OncRef

Clinical Trial: NCT04720157

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)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Novartis Pharmaceuticals
Information Provided By:Novartis
Last Update Posted:2026-06-08

Study Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care (SOC), versus Standard of Care alone, in adult male patients with Metastatic hormone sensitive prostate cancer (mHSPC). In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study. As of 31-Jan-2024, 1144 participants were enrolled in 20 countries.

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)

Conditions

Prostatic Neoplasms

Intervention / Treatment

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

Other Study ID Numbers

  • CAAA617C12301
  • 2023-507970-42-00
  • 2023

Start Date (Actual)

2021-06-09

Primary Completion Date (Actual)

2025-01-13

Study Completion Date (Estimated)

2027-02-11

Enrollment (Actual)

1140

Study Type

Interventional

Phase

Phase 3