NCT07611110 · AstraZeneca
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
(VECTRA-01)
What this study is about
The intention of the study is to demonstrate superiority of AZD2265 relative to the usual treatment treatments by assessment of radiographic time without the disease getting worse (rPFS) and how long patients live (OS) in participants with mCRPC.
View original scientific description
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.
Interventions
DRUG
Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])
IV
DRUG
Cabazitaxel
IV in combination with oral prednisone/prednisolone
DRUG
Abiraterone
Oral in combination with prednisone/prednisolone
DRUG
Enzalutamide
Oral
DRUG
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)
DRUG
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)
DRUG
Deutenzalutamide
Oral; available in China only
DRUG
Radium-223
IV
Primary outcome measures
Radiographic Progression-Free Survival (rPFS)
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Dothan, Alabama
- Phoenix, Arizona
- Duarte, California
- Irvine, California
- Newport Beach, California
- San Francisco, California
- Aurora, Colorado
- Miami, Florida
- O'Fallon, Illinois
- Metairie, Louisiana
- Detroit, Michigan
- Grand Rapids, Michigan
And 14 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2026 · Source of record for eligibility and locations