AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
VECTRA-01
A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
1 other identifier
interventional
670
15 countries
88
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2026
Typical duration for phase_3
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2026
CompletedStudy Start
First participant enrolled
May 4, 2026
CompletedFirst Posted
Study publicly available on registry
May 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 20, 2029
May 28, 2026
May 1, 2026
2.8 years
April 22, 2026
May 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Radiographic Progression-Free Survival (rPFS)
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.
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)
Overall Survival (OS)
OS is defined as the length of time from randomisation until the date of death due to any cause.
From randomization until death from any cause (up to approximately 33 months)
Secondary Outcomes (7)
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)
Objective Response Rate (ORR)
From baseline; assessed by BICR per RECIST 1.1/PCWG3 every 8 weeks for first 32 weeks, then every 12 weeks until radiographic progression (up to approximately 33 months)
Duration of Response (DoR)
From first documented response until progression per RECIST 1.1/PCWG3 by BICR, or death in the absence of progression, whichever occurs first (up to approximately 33 months)
- +2 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALAZD2265
Arm B
ACTIVE COMPARATORInvestigator's choice of cabazitaxel, ARPI switch, or radium-223
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (90)
Research Site
Dothan, Alabama, 36303, United States
Research Site
Phoenix, Arizona, 85004, United States
Research Site
Irvine, California, 92618, United States
Research Site
Loma Linda, California, 92354, United States
Research Site
San Francisco, California, 94143, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Miami, Florida, 33165, United States
Research Site
O'Fallon, Illinois, 62269, United States
Research Site
Metairie, Louisiana, 70006, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site
Grand Rapids, Michigan, 49503, United States
Research Site
Omaha, Nebraska, 68130, United States
Research Site
Omaha, Nebraska, 68130, United States
Research Site
Albuquerque, New Mexico, 87109, United States
Research Site
New Hyde Park, New York, 11042, United States
Research Site
New York, New York, 10065, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Dayton, Ohio, 45415, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Pittsburgh, Pennsylvania, 15232, United States
Research Site
Myrtle Beach, South Carolina, 29572, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Houston, Texas, 77042, United States
Research Site
Salt Lake City, Utah, 84106, United States
Research Site
Darlinghurst, 2010, Australia
Research Site
Melbourne, 3000, Australia
Research Site
Linz, 4020, Austria
Research Site
Salzburg, 5020, Austria
Research Site
São Paulo, 01308-050, Brazil
Research Site
São Paulo, 05652-900, Brazil
Research Site
Edmonton, Alberta, T6G 1Z2, Canada
Research Site
Halifax, Nova Scotia, B3H 1V7, Canada
Research Site
Hamilton, Ontario, L8V 1C3, Canada
Research Site
Toronto, Ontario, M4N 3M5, Canada
Research Site
Montreal, Quebec, H3A 1A1, Canada
Research Site
Montreal, Quebec, H3T 1E2, Canada
Research Site
Beijing, 100034, China
Research Site
Chengdu, 610041, China
Research Site
Chongqing, 400030, China
Research Site
Fuzhou, 350005, China
Research Site
Guangzhou, 510060, China
Research Site
Guangzhou, 510120, China
Research Site
Guangzhou, 510630, China
Research Site
Nanjing, 210006, China
Research Site
Nanjing, 210029, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200032, China
Research Site
Wuhan, 430022, China
Research Site
Wuhan, 430030, China
Research Site
Villejuif, 94800, France
Research Site
Berlin, 13353, Germany
Research Site
Bonn, 53127, Germany
Research Site
Dresden, 01307, Germany
Research Site
Essen, 45122, Germany
Research Site
Karlsruhe, 76133, Germany
Research Site
Münster, 48149, Germany
Research Site
Rostock, 18057, Germany
Research Site
Tübingen, 72076, Germany
Research Site
Würzburg, 97080, Germany
Research Site
Bangalore, 560017, India
Research Site
Gurgaon, 122001, India
Research Site
Gurgaon, 122002, India
Research Site
Navi Mumbai, 410210, India
Research Site
Fukuoka, 812-8582, Japan
Research Site
Kanazawa, 920-8641, Japan
Research Site
Kashiwa, 227-8577, Japan
Research Site
Sapporo, 060-8638, Japan
Research Site
Goyang-si, 10408, South Korea
Research Site
Seoul, 3722, South Korea
Research Site
Seoul, 5505, South Korea
Research Site
Barcelona, 08025, Spain
Research Site
Barcelona, 8035, Spain
Research Site
L'Hospitalet de Llobregat, 08908, Spain
Research Site
Madrid, 28041, Spain
Research Site
Málaga, 29009, Spain
Research Site
Santiago de Compostela, 15706, Spain
Research Site
Kaohsiung City, 833401, Taiwan
Research Site
Taipei, 10002, Taiwan
Research Site
Taipei, 11217, Taiwan
Research Site
Taipei, 11259, Taiwan
Research Site
Taoyuan, 333, Taiwan
Research Site
Bangkok, 10210, Thailand
Research Site
Bangkok, 10700, Thailand
Research Site
Ankara, 06530, Turkey (Türkiye)
Research Site
Ankara, 06620, Turkey (Türkiye)
Research Site
Istanbul, 34098, Turkey (Türkiye)
Research Site
Istanbul, 34752, Turkey (Türkiye)
Research Site
London, EC1A 7BE, United Kingdom
Research Site
Middlesbrough, TS4 3BW, United Kingdom
Research Site
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Open-label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2026
First Posted
May 28, 2026
Study Start
May 4, 2026
Primary Completion (Estimated)
February 13, 2029
Study Completion (Estimated)
December 20, 2029
Last Updated
May 28, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.