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AZD2265

Phase 3

Metastatic Castration-resistant Prostate Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: May 28, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment670
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07611110AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)PHASE3 RECRUITING 670 — — May 4, 2026Dec 20, 2029May 28, 202690 United States, Australia +14
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Study Endpoints
Primary Endpoints
Radiographic Progression-Free Survival (rPFS)
From randomization until first radiographic progression per RECIST 1.1/PCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months)

rPFS is defined as the time from randomisation to radiographic progression, as assessed by the BICR per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause.

Overall Survival (OS)
From randomization until death from any cause (up to approximately 33 months)

OS is defined as the length of time from randomisation until the date of death due to any cause.

Secondary Endpoints
Progression-Free Survival (PFS)
From randomization until first documented progression (radiographic, clinical, or PSA progression) or death in the absence of progression, whichever occurs first (up to approximately 33 months)
Assessment of PSA50 (≥50% prostate-specific antigen reduction)
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Assessment of PSA90 (≥90% prostate-specific antigen reduction)
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTALAZD2265
Arm BACTIVE_COMPARATORInvestigator's choice of cabazitaxel, ARPI switch, or radium-223
Interventions
NameTypeDescription
AZD2265DRUGIV
CabazitaxelDRUGIV in combination with oral prednisone/prednisolone
AbirateroneDRUGOral in combination with prednisone/prednisolone
EnzalutamideDRUGOral
ApalutamideDRUGOral
DarolutamideDRUGOral
RezvilutamideDRUGOral
Radium-223DRUGIV
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites90

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 ...

Countries:United StatesAustraliaAustriaBrazilCanadaChinaFranceGermanyIndiaJapanSouth KoreaSpainTaiwanThailandTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07611110NEW_TRIAL: changed
LOWMay 29, 2026NCT07611110NEW_TRIAL: changed
LOWMay 29, 2026NCT07611110NEW_TRIAL: changed