AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

Recruiting now · Phase 3

Conditions studied: Metastatic Castration-resistant Prostate Cancer

In brief

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.

Key facts

Study ID: NCT07611110
Run by: AstraZeneca
People needed: 670
Starts: 2026-05-04
Expected to finish: 2029-12-20
Last updated by the study team: 2026-07-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

≥ 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.

You may not qualify if…

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 it is running

Research Site — Montreal, Quebec, Canada (enrolling)
Research Site — Newport Beach, California, United States (enrolling)
Research Site — Miami, Florida, United States (enrolling)
Research Site — Omaha, Nebraska, United States (enrolling)
Research Site — San Francisco, California, United States
Research Site — Aurora, Colorado, United States
Research Site — Duarte, California, United States
Research Site — Pittsburgh, Pennsylvania, United States
Research Site — Metairie, Louisiana, United States
Research Site — Detroit, Michigan, United States
Research Site — Grand Rapids, Michigan, United States
Research Site — O'Fallon, Illinois, United States
Research Site — Albuquerque, New Mexico, United States
Research Site — New Hyde Park, New York, United States
Research Site — Cleveland, Ohio, United States
Research Site — New York, New York, United States
Research Site — Dayton, Ohio, United States
Research Site — Portland, Oregon, United States
Research Site — Irvine, California, United States
Research Site — Myrtle Beach, South Carolina, United States
Research Site — Nashville, Tennessee, United States
Research Site — Houston, Texas, United States
Research Site — Salt Lake City, Utah, United States
Research Site — Tacoma, Washington, United States
Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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