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Recruiting Phase 3

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

NCT07611110 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2026-05-04
Last updated
2026-08-26

Condition(s) studied

Metastatic Castration-resistant Prostate Cancer

Investigational drug(s) / intervention(s)

Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]) →Cabazitaxel →Abiraterone →Enzalutamide →Apalutamide →Darolutamide →DeutenzalutamideRadium-223 →

Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]): IV

Cabazitaxel: IV in combination with oral prednisone/prednisolone

Abiraterone: Oral in combination with prednisone/prednisolone

Enzalutamide: Oral

Apalutamide: Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)

Darolutamide: Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)

Deutenzalutamide: Oral; available in China only

Radium-223: IV

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (132)

FacilityCityRegionStatus
Research Site Dothan Alabama Recruiting
Research Site Phoenix Arizona Not Yet Recruiting
Research Site Duarte California Not Yet Recruiting
Research Site Irvine California Not Yet Recruiting
Research Site Newport Beach California Recruiting
Research Site San Francisco California Not Yet Recruiting
Research Site Aurora Colorado Not Yet Recruiting
Research Site Miami Florida Recruiting
Research Site O'Fallon Illinois Not Yet Recruiting
Research Site Metairie Louisiana Recruiting
Research Site Detroit Michigan Withdrawn
Research Site Grand Rapids Michigan Not Yet Recruiting
Research Site St Louis Missouri Not Yet Recruiting
Research Site Omaha Nebraska Recruiting
Research Site Albuquerque New Mexico Not Yet Recruiting
Research Site New Hyde Park New York Not Yet Recruiting
Research Site New York New York Not Yet Recruiting
Research Site Cleveland Ohio Not Yet Recruiting
Research Site Dayton Ohio Not Yet Recruiting
Research Site Portland Oregon Not Yet Recruiting
Research Site Pittsburgh Pennsylvania Not Yet Recruiting
Research Site Myrtle Beach South Carolina Not Yet Recruiting
Research Site Nashville Tennessee Not Yet Recruiting
Research Site Houston Texas Recruiting
Research Site Salt Lake City Utah Not Yet Recruiting
Research Site Tacoma Washington Not Yet Recruiting
Research Site Darlinghurst Australia Not Yet Recruiting
Research Site Kurralta Park Australia Not Yet Recruiting
Research Site Melbourne Australia Not Yet Recruiting
Research Site Murdoch Australia Not Yet Recruiting
Research Site Linz Austria Not Yet Recruiting
Research Site Salzburg Austria Not Yet Recruiting
Research Site São Paulo Brazil Not Yet Recruiting
Research Site São Paulo Brazil Not Yet Recruiting
Research Site Edmonton Alberta Not Yet Recruiting
Research Site Halifax Nova Scotia Not Yet Recruiting
Research Site Hamilton Ontario Not Yet Recruiting
Research Site Toronto Ontario Not Yet Recruiting
Research Site Toronto Ontario Not Yet Recruiting
Research Site Montreal Quebec Not Yet Recruiting

+ 92 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07611110 on ClinicalTrials.gov ↗ ← All trials in France