Taking peoplePhase 3
Tests AZD2265 against standard treatments in men with spread prostate cancer
Tests AZD2265 against standard treatments in men with spread prostate cancer.
Key facts
- Who runs it
- AstraZeneca
- Where
- Ankara and Istanbul, TürkiyeSee the 2 sitesAlso in 23 other countries, 125 sites
- Trial code
- Registry title
- AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 670 people, planned
- Started
- 4 May 2026
- Expected to end
- 6 Jun 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])
- Cabazitaxel
- Abiraterone
- Enzalutamide
- Apalutamide
- Darolutamide
- Deutenzalutamide
- Radium-223
- Record updated
- 19 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread and no longer responds to hormone-lowering treatment. Their PSMA PET/CT scans must be positive, and they must have had several earlier treatments.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Metastatic castration-resistant prostate cancer that is getting worse after the latest treatment, with at least 1 spread lesion that can be followed by scan. ECOG performance status 0 to 2.
- Earlier treatment
- Must have had at least 2 cycles of a PSMA-directed β-emitting radioconjugate (but not more than 6), at least 1 taxane-based chemotherapy, and at least 1 ARPI (for example enzalutamide, abiraterone). Must have had orchiectomy and/or ongoing ADT with castrate-level testosterone.
- Biomarker or test result
- Positive PSMA PET/CT scan, done with ⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL
Main reasons for not taking part
- Earlier treatment with an α-emitting targeted radioconjugate (radium-223 is allowed)
- Disease progressed on the PSMA-directed β-emitting radioconjugate before cycle 3
- More than 6 cycles of PSMA-directed β-emitting radioconjugate
- Another primary cancer in the past, with some exceptions
- Spinal cord compression or brain metastases, unless symptom-free, stable and off steroids for at least 4 weeks
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- ≥ 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
Who cannot take part
- 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
- 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
- History of another primary malignancy, with exceptions
- Receipt of > 6 cycles of PSMA-directed β-emitting therapeutic RC
- Clinically significant ECG abnormalities, with exceptions
Where in Türkiye
Also in 23 other countries, 125 sites
- AnkaraHospital not named in the registryNot yet recruiting
- IstanbulHospital not named in the registryNot yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Arm ATreatment being tested
Actinium (225Ac) zadavotide guraxetan (AZD2265 \[FPI-2265\])
Treatment: Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])
- Arm BExisting treatment, for comparison
Investigator's choice of cabazitaxel, ARPI, or radium-223
Treatment: Cabazitaxel, Abiraterone, Enzalutamide, Apalutamide, Darolutamide, Deutenzalutamide, and Radium-223
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Tests AZD2265 against standard treatments in men with spread prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 October 2026