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PSMAfore: 177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive mCRPC

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
Videos

PSMAfore in taxane-naïve mCRPC Videos

PSMA-RLT Patient Selection & Practice Videos

Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Ken Herrmann, MD
The 2025 ESMO annual meeting featured a prostate cancer session and a presentation by Dr. Ken Herrmann discussing the association between quantitative baseline 68Ga-PSMA-11 PET parameters and 177Lu-PSMA-617 efficacy in the PSMAfore study. In the phase 3 VISION study,1 baseline quantitative PET parameters were associated with efficacy outcomes. Specifically, whole-body SUVmean was the best predictor of 177Lu-PSMA-617 efficacy. In the phase 3 PSMAfore study,
Presented by Neal Shore, MD, FACS
The 2025 AUA annual meeting featured an advanced prostate cancer session and a presentation by Dr. Neal Shore discussing health-related quality of life, pain and safety outcomes in the phase 3 PSMAfore study of 177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer (mCRPC).
 The 2025 PSMA and Beyond annual meeting featured a LuPSMA therapy session and a presentation by Dr. Emmanuel Antonarakis discussing the pre-chemotherapy trials, PSMAfore, SPLASH, and ECLIPSE. Dr. Antonarakis started his presentation highlighting that based on the 2025 NCCN guidelines, the treatment of mCRPC has become quite busy:
Presented by Johann De Bono, MD, MSc, PhD, FRCP, FMedSci
The 2025 GU ASCO annual meeting featured a prostate cancer session and a presentation by Dr. Johann De Bono discussing the association of baseline and on-treatment ctDNA fraction with clinical outcomes in patients with mCRPC in the PSMAfore study of 177Lu-PSMA-617. In PSMAfore,1177Lu-PSMA-617 prolonged radiographic progression free survival versus androgen receptor pathway inhibitor change in taxane-naive adults with PSMA-positive mCRPC progressing once on an androgen receptor pathway inhibitor.
Presented by Kim N. Chi, MD
The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain was host to the presentation of poster 1611. Dr. Kim Chi discussed the hematologic impact of [177Lu]Lu-PSMA-617 versus androgen receptor pathway inhibitor (ARPI) change in patients with metastatic castration-resistant prostate cancer (mCRPC) in the PSMAfore trial.
Presented by Karim Fizazi, MD, PhD
The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 17th was host to the session Poster 1599 presentation. Dr. Karim Fizazi presented the third interim analysis of PSMAfore exploring symptomatic skeletal events, health-related quality of life, and pain in taxane-naive patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
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 Johann S. De Bono, MD, MSc, PhD, FRCP, FMedSci
The 2024 ASCO annual meeting featured a session on prostate cancer, and a presentation by Dr. Johann De Bono discussing baseline ctDNA analyses and associations with outcomes in taxane-naive patients with metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA-617 versus change of androgen receptor pathway inhibitor in PSMAfore.
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 Xiao Wei, MD, MAS
The 2024 AUA annual meeting featured a plenary session, and a presentation by Dr. Xiao Wei discussing results from PSMAfore assessing the efficacy of 177Lu-PSMA-617 versus ARPI change in taxane naïve patients with metastatic castration resistant prostate cancer (mCRPC) stratified by pre-randomization ARPI.
Presented by Christopher Sweeney, MBBS
The 2023 ESMO annual meeting included a Presidential session, featuring a discussant presentation by Dr. Christopher Sweeney discussing the PSMAfore phase 3 trial. Dr. Sweeney started by highlighting that there are several clear strengths of the PSMAfore trial
Presented by A. Oliver Sartor, MD
The 2023 ESMO annual meeting included a Presidential session, featuring a presentation by Dr. Oliver Sartor discussing results of PSMAfore, a phase 3 trial of 177Lu-PSMA-617 in taxane-naive patients with metastatic castration-resistant prostate cancer (mCRPC).
Presented by Thomas Boike, MD, MMM, Oncologist
(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL was host to the International Prostate Forum, with Dr. Thomas Boike discussing the urologist’s role in the field of theranostics.
Presented by Professor Silke Gillessen Sommer, MD
(UroToday.com) The 2023 European Association of Urology (EAU) annual congress held in Milan, Italy between March 10th and 13th, 2023 was host to an EAU Section of Oncologic Urology (ESOU) session addressing progress and controversies in urologic oncology. In her presentation, Professor Silkem Gillessen Sommer discussed the current and future role of PSMA-based theranostics in men with advanced prostate cancer.
Presented by A. Oliver Sartor, MD
A. Oliver Sartor presented the rationale and design of the PSMAfore trial. PSMAfore is a multicenter, open-label, randomized phase 3 trial in adult men with progressive mCRPC and confirmed PSMA expression by [68Ga]Ga-PSMA-11 PET/CT. Eligible patients must be taxane-naïve in the metastatic setting and have received one prior ARPI and be a candidate for a change in ARPI.
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 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 European Commission 'Europe's Beating Cancer Plan'
Novartis will present new data from its robust portfolio and pipeline of advanced therapeutic platforms in solid tumors, with more than 55 abstracts from Novartis-sponsored and investigator-initiated trials accepted at the upcoming European Society for Medical Oncology (ESMO) Congress 2021. The ESMO Congress will be held virtually September 16-21, 2021.
Publications
Articles and Abstracts

In PSMAfore, [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolonged radiographic progression-free survival (rPFS) in taxane-naive patients with metastatic castration-resistant prostate cancer (mCRPC), with a favourable safety profile, versus a change in androgen receptor pathway inhibitor (ARPI).

In the PSMAfore study, lutetium-177 [177Lu]Lu-PSMA-617 (vipivotide tetraxetan) significantly improved radiographic progression-free survival compared with change of androgen receptor pathway inhibitor (ARPI) in taxane-naive patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer.

[177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolongs radiographic progression-free survival and overall survival in patients with metastatic castration-resistant prostate cancer previously treated with androgen receptor pathway inhibitor (ARPI) and taxane therapy.

Reno, Nevada (UroToday.com) -- Novartis announced the pivotal Phase III PSMAfore study with PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan), a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, met its primary endpoint.
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.
San Francisco, CA (UroToday.com) -- Novartis announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to 177Lu-PSMA-617, an investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC).  Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the potential for substantial improvement over available therapy.1