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The VISION Trial: Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
Videos
Lutetium-177 PSMA Radioligand Therapy for Advanced Prostate Cancer: Reviewing the Pivotal VISION and TheraP Trials - Michael Morris
PSMA and RLT: The VISION and TheraP Trials "Presentation" - Michael Morris
Predictive Markers in Metastatic Prostate Cancer: Insights from the VISION Trial - Oliver Sartor
A VISION Substudy of Reader Agreement on 68Ga-PSMA-11 PET/CT Scan Interpretation to Determine Patient Eligibility for 177Lu-PSMA-617 Radioligand Therapy - Beyond the Abstract
Assessing Reader Variability in PSMA-PET/CT Scan Interpretation: A Substudy of the VISION Trial, Journal Club - Rashid Sayyid & Zachary Klaassen
Improving mCRPC Outcomes: VISION Study Highlights Lu-PSMA-617 Impact on Survival and Quality of Life, Journal Club - Rashid Sayyid & Zachary Klaassen
From the VISION Trial: Improved Patient Outcomes with Lutetium-PSMA-617 - Karim Fizazi
Radiographic Progression-Free Survival Correlation with Time-to-Event Endpoints in the VISION Trial - Michael Morris
The Implementation of PSMA Theranostics in Clinical Practice - Oliver Sartor
Integrating 177Lu-PSMA-617 in Clinical Practice - Oliver Sartor
A Urologist's Perspective On the Integration of Lutetium Into Clinical Practices - Neal Shore
Pluvicto™ (177Lu-PSMA-617) Indications for Clinical Use in PSMA Positive Metastatic Castration-Resistant Prostate Cancer mCRPC - Oliver Sartor
Pluvicto The First Targeted Radioligand Therapy for Treatment of Metastatic Castration-Resistant Prostate Cancer FDA Approved - Charles Ryan and Alicia Morgans
Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer, The VISION Trial Journal Club - Christopher Wallis & Zachary Klaassen
Pain and Symptomatic Skeletal Events Reported in the VISION Trial – Oliver Sartor
Health-Related Quality of Life (HRQoL) From the Phase 3 VISION Study of 177Lu-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer – Karim Fizazi
The Clinical Implications of The VISION Trial, PSMA-Targeted Radiotherapy in Metastatic Prostate Cancer - Michael Morris
Transforming The Standard of Care for Men With Advanced-Stage PSMA-Positive mCRPC, Published Results from the Phase III VISION Trial - Oliver Sartor
The VISION Trial Demonstrates 177Lu-PSMA-617 Significantly Improves Overall Survival and rPFS in mCRPC – Oliver Sartor
177Lu-PSMA-617 Significantly Improves Overall Survival and Radiographic Progression-Free Survival in Metastatic Castration-Resistant Prostate Cancer in VISION study - Mary-Ellen Taplin
177LuPSMA-617 - A New Standard of Care in the Treatment of mCRPC Based on The Phase III VISION Trial Results - Michael Morris
The Impact of the COVID-19 Pandemic on Genitourinary Cancer Care - Re-envisioning the Future - Zachary Klaassen and Christopher J.D. Wallis
PSMA Targeted Radiopharmaceuticals in Prostate Cancer: Pivotal Phase III VISION Trial - Oliver Sartor
The VISION Trial: Radionuclide Therapy Plus Standard Therapy for Metastatic Castration Resistant Prostate Cancer - Oliver Sartor and Michael Morris
A Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer - The VISION Trial, Interview with Oliver Sartor
Publications
Articles and Abstracts
177Lu-PSMA therapy is an effective treatment in patients with metastatic castration-resistant prostate cancer. SUVmean is a valuable screening biomarker to assess the suitability for 177Lu-PSMA therapy but requires quantitative software.
The pivotal phase 3 VISION study used [68Ga]Ga-PSMA-11 (also known as 68Ga-PSMA-11) imaging to identify patients with metastatic castration-resistant prostate cancer eligible for [177Lu]Lu-PSMA-617 radioligand therapy, based on predefined read criteria. In this substudy of VISION, the inter-reader variability and intra-reader reproducibility of visual assessments of 68Ga-PSMA-11 positron emission tomography scans using the VISION read criteria were evaluated.

68Ga-gozetotide (68Ga-PSMA-11) is used to identify prostate-specific membrane antigen (PSMA)-positive tumors on PET scans. In the VISION study, 68Ga-PSMA-11 was used to determine the eligibility of patients with metastatic castration-resistant prostate cancer for treatment with 177Lu-vipivotide tetraxetan (177Lu-PSMA-617), based on predefined read criteria.

Novartis announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post-taxane-based chemotherapy setting.
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.
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Jean-Mathieu Beauregard, MD, MSc, FRCPC
The 2024 SNMMI annual meeting featured a session on prostate cancer, and a presentation by Dr. Jean-Mathieu Beauregard discussing a sub-analysis of the 3TMPO study assessing eligibility for PSMA radioligand therapy based on dual FDG/PSMA-PET. Eligibility criteria for PSMA radioligand therapy are currently debated, particularly with respect to the role of FDG-PET in patient selection.
Presented by Thomas Hope, MD
The 2024 SNMMI annual meeting was host to the session Novel Approaches and Combination Therapies; Pre-Targeting Approaches. Dr. Thomas Hope discussed the combination treatment of prostate cancer using Pembrolizumab with PSMA-based radioligands.
Presented by Meryam Losee, BS
At the SNMMI 2024 Annual Meeting, Dr. Meryam Losee presented the results of a study evaluating the effect of bone marrow disease on hematologic toxicity and PSA response to 177Lu-PSMA-617 therapy. 
Presented by Vishnu Murthy
At the SNMMI 2024 Annual Meeting Vishnu Murthy presented the results of a US expanded access program evaluating the efficacy and toxicity of 177Lu-PSMA-617 for metastatic castration-resistant prostate cancer (mCRPC) in a real-world setting and compared these results to those from the phase 3 VISION trial.
Presented by Oliver Sartor, MD
At the SNMMI 2024 Annual Meeting Dr. Oliver Sartor presented the updated results of PSMAfore, a phase 3 trial of [177Lu]Lu-PSMA-617 in taxane-naive patients with metastatic castration-resistant prostate cancer (mCRPC).
Presented by Oliver Sartor, MD
The SNMMI 2024 Annual Meeting was host to a prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) tumor board session. Dr. Oliver Sartor discussed whether earlier use of PSMA RLT in earlier settings is of clinical benefit.
Presented by Karim Fizazi, MD, PhD
The 2024 ASCO featured a session on prostate cancer, and a presentation by Dr. Karim Fizazi discussing results from PSMAfore, specifically health-related quality of life and pain among taxane-naïve metastatic castration-resistant prostate cancer (mCRPC) patients treated with 177Lu-PSMA-617. 
Presented by Ridvan Arda Demirci, MD
The 2024 GU ASCO annual meeting featured a prostate cancer session and a presentation by Dr. Ridvan Demirci discussing the association between PET-based TheraP eligibility and 177Lu-PSMA-617 outcomes in VISION-eligible patients with metastatic castration-resistant prostate cancer (mCRPC).
Presented by Ken Herrmann, MD
The 2024 ASCO GU cancers symposium was host to a prostate cancer poster session. Dr. Ken Herrmann presented the preliminary results of a predictive model for treatment outcomes with [177Lu]Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC), using data from the phase III VISION trial.
Presented by Michael Morris, MD
The 2024 PSMA conference featured a presentation by Dr. Michael Morris discussing the VISION1 and TheraP2 trials. Dr. Morris started by discussing the VISION trial, an international, randomized, open-label phase III study evaluating 177Lu-PSMA-617 in men with PSMA-positive mCRPC who had previously received treatment with a next-generation androgen receptor signaling inhibition (abiraterone, enzalutamide, etc) and one or two prior lines of taxane chemotherapy.
Presented by Xiao X. Wei, MD, MAS
The 2023 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Xiao Wei discussing a post hoc analysis of the VISION trial assessing the prognostic value of neutrophil-to-lymphocyte ratio and lymphopenia in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA-617.
Presented by Michael Morris, MD
The 2023 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Michael Morris discussing the association of health-related quality of life with efficacy outcomes in the VISION study of patients with metastatic castration-resistant prostate cancer (mCRPC).  
Presented by Anushna S. Babu, MD
The 2023 SNMMI annual meeting included a prostate cancer session, featuring a presentation by Dr. Anushna Babu discussing dual PSMA/FDG PET/CT for assessing eligibility and predicting response in mCRPC patients undergoing 177Lu-PSMA-617 radioligand therapy.
Presented by Ken Herrmann, MD
The 2023 ASCO annual meeting included a prostate cancer session, featuring a presentation by Dr. Ken Herrmann discussing preliminary results of building a predictive model for outcomes with 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) using VISION data.
Presented by Prof. Bernd J. Krause
The 2023 ASCO annual meeting included a prostate cancer session, featuring a presentation by Dr. Bernd Krause discussing a VISION trial sub-study analysis assessing tumor dosimetry of 177Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
Presented by Yu Yang Soon, NHMRC
The 2023 ASCO annual meeting included a prostate cancer session, featuring a presentation by Dr. Yu Yang Soon discussing an exploratory analysis of the effects of 177Lu-PSMA-617 (LuPSMA) on overall survival in TheraP versus VISION randomized trials.
Presented by Ken Herrmann, MD
 The 2023 ASCO annual meeting included a prostate cancer session, featuring a presentation by Dr. Ken Herrmann discussing preliminary results of building a predictive model for outcomes with 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) using VISION data.
Presented by Scott T. Tagawa, MD, MS, FACP
At the Annual Meeting of the Society of Urologic Oncology there was a session focused on prostate specific membrane antigen (PSMA) and prostate cancer. In the context of this session, Dr. Scott Tagawa presented on the evolving role of prostate cancer theranostics, including not just the VISION trial but subsequent data.
Presented by Michael Morris, MD
In the Prostate Cancer poster session of the ESMO Annual Congress, Dr. Morris presented a post-hoc analysis of the VISION trial aimed at assessing earlier maturing time-to-event endpoints.
Presented by Ken Herrmann, MD, MBA
The 2022 EAU annual meeting featured a joint session of the EAU, EANM, ESMO, and ESTRO societies examining modern diagnostic and therapeutic approaches in prostate cancer, including a presentation by Dr. Ken Herrmann discussing future perspectives for possible synergies between radioligand and systemic treatment in M1 prostate cancer. Dr. Herrmann notes that synergism of treatment is the holy grail, emphasizing that in the VISION trial 46.0% of patients
Presented by Scott T. Tagawa, MD
At the 2022 ASCO Annual Meeting, the poster session focused on Prostate, Testicular, and Penile cancers on Monday afternoon included a presentation from Dr. Scott T. Tagawa discussing the tolerability of theranostic treatment with 177Lu-PSMA among men with metastatic castration-resistant prostate cancer (mCRPC), stratified by their treatment exposure, in men treated within the VISION trial.
Presented by Masatoshi Hotta, MD, PhD
At the 2022 ASCO Annual Meeting, the poster session focused on Prostate, Testicular, and Penile cancers and included a presentation from Dr. Masatoshi Hotta discussing outcomes of theranostic treatment with 177Lu-PSMA, among patients who would be deemed ineligible for therapy according to criteria used for inclusion in the VISION trial.
Presented by Nitin Vaishampayan, MD, BA
At the 2022 ASCO Annual Meeting, the oral abstract session focused on Prostate, Testicular, and Penile cancers on Sunday morning included a presentation from Dr. Nitin Vaishampayan discussing subgroup analyses of the VISION trial examining 177Lu-PSMA-617 in men with heavily pre-treated metastatic castration-resistant prostate cancer (mCRPC).
Presented by Andrew J. Armstrong, MD, MSc
At the 2022 ASCO Annual Meeting,  the oral abstract session focused on Prostate, Testicular, and Penile cancers on Sunday morning included a presentation from Dr. Andrew J. Armstrong discussing the prognostic value of baseline [68Ga]Ga-PSMA-11 PET imaging in men undergoing theranostic treatment with 177Lu-PSMA-617 for heavily pre-treated metastatic castration-resistant prostate cancer (mCRPC) in the VISION trial.
Presented by Matthew Smith, MD, PhD
In the session of the 2022 Advanced Prostate Cancer Consensus Conference focusing on the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), Dr. Matthew Smith discussed the role of prostate specific membrane antigen (PSMA)-lutetium radionuclide therapy, including considerations regarding monotherapy, combination therapy, and patient selection.
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 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 Ana Kiess, MD, PhD
The 2021 ASTRO Annual Meeting included a joint ASTRO/SNMMI session on prostate cancer molecular imaging and radiotheranostics and a presentation by Dr. Ana Kiess discussing the current and future management paradigms 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 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 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 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.