OncRef

Clinical Trial: NCT04689828

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Novartis Pharmaceuticals
Information Provided By:Novartis
Last Update Posted:2026-09-11

Study Overview

Brief Summary

The purpose of this study is to determine whether 177Lu-PSMA-617 improves the Radiographic progression-free survival (rPFS) or Overall Survival (OS) compared to a change in Androgen receptor-directed therapy (ARDT) in metastatic castrate resistant prostate cancer (mCRPC) participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings.

469 participants were randomized (235 in the 177Lu-PSMA-617 group and 234 in the ARDT group.

Official Title

PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-Directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer

Conditions

Prostatic Neoplasms

Intervention / Treatment

  • Drug: 177Lu-PSMA-617
  • Drug: 68Ga-PSMA-11
  • Drug: ARDT

Other Study ID Numbers

  • CAAA617B12302
  • 2023-507772-50-00
  • 2023

Start Date (Actual)

2021-06-15

Primary Completion Date (Actual)

2022-10-02

Study Completion Date (Estimated)

2026-09-10

Enrollment (Actual)

469

Study Type

Interventional

Phase

Phase 3