AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

Description:

The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic progression-free survival (rPFS) and overall survival (OS) in participants with mCRPC.

Sponsor:

AstraZeneca

Phase:

Phase 3

Contacts:

AstraZeneca Clinical Study Information Center (CONTACT)

information.center@astrazeneca.com

1-877-240-9479

AZD2265

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Inclusion
  • Diagnosis of adenocarcinoma of prostate.
  • Must have had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone.
  • Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.
  • Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and/or non-measurable) that is suitable for repeated assessment by CT and/or MRI and/or bone scan.
  • * ≥ 18 years of age.
Exclusion
  • * Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).
  • Receipt of \> 6 cycles of PSMA-directed β-emitting therapeutic RC.
  • Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.
  • History of another primary malignancy, with exceptions.
  • Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.