging options, unfortunately, the duration of response to these therapies in sequence is often short. The VISION trial was set up to evaluate the use of lutetium-PSMA in late-stage advanced prostate cancer
Presented by Michael J. Morris, MD
(UroToday.com) In this presentation, Dr. Michael Morris presented the results of the phase 3 VISION trial evaluating the radiopharmaceutical lutetium-PSMA (Lu-PSMA) in patients with metastatic castration-resistant prostate cancer.
Presented by Mary-Ellen Taplin, MD
Following Micheal Morris’s presentation of the results of the phase III VISION trial of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer in the Plenary Session of the 2021 ASCO, Dr. Mary-Ellen Taplin from the Dana Farber Cancer Institute provided a discussant overview of these data and helped to contextualize how we may apply them to our practices.
Presented by Micheal Morris, MD
In a plenary presentation at the 2021 ASCO Annual Meeting, Dr. Morris presented the first results of the VISION trial, a phase III study assessing lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer.
Presented by Mike Machaba Sathekge, MD, Ph.D
In a plenary presentation in the Progress and Promise in Treatment Personalization for Advanced Prostate Cancer session at the 2021 American Society of Clinical Oncology Genitourinary (Cancers Symposium (ASCO GU), Dr. Sathekge provided a talk examining the role of Lutetium in prostate cancer.
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