AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (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)
AstraZeneca
670 participants
May 4, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria12
- ≥ 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 Criteria7
- 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.
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Interventions
IV
IV in combination with oral prednisone/prednisolone
Oral in combination with prednisone/prednisolone
Oral
Oral
Oral
Oral
IV
Locations(90)
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NCT07611110