At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]) (drug), Cabazitaxel (drug), Abiraterone (drug), Enzalutamide (drug)
- How long the study runs
- Study runs about 49 months (dates as stated)
- About the drug or intervention
- Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]) — drug: IV · Cabazitaxel — drug: IV in combination with oral prednisone/prednisolone · Abiraterone — drug: Oral in combination with prednisone/prednisolone · Enzalutamide — drug: Oral · Apalutamide — drug: 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 — drug: 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 — drug: Oral; available in China only · Radium-223 — drug: IV
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called VECTRA-01, tests a new medicine called AZD2265 against standard care in men with metastatic castration-resistant prostate cancer (prostate cancer that has spread and no longer responds to hormone treatment). It is run by AstraZeneca. The cancer must show a marker called PSMA on scans.
Who can take part
- Men aged 18 or over with adenocarcinoma of the prostate (a common type of prostate cancer)
- Cancer that has spread (metastatic) and is getting worse despite hormone treatment or surgery to lower testosterone
- Already treated with at least 2 cycles of a PSMA-targeted radioactive drug, at least 1 taxane chemotherapy, and at least 1 hormone-style tablet such as enzalutamide or abiraterone
- A positive PSMA PET/CT scan using specified PSMA tracers
- Able to carry out light activity or more (performance status 0 to 2)
- Good enough organ and bone marrow function as set out in the study protocol
- Agreement not to father children or donate sperm, and to use condoms, during the study and for 6 months after the last dose
Who may not be able to
- Previous treatment with an alpha-emitting radioactive drug that targets cancer cells (radium-223 is allowed)
- Cancer getting worse on a PSMA-targeted radioactive drug before cycle 3
- More than 6 cycles of a PSMA-targeted radioactive drug
- Another primary cancer in the past, with some exceptions
- Ongoing moderate or worse side effects from earlier cancer treatment, with some exceptions
- Spinal cord compression or cancer spread to the brain, unless there are no symptoms, it is stable, and no steroids have been needed for at least 4 weeks before starting
- Significant abnormalities on heart tracing (ECG), with some exceptions
What taking part involves
- • Taking the study drug AZD2265 or receiving standard care — how it is given is not stated, ask the trial team
- • Regular scans (CT, MRI or bone scan) to check the cancer
- • PSMA PET/CT scanning
Time commitment: Not stated — ask the trial team about number of visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 670
- Started
- 2026-05-04
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic castration-resistant prostate cancer
- • Phase3 - 670 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic castration-resistant prostate cancer
- • Male only
Where?
- • London - Research Site
- • Middlesbrough - Research Site
- • Southampton - Research Site
- • Truro - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Approximately 670 adult participants with mCRPC will be randomized to receive either AZD2265 or standard of care treatment (investigator's choice of cabazitaxel, ARPI, or radium-223). They will receive their assigned treatment until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Tumor evaluation scans will continue after treatment discontinuation until radiographically confirmed progression or death. All patients will be followed for survival until the end of the study. An Independent Data Monitoring Committee (IDMC) composed of independent experts will be convened to monitor the safety and scientific integrity of the study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
- How fit you need to be: ECOG 0 or better
Treatment history
Treatments you must have had:
- ✓ had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone
What the study is looking for
- ✓≥ 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.
- ✓Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.
- ✓Previously treated with at least 1 taxane-based drug treatment regimen for either that has spread hormone-sensitive...
Who cannot take part
- ✗Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is...
- ✗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 cancer, with exceptions.
- ✗Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.
See the full criteria
Where Is This Study? (4 UK sites)
Research Site
London EC1A 7BE, United Kingdom
Research Site
Middlesbrough TS4 3BW, United Kingdom
Research Site
Southampton SO16 6YD, United Kingdom
Research Site
Truro TR1 3LJ, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT