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NCT07611110PHASE3Recruiting

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

AstraZeneca

Start Date

5/4/2026

Completion Date

12/20/2029

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.

Detailed Description

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

AZD2265

DRUG

Cabazitaxel

DRUG

Abiraterone

DRUG

Enzalutamide

DRUG

Apalutamide

DRUG

Darolutamide

DRUG

Rezvilutamide

DRUG

Radium-223

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Conditions

Metastatic Castration-resistant Prostate Cancer

Locations

Research Site

Dothan, Alabama 36303

United States

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Phoenix, Arizona 85004

United States

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Duarte, California 91010

United States

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Irvine, California 92618

United States

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Newport Beach, California 92660

United States

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San Francisco, California 94143

United States

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Aurora, Colorado 80045

United States

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Miami, Florida 33165

United States

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O'Fallon, Illinois 62269

United States

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Metairie, Louisiana 70006

United States

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Detroit, Michigan 48201

United States

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Grand Rapids, Michigan 49503

United States

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Omaha, Nebraska 68130

United States

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Albuquerque, New Mexico 87109

United States

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New Hyde Park, New York 11042

United States

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New York, New York 10065

United States

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Cleveland, Ohio 44195

United States

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Dayton, Ohio 45415

United States

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Portland, Oregon 97239

United States

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Pittsburgh, Pennsylvania 15232

United States

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Myrtle Beach, South Carolina 29572

United States

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Nashville, Tennessee 37203

United States

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Houston, Texas 77042

United States

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Salt Lake City, Utah 84106

United States

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Tacoma, Washington 98405

United States

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Darlinghurst, 2010

Australia

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Melbourne, 3000

Australia

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Linz, 4020

Austria

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Salzburg, 5020

Austria

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São Paulo, 01308-050

Brazil

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São Paulo, 05652-900

Brazil

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Edmonton, Alberta T6G 1Z2

Canada

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Halifax, Nova Scotia B3H 1V7

Canada

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Hamilton, Ontario L8V 1C3

Canada

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Toronto, Ontario M4N 3M5

Canada

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Toronto, Ontario M5G 2M9

Canada

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Montreal, Quebec H3A 1A1

Canada

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Montreal, Quebec H3T 1E2

Canada

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Beijing, 100034

China

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Beijing, 100142

China

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Chengdu, 610041

China

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Chongqing, 400030

China

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Fuzhou, 350005

China

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Guangzhou, 510060

China

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Guangzhou, 510120

China

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Guangzhou, 510630

China

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Jinan, 250117

China

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Nanjing, 210006

China

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Nanjing, 210029

China

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Shanghai, 200025

China

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Shanghai, 200032

China

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Shenyang, 110001

China

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Wuhan, 430022

China

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Wuhan, 430030

China

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Xi'an, 710061

China

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Villejuif, 94800

France

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Augsburg, 86156

Germany

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Berlin, 13353

Germany

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Bonn, 53127

Germany

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Cologne, 50937

Germany

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Dresden, 01307

Germany

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Essen, 45122

Germany

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Jena, 07747

Germany

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Karlsruhe, 76133

Germany

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München, 81675

Germany

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Münster, 48149

Germany

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Nuremberg, 90419

Germany

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Rostock, 18057

Germany

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Tübingen, 72076

Germany

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Würzburg, 97080

Germany

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Bangalore, 560017

India

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Gurgaon, 122001

India

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Gurgaon, 122002

India

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Navi Mumbai, 410210

India

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Fukuoka, 812-8582

Japan

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Kanazawa, 920-8641

Japan

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Kashiwa, 227-8577

Japan

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Sapporo, 060-8638

Japan

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Goyang-si, 10408

South Korea

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Seoul, 3722

South Korea

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Seoul, 5505

South Korea

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Barcelona, 08025

Spain

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Barcelona, 8035

Spain

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L'Hospitalet de Llobregat, 08908

Spain

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Madrid, 28041

Spain

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Majadahonda, 28222

Spain

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Málaga, 29009

Spain

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Santiago de Compostela, 15706

Spain

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Stockholm, 17176

Sweden

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Umeå, 901 85

Sweden

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Kaohsiung City, 833401

Taiwan

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Taipei, 10002

Taiwan

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Taipei, 11217

Taiwan

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Taipei, 11259

Taiwan

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Taoyuan, 333

Taiwan

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Bangkok, 10210

Thailand

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Bangkok, 10700

Thailand

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Ankara, 06530

Turkey (Türkiye)

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Ankara, 06620

Turkey (Türkiye)

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Istanbul, 34098

Turkey (Türkiye)

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Istanbul, 34752

Turkey (Türkiye)

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London, EC1A 7BE

United Kingdom

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Middlesbrough, TS4 3BW

United Kingdom

Research Site

Southampton, SO16 6YD

United Kingdom