NCT07611110 AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
| NCT ID | NCT07611110 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AstraZeneca |
| Condition | Metastatic Castration-resistant Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 670 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2029-06-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 670 participants in total. It began in 2026-05-04 with a primary completion date of 2029-06-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07611110 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Castration-resistant Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07611110 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 670 participants.
Is NCT07611110 currently recruiting?
Yes, NCT07611110 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07611110 trial being conducted?
This trial is being conducted at Dothan, United States, Phoenix, United States, Duarte, United States, Irvine, United States and 11 additional locations.
Who is sponsoring the NCT07611110 clinical trial?
NCT07611110 is sponsored by AstraZeneca. The trial plans to enroll 670 participants.
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