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

NCT07611110 · AstraZeneca
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Official title
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)
About this study
Approximately 670 adult participants with mCRPC will be randomized to receive either AZD2265 or standard of care treatment (investigator's choice of cabazitaxel, ARPI switch, or radium-223). They will receive their assigned treatment until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Tumor evaluation scans will continue after treatment discontinuation until radiographically confirmed progression or death. All patients will be followed for survival until the end of the study. An Independent Data Monitoring Committee (IDMC) composed of independent experts will be convened to monitor the safety and scientific integrity of the study.
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.
Study design
Enrollment target: 670 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-05-04
Estimated completion: 2029-12-20
Last updated: 2026-05-28
Interventions
Drug: AZD2265Drug: CabazitaxelDrug: AbirateroneDrug: EnzalutamideDrug: ApalutamideDrug: DarolutamideDrug: RezvilutamideDrug: Radium-223
Primary outcomes
  • Radiographic Progression-Free Survival (rPFS) (From randomization until first radiographic progression per RECIST 1.1/PCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months))
  • Overall Survival (OS) (From randomization until death from any cause (up to approximately 33 months))
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (90)
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Dothan, Alabama, United States
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Phoenix, Arizona, United States
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Irvine, California, United States
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Loma Linda, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Miami, Florida, United States
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O'Fallon, Illinois, United States
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Metairie, Louisiana, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Omaha, Nebraska, United States
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Albuquerque, New Mexico, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Myrtle Beach, South Carolina, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Darlinghurst, Australia
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Melbourne, Australia
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Linz, Austria
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Salzburg, Austria
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São Paulo, Brazil
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São Paulo, Brazil
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Chengdu, China
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Chongqing, China
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Fuzhou, China
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Guangzhou, China
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Guangzhou, China
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Guangzhou, China
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Nanjing, China
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Nanjing, China
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Shanghai, China
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Shanghai, China
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Wuhan, China
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Wuhan, China
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Villejuif, France
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Berlin, Germany
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Bonn, Germany
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Dresden, Germany
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Essen, Germany
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Karlsruhe, Germany
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Münster, Germany
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Rostock, Germany
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Tübingen, Germany
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Würzburg, Germany
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Bangalore, India
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Gurgaon, India
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Gurgaon, India
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Navi Mumbai, India
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Fukuoka, Japan
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Kanazawa, Japan
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Kashiwa, Japan
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Sapporo, Japan
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Goyang-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Barcelona, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Málaga, Spain
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Santiago de Compostela, Spain
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Kaohsiung City, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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London, United Kingdom
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Middlesbrough, United Kingdom
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Southampton, United Kingdom
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) · TrialPath