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Clinical trial · no report yet · Phase 3

PSMAddition

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

  • NCT04720157 ↗
  • Active not recruiting
  • Novartis Pharmaceuticals
  • 299 commentary sources found
  • Deep

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
X threads139
YouTube85
Podcasts68
X videos7

The trial

ClinicalTrials.gov
Official title
An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Phase
Phase 3
Status
Active not recruiting
Conditions
Prostatic Neoplasms
Interventions
177Lu-PSMA-617; 68Ga-PSMA-11; ARDT; ADT
Arms
  • 177Lu-PSMA-617 · Experimental
  • Standard of Care · Active comparator
Enrollment
1,140
Primary outcomes
  • Radiographic Progression Free Survival (rPFS)
Sponsor
Novartis Pharmaceuticals with Alliance Foundation Trials, LLC., RTOG Foundation, Inc.
Start
Jun 9, 2021
Primary completion
Jan 13, 2025
Results posted
No
Registry record
NCT04720157 · updated Jun 8, 2026

Publications

linked from the registry
  • Tagawa ST, Sartor O, Piulats JM, Saad F, Fizazi K, Reid A, Beltran H, Kramer G, Mahammedi H, Eiber M, Gupta S, Castellano D, Hauke R, Kim H, Kwak C, Pang ST, Barthelemy P, Dai D, Lee JL, Nordquist L, Szmulewitz RZ, Wiechno P, Yovine A, Smith L, Bouillaud E, Sakharova O, Morris MJ; PSMAddition Investigators. [177Lu]Lu-PSMA-617 in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (PSMAddition): a phase 3 randomised, controlled trial. Lancet. 2026 Aug 6:S0140-6736(26)01092-5. doi: 10.1016/S0140-6736(26)01092-5. Online ahead of print. PubMed 42561994