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PSMAddition: Phase 3 Trial of [177lu]Lu-PSMA-617 Plus Standard of Care (SoC) vs. Soc Alone in Patients with Metastatic Hormone-Sensitive Prostate Cancer

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
Videos
Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Fred Saad, CQ, MD, FRCS, FCAHS
Fred Saad, CQ, MD, FRCS, FCAHS, presented the results of subgroup analyses by disease volume and timing (de novo versus recurrent) from the PSMAddition study of [177Lu]Lu-PSMA-617] in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.
Presented by Fred Saad, MD, FRCSC
The 2026 American Urological Association (AUA) Annual Meeting featured a podium presentation by Dr. Fred Saad reporting prostate-specific antigen (PSA) endpoints from the phase 3 PSMAddition trial evaluating Lutetium Lu 177 vipivotide tetraxetan ([177Lu]Lu-PSMA-617) in combination with androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC).
Presented by Oliver Sartor, MD
The 2026 PSMA & Beyond conference featured a clinical trial updates session and presentation by Dr. Oliver Sartor discussing the PSMAddition trial, which randomized men with untreated or minimally treated mHSPC and ≥1 PSMA-positive metastatic lesion on 68Ga-PSMA-11 PET/CT to the experimental arm of 177Lu-PSMA 617 (7.4 GBq ±10% 6 cycles every 6 weeks) + ADT + androgen receptor pathway inhibitor versus the control arm of ADT + androgen receptor pathway inhibitor. 
Presented by Michael Morris, MD
Dr. Michael Morris discussed health-related quality of life, pain, and symptomatic skeletal events in the phase 3 PSMAddition study of 177Lu-PSMA-617 combined with ADT and androgen receptor pathway inhibitor in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC).
Presented by Scott T. Tagawa, MD, MS, FACP, FASCO
The 2025 SUO annual meeting featured a prostate cancer session and a late breaking abstract presentation by Dr. Scott Tagawa discussing top line results from PSMAddition, a Phase 3 Trial of ADT and ARPI +/- 177Lu-PSMA-617 in Patients with PSMA-Positive Metastatic Hormone Sensitive Prostate Cancer.
Presented by Arun Azad, PhD, MBBS, FRACP
Dr. Arun Azad discussed PSMAddition, a phase III trial of [177Lu]Lu-PSMA-617 combined with androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI) in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC).
Presented by  Scott T. Tagawa, MD, MS, FACP, FASCO
The 2025 European Society for Medical Oncology (ESMO) Annual Congress, held in Berlin, Germany, between October 17th and 21st, 2025, was host to a presidential symposium. Dr. Scott Tagawa presented PSMAddition, a phase III trial of [177Lu]Lu-PSMA-617 combined with androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI) in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC).
Presented by Scott T. Tagawa, M.D., MS, FACP
The 2023 ASCO annual meeting included a prostate cancer session, featuring a trials in progress presentation by Dr. Scott Tagawa discussing PSMAddition, a phase 3 trial comparing 177Lu-PSMA-617 + standard of care and standard of care alone in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Presented by A. Oliver Sartor, MD
A. Oliver Sartor presented the rationale and design of the PSMAddition trial. The PSMAddition trial is an international, prospective, open-label, randomized, phase 3 trial in adults with mHSPC.
Presented by Scott T. Tagawa 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. This therapy depends on prostate cancer cell surface expression of PSMA, which may be altered by androgen pathway inhibitors. To optimize the utility of this treatment modality in metastatic hormone-sensitive prostate cancer (mHSPC), the PSMAddition trial (NCT04720157) was designed.
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.
Publications
Articles and Abstracts

The upfront treatment of metastatic prostate cancer consists of androgen deprivation therapy (ADT) with an androgen receptor pathway inhibitor (ARPI), with or without the addition of docetaxel or a poly(ADP-ribose) polymerase (PARP) inhibitor.

Press Releases
Official Announcements on Clinical Developments
Las Vegas, Nevada (UroToday.com) -- Novartis announced new data from PSMAddition demonstrating improved prostate-specific antigen (PSA) responses with Pluvicto® (lutetium (177Lu) vipivotide tetraxetan) combined with standard of care (SoC) in PSMA-positive metastatic hormone sensitive prostate cancer (mHSPC). Data were presented as a rapid oral presentation at the American Urological Association Annual Meeting 2026.
Reno, Nevada (UroToday.com) -- Novartis presents new Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan) data from the Phase III PSMAddition trial in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2025.