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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
Milan, Misterbianco, Naples, Negrar, Reggio Emilia, and Rozzano, ItalySee the 6 sitesAlso in 23 other countries, 121 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 Italy

Also in 23 other countries, 121 sites

  • MilanHospital not named in the registryNot yet recruiting
  • MisterbiancoHospital not named in the registryNot yet recruiting
  • NaplesHospital not named in the registryNot yet recruiting
  • NegrarHospital not named in the registryNot yet recruiting
  • Reggio EmiliaHospital not named in the registryNot yet recruiting
  • RozzanoHospital 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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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