Clinical Trial · NCT04689828

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

Overview

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.

Sponsor

Novartis

Phase

Phase 3

Contacts

Novartis Pharmaceuticals (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT04689828

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Participants must have \>= 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained prior to randomization.
Participants must have an ECOG performance status of 0 to 1.
Participants must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
Second generation ARDT must be the most recent therapy received.
Participants must be 68Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader.
Participants must have histological pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
Platelets \>= 100 x 109/L

Exclusion

Previous PSMA-targeted radioligand therapy.
Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids. Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired.