Tests AZD2265 against standard treatments in men with spread prostate cancer
Tests AZD2265 against standard treatments in men with spread prostate cancer.
Plain-language title generated from the registry record
Registry title: AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
Key facts
- Where
- Bern, Geneva, and Zurich, SwitzerlandSee the 3 sites
- Phase
- Phase 3
Where in Switzerland
- BernBern, SwitzerlandNot yet recruiting
- GenevaGeneva, SwitzerlandNot yet recruiting
- ZurichZurich, SwitzerlandNot yet recruiting
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?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07611110
- Record updated
- 19 October 2026
- Original 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.Read full original descriptionShow less
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)
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.
Inclusion: ≥ 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: 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.