Study Title

novartis

A Phase II, Open-label, Multi-Center, Randomized Study Comparing the Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC)

Study Details

Description:

The purpose of this study is to assess whether the combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI improves radiographic progression-free survival (rPFS) or time to death compared to AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the castrate resistant prostate cancer (CRPC) setting.

Sponsor:

Novartis

Contacts:

Novartis Pharmaceuticals

novartis.email@novartis.com

1-888-669-6682

Drug Details

lutetium Lu 177 vipivotide tetraxetan
Isotope(s):
    LUTETIUM-177
    Radioisotope: Lu-177
    Theranostic Role: Therapeutic Agent & SPECT Imaging
    T1/2 (Half-Life): 6.7 Days
    Decay Mode: BETA, GAMMA
    Energy: Eβeta max 497 keV, Gamma 113-208 keV
    Range: In Tissue: 0.25-2mm
    Decay Daughters: Hf177
    Status: FDA Approvals: PLUVICTO® (2022), LUTATHERA® (2017)
  • LUTETIUM-177
Target(s):
  • PSMA
Ligand: Small Molecules
Chelator: DOTA

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