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ASCO GU 2019: Randomized Phase III Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning

San Francisco, CA (UroToday.com)  Salvage radiotherapy (SRT) for prostate cancer biochemical recurrence after radical prostatectomy (RP) is commonly administered to patients with PSA < 1 ng/mL, a threshold at which standard-of-care imaging is not sensitive enough to detect disease recurrence.  68Ga-PSMA-11 PET/CT (PSMA) PET/CT molecular imaging is highly sensitive for detecting regional and distant metastatic recurrent prostate cancer at low PSA levels. This lead to the assumption that PSMA can help guide and improve SRT.  

A recent multicenter retrospective study in 270 patients with early biochemical recurrence (PSA<1.0 ng/ml), following RP was conducted. The results demonstrated that PSMA PET/CT had a major impact in 19% of patients undergoing SRT by showing lesions outside the standard radiation field. Most frequent localization of out of field lesions was in the bone and the perirectal area. According to Dr. Calais,  this retrospective study justified conducting a randomized phase 3 imaging trial of SRT with or without PSMA PET/CT investigating its potential benefit on clinical outcome.

In this presented randomized phase 3 trial ,presented in a poster format, the defined goal was to evaluate the success rate of SRT for biochemical recurrence following RP with and without planning based on PSMA scan. In this poster, Dr. Calais presented the protocol of this randomized trial. According to the protocol, a total of 193 patients will be randomized to either a control arm (standard SRT, n=90) and an intervention arm (PSMA PET/CT prior SRT planning, n=103). The primary endpoint is the success rate of SRT measured as biochemical progression-free survival. The secondary endpoints include 5-year biochemical progression-free survival from initiation of SRT, metastasis-free survival, initiation of additional salvage therapy after completion of SRT, and change in initial treatment intent. Patients will be followed for five years, and the trial design is shown in figure 1.

Figure 1 – Trial design:
Randomized Phase III Trial of 68GaPSMA11 PETCT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning

The choice of treating the prostate bed with or without treating the pelvic lymph nodes, and with or without androgen deprivation therapy, is left to the discretion of the treating radiation oncologist. According to the trial protocol, the treating radiation oncologist may or may not change the radiotherapy plan depending on the PSMA findings. Any other imaging is allowed for SRT planning if done per routine care.  

Lastly, the main issues and pitfalls of the study include: 
  1. Drop-out of patients randomized to the control arm
  2. Potential FDA approval of PSMA PET imaging probes in the near future (no randomization to standard arm would be then acceptable).  
This is the first prospective randomized phase 3 trial designed to determine whether PET/CT can improve the outcome of SRT in patients with biochemical recurrence, and we eagerly await its results. 

Presented by: Jeremie Calais, MD, MSc, Assistant Professor at the Ahmanson Translational Imaging Division of the Department of Molecular and Medical Pharmacology, UCLA Nuclear Medicine Department, Los Angeles, CA

Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA

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Randomized Prospective Phase III Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT] - Beyond the Abstract
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Conference Highlights Written by Physician-Scientist
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 The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain was host to the session Biochemical failure post-local therapy: An opportunity for tailored treatment? Dr. Daniela E. Oprea-Lager discussed if PSMA PET could be a game changer for treatment decision-making in patients with biochemical failure post-local therapy.
Presented by  Michael S. Hofman, MBBS (Hons), FRACP, FAANMS
The 2024 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Michael Hofman discussing Prostate Cancer Working Group 4 (PCWG4) preliminary criteria using serial PSMA PET/CT for response evaluation.
Presented by Jiarou Wang, MD
At the 2024 SNMMI annual meeting Dr. Jiarou Wang discussed the diagnostic performance of 68Ga-P16-093 in newly diagnosed prostate cancer. 68Ga-P16-093 is a novel PSMA-targeted radiopharmaceutical that has a labeling reaction compatible with various Ge/Ga generators and has a simple labeling method of heating at 95 degrees Celsius for 5 minutes, leading to high radiochemical purity. As a targeting agent in prostate cancer patients,
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(UroToday.com) The 2024 Society of Nuclear Medicine & Molecular Imaging (SNMMI) annual meeting featured a session on prostate cancer, and a presentation by Dr. Luke Nordquist discussing results of COBRA, an assessment of the safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy.
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 Linlin Li, PhD
The 2024 SNMMI annual meeting featured a session on prostate cancer, and a presentation by Dr. Linlin Li discussing the dosimetry and pilot therapy study of novel PSMA-targeting agents, 177Lu-P17-087 and 177Lu-P17-088, in metastatic castration-resistant prostate cancer patients. 
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 Nat Lenzo, MD, EMBA, FRACP, FAANMS, GAICD
At the 2024 SNMMI annual meeting, Dr. Nat Lenzo presented preliminary results of ProstACT SELECT, specifically the safety, tolerability, and dosimetry of TLX591 with best standard of care in patients with PSMA-expressing metastatic castration resistant prostate cancer.
Presented by Michael S. Hofman, MBBS (Hons), FRACP, FAANMS, FICI
The 2024 SNMMI annual meeting featured the Therapy Center of Excellence Saul Hertz Lecture and Award, and a presentation by Dr. Michael Hofman discussing bridging evidence-based medicine and precision oncology. Saul Hertz (1905-1950) conceived and brought from bench to bedside radioactive iodine for medical uses based on the 1936 question “Could iodine be made radioactive artificially?” This was followed by the 1937 radioactive iodine studies assessing thyroid physiology, tracer qualities, dosimetry, and thyroid carcinoma. 
Presented by James Buteau, MD, FRACP, FRCPC
Th SNMMI 2024 Annual Meeting was host to a prostate cancer novel approaches and combination therapies session. Dr. James Buteau discussed novel approaches of combination PSMA-based radiopharmaceutical treatments for prostate cancer.
Presented by David Chen, PhD
At the SNMMI 2024 Annual Meeting, David Chen presented the results of a prospective analysis of the ProsTIC registry evaluating the oncologic and quality-of-life outcomes of metastatic castration-resistant prostate cancer (mCRPC) patients with a stable or poor initial PSA response to [177Lu]Lu-PSMA-617, and the prognostic value of baseline imaging biomarkers and dosimetry.
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 Benjapa Khiewvan, MD
At the SNMMI 2024 Annual Meeting Dr. Benjapa Khiewvan presented the first Thai experience with Lu-177-PSMA-I&T treatment for patients with metastatic castrate-resistant prostate cancer (mCRPC).
Presented by Fuad Novruzov, MD, PhD
At the SNMMI 2024 Annual Meeting Dr. Fuad Novruzov presented the results of a prospective phase 3 randomized study from Azerbaijan evaluating 225Ac-PSMA + 177Lu-PSMA tandem therapy for metastatic castration-resistant prostate cancer (mCRPC).
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 Josef Zahner, PhD
At the SNMMI 2024 Annual Meeting, Dr. Josef Zahner presented the first dosimetry results of a study evaluating the influence of androgen receptor pathway inhibitors (ARPIs) on absorbed doses in metastatic castrate-resistant prostate cancer (mCRPC) patients undergoing 177Lu-PSMA-617 therapy.
Presented by  Michael Gorin, MD
The 2024 ASCO annual meeting was host to a presentation by Dr. Michael Gorin, who presented CLARIFY, a phase III diagnostic study of positron emission tomography (PET) using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy.
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The 2024 European Association of Urology (EAU) annual meeting featured a session on adverse pathology and imaging for risk assessment and local staging, and a presentation by Dr. Rui Bernardino discussing intraductal prostate cancer affinity for lymphatic-predominant metastases through 18F-DCFPyL-PSMA-PET/CT scans in pre-treatment prostate cancer patients.
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The 2024 European Association of Urology (EAU) annual congress held in Paris, France was host to a plenary session addressing imaging-related controversies for the staging of genitourinary cancers. Professor Ken Herrmann discussed the advantages and pitfalls of molecular imaging for prostate cancer characterization.
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The SUO annual meeting included a prostate cancer session and a presentation by Dr. Gerald Andriole discussing the impact of 18F-fluciclovine PET/CT on plans for ADT in patients with biochemical recurrence of prostate cancer. 
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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 Michael S. Hofman, MBBS (Hons), FRACP, FAANMS,
The game changing session of the European Association of Urology (EAU)’s 2021 annual meeting included a presentation by Dr. Michael Hofman from the Peter MacCallum Cancer Centre discussing the phase 2 trial of 177Lu-PSMA-617, TheraP, as well as important contrasts/differences between TheraP and VISION.
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.
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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.
Presented by James Wysock, MD, MSc
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Presented by Matthew R. Cooperberg, MD, MPH and Tanya B. Dorff, MD
To conclude the advances in prostate cancer session Drs. Matthew Cooperberg and Tanya Dorff debated whether prostate-specific membrane antigen (PSMA) imaging should be routinely used in the clinical management of prostate cancer.
Presented by Declan Murphy, MB, BCH, BaO, FRACS, FRCS, Urol
At the 2020 virtual Society of Urologic Oncology's (SUO) prostate cancer session, Dr. Declan Murphy discussed the role of prostate-specific membrane antigen (PSMA) scanning in prostate cancer staging. Dr. Declan Murphy states that PSMA PET/CT is an obvious challenger to conventional imaging.
Presented by Declan Murphy, MB, BCH, BaO, FRACS, FRCS, Urol
(UroToday.com) During the Individualized Approach in Advanced Prostate Cancer session at the European Multidisciplinary Congress on Urological Cancers (EMUC) 2020 virtual meeting, Dr. Declan Murphy presents on using prostate-specific membrane antigen (PSMA) positron emission tomography (PET) for upfront staging in high-risk prostate cancer disease. Dr. Murphy states that PSMA PET/CT is an obvious challenger to conventional imaging.
Presented by Renu Eapen, MD
The Société Internationale d'Urologie (SIU) 2020 Virtual Annual Congress featured a debate discussing imaging definitions for oligometastatic prostate cancer. Dr. Renu Eapen from Australia argued that oligometastatic disease should be defined based on novel imaging modalities.
Presented by Noel William Clarke, MD
The Société Internationale d'Urologie (SIU) 2020 Virtual Annual Congress featured a debate discussing imaging definitions for oligometastatic prostate cancer. Dr. Noel Clarke from the United Kingdom argued that oligometastatic disease should be defined based on standard imaging modalities.
Presented by Michael S. Hofman, MBBS (Hons), FRACP, FAANMS,
(UroToday.com) As part of the “Game-Changing Session 1” plenary presentation at the 2020 European Association of Urology (EAU) Virtual Annual Meeting, Dr. Michael Hofman presented results of the proPSMA study which was recently published in the Lancet.1
Presented by Scott T. Tagawa, MD, MS, FACP
There are currently significant imaging deficiencies for men with prostate cancer (Figure 1), with the hope that PSMA imaging-based modalities will address a significant gap in this field. Prostate-specific membrane antigen PSMA is a transmembrane glycoprotein with folate hydrolase activity.
Presented by Michael J. Morris, MD
Men with biochemically recurrent prostate cancer after definitive local therapy currently have limited imaging modalities in the United States which are sensitive or specific enough to detect tumor recurrence. PSMA PET scans can improve on this detection by detecting cells expressing PSMA protein on their cell surface.
Presented by Charles J. Ryan, MD, & Markus Graefen, MD
San Francisco, California (UroToday.com)  The first case presented was that of a 54-year-old otherwise healthy man who underwent radical prostatectomy after biopsy-confirmed prostate cancer.
Presented by Jeremie Calais, MD
San Francisco, California (UroToday.com) Advanced imaging is increasingly being used across all stages of prostate cancer. Dr. Jeremie Calais from UCLA Medical Center discussed
Presented by Claire M. De La Calle, MD
Washington, DC (UroToday.com) While PSA screening has resulted in decreasing prostate cancer mortality, PSA is also known to be a poorly specific test for the detection of clinically
Presented by Renu Eapen, FRACS
Athens, Greece (UroToday.com) Dr. Renu Eapen gave an overview of the role of PET- prostate-specific membrane antigen (PSMA) in prostate cancer and gave a preview of what is to come
Presented by Sigrid Carlsson, MD, PhD, MPH
Athens, Greece (UroToday.com) Dr. Carlsson gave an encompassing presentation on prostate cancer screening from the perspective of an epidemiologist.
Presented by Cora Sternberg, MD
Barcelona, Spain (UroToday.com)  Dr. Cora Sternberg summarized the findings from several posters, including three immunotherapy phase 1 or 2 trials, a phase 2 trial of 177Lu-PSMA-617,
Presented by Scott T. Tagawa, MD, MS
Barcelona, Spain (UroToday.com) PSMA is overexpressed in prostate cancer with limited expression in other organs. Furthermore, prostate cancer is radiosensitive with dose-response (
Presented by Stefano Fanti, MD
Barcelona, Spain (UroToday.com) Theranostics is an emerging field of medicine which utilizes targeted cancer therapy based on specific molecular-targeted diagnostic tests. As part of the Imaging in Prostate Cancer plenary session at the 2019 European Association of Urology (EAU) annual meeting in Barcelona, Spain
Presented by Olivier Rouvière, MD, PhD
Barcelona, Spain (UroToday.com) Dr. Rouviere presented the imaging specialist’s perspective on MRI use in prostate cancer. According to the European Association of Urology (EAU) guidelines prostate multiparametric MRI (mpMRI) was originally recommended after a negative prostate biopsy
Presented by Michael Hofman, FRACP, MBBS

San Francisco, CA (UroToday.com) PSMA is over-expressed in all prostate tissue, including prostatic carcinoma. Lutetium-177 (177Lu)-PSMA617 (LuPSMA) is a small radiolabeled molecule which binds to PSMA

Presented by Jeremie Calais, MD, MSc
San Francisco, CA (UroToday.com)  Salvage radiotherapy (SRT) for prostate cancer biochemical recurrence after radical prostatectomy (RP) is commonly administered to patients with PSA < 1 ng/mL, a threshold at which standard-of-care imaging 
Presented by Paul L. Nguyen, MD
Prague, Czech Republic (UroToday.com) Dr. Paul Nguyen took the stance for radiation therapy in this much-anticipated debate regarding appropriate local treatment in men with high risk localized prostate cancer. Dr. Nguyen notes that high-quality radiation therapy for high-risk disease needs long-term ADT and a brachytherapy boost.