NCT07611110Recruiting
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
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.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Australia, Belgium, Brazil, Canada, China, Finland, India, Israel, Japan, Netherlands, Poland, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
- Sponsor
- AstraZeneca(Industry)
- Protocol no.
- D9735C00001
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Drug
Treatments studied
- Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])
- Cabazitaxel
- Abiraterone
- Enzalutamide
- Apalutamide
- Darolutamide
- Deutenzalutamide
- Radium-223
Locations · 19
- Dothan, United StatesResearch SiteRecruiting at this site
- Duarte, United StatesResearch SiteRecruiting at this site
- Newport Beach, United StatesResearch SiteRecruiting at this site
- San Francisco, United StatesResearch SiteRecruiting at this site
- Miami, United StatesResearch SiteRecruiting at this site
- Metairie, United StatesResearch SiteRecruiting at this site
- Omaha, United StatesResearch SiteRecruiting at this site
- New York, United StatesResearch SiteRecruiting at this site
- Pittsburgh, United StatesResearch SiteRecruiting at this site
- Myrtle Beach, United StatesResearch SiteRecruiting at this site
- Nashville, United StatesResearch SiteRecruiting at this site
- Houston, United StatesResearch SiteRecruiting at this site
- Melbourne, AustraliaResearch SiteRecruiting at this site
- Toronto, CanadaResearch SiteRecruiting at this site
- Montreal, CanadaResearch SiteRecruiting at this site
- Montreal, CanadaResearch SiteRecruiting at this site
- Fukuoka, JapanResearch SiteRecruiting at this site
- Kanazawa, JapanResearch SiteRecruiting at this site
- Sapporo, JapanResearch SiteRecruiting at this site
In total, worldwide, 19 of the 151 sites listed in the registry are recruiting; the other 132 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 19, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.