Trial intelligence / Profile preview

[177Lu]Lu-PSMA-617 vs ARDT in Taxane-Naive Chinese Men with mCRPC

NCT05658003Phase 2

Key facts

Status: Active, not recruiting
Start: May 2023
Primary completion: Dec 2024
Countries: 1
Sponsor: Novartis
Modality: Small Molecules, Peptide-Drug Conjugates

Drugs: lutetium lu 177 vipivotide tetraxetan
Conditions: metastatic castration-resistant prostate cancer (mCRPC)

Overview

Phase 2, randomised, open-label trial of lutetium lu 177 vipivotide tetraxetan in metastatic castration-resistant prostate cancer (mCRPC) (2 arms), sponsored by Novartis. Primary endpoint: Radiographic progression free survival up to 47 months. Started May 2023; status: active, not recruiting.

Design

2 arms

Study design: RandomizedOpen-label

[177Lu]Lu-PSMA-617
Participants receive [177Lu]Lu-PSMA-617 every 6 weeks for 6 cycles.
Androgen receptor-directed therapy (ARDT)
Participants receive a change of ARDT treatment.

Who it enrols

Chinese adult men with progressive mCRPC, ECOG 0-1, who are [68Ga]Ga-PSMA-11 PET/CT positive, have castrate levels of testosterone, and have progressed only once on a prior second-generation ARDT. Must be taxane-naive for prostate cancer and candidates for a change in ARDT.

Endpoints

Primary

Radiographic progression free survivalup to 47 months

Secondary

Overall survivalup to 47 months
Progression Free Survivalup to 47 months
Prostate-specific antigen 50 response rateWeek 48
Time to a first symptomatic skeletal eventup to 47 months
Time to Prostate Specific Antigen progressionup to 47 months
Time to chemotherapyup to 47 months
Overall response rateup to 47 months
Disease control rateup to 47 months

Beyond the preview

Go deeper on NCT05658003.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05658003.