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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07611110

The VECTRA-01 trial involves 670 mCRPC patients randomized to receive AZD2265 or standard treatments like cabazitaxel, ARPI switch, or radium-223. Eligibility includes prior treatments and PSMA-positive scans. The study assesses rPFS and OS, with safety monitored by an IDMC. Participants must adhere to specific reproductive precautions during and post-study.

Patient Parameters

Program Overview

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.

Description

Approximately 670 adult participants with mCRPC will be randomized to receive either AZD2265 or standard of care treatment (investigator's choice of cabazitaxel, ARPI switch, or radium-223). They will receive their assigned treatment until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Tumor evaluation scans will continue after treatment discontinuation until radiographically confirmed progression or death.

All patients will be followed for survival until the end of the study. An Independent Data Monitoring Committee (IDMC) composed of independent experts will be convened to monitor the safety and scientific integrity of the study.

Eligibility Criteria

Inclusion Criteria

  • ≥ 18 years of age.
  • Diagnosis of adenocarcinoma of prostate.
  • Must have had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone.
  • 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.
  • Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.
  • Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC.
  • Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.).
  • Positive PSMA PET/CT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL).
  • ECOG performance status of 0 to 2.
  • Adequate organ and bone marrow function as described in study protocol.
  • Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
  • Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.

Exclusion Criteria

  • Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).
  • Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.
  • Receipt of > 6 cycles of PSMA-directed β-emitting therapeutic RC.
  • History of another primary malignancy, with exceptions.
  • Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.
  • Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
  • Clinically significant ECG abnormalities, with exceptions.

Locations

FACILITYZIPCITYSTATE
Research Site36303DothanAlabama
Research Site85004PhoenixArizona
Research Site92618IrvineCalifornia
Research Site92354Loma LindaCalifornia
Research Site94143San FranciscoCalifornia
Research Site80045AuroraColorado
Research Site33165MiamiFlorida
Research Site62269O'FallonIllinois
Research Site70006MetairieLouisiana
Research Site48201DetroitMichigan

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