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

20. maj 2026 opdateret af: AstraZeneca

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)

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

670

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
      • Darlinghurst, Australien, 2010
        • Ikke rekrutterer endnu
        • Research Site
      • Melbourne, Australien, 3000
        • Ikke rekrutterer endnu
        • Research Site
  • Brasilien
      • São Paulo, Brasilien, 05652-900
        • Ikke rekrutterer endnu
        • Research Site
      • São Paulo, Brasilien, 01308-050
        • Ikke rekrutterer endnu
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Ikke rekrutterer endnu
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Ikke rekrutterer endnu
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Ikke rekrutterer endnu
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Ikke rekrutterer endnu
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Ikke rekrutterer endnu
        • Research Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Ikke rekrutterer endnu
        • Research Site
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, EC1A 7BE
        • Ikke rekrutterer endnu
        • Research Site
      • Middlesbrough, Det Forenede Kongerige, TS4 3BW
        • Ikke rekrutterer endnu
        • Research Site
      • Southampton, Det Forenede Kongerige, SO16 6YD
        • Ikke rekrutterer endnu
        • Research Site
  • Forenede Stater
    • Alabama
      • Dothan, Alabama, Forenede Stater, 36303
        • Ikke rekrutterer endnu
        • Research Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85004
        • Ikke rekrutterer endnu
        • Research Site
    • California
      • Irvine, California, Forenede Stater, 92618
        • Ikke rekrutterer endnu
        • Research Site
      • Loma Linda, California, Forenede Stater, 92354
        • Ikke rekrutterer endnu
        • Research Site
      • San Francisco, California, Forenede Stater, 94143
        • Ikke rekrutterer endnu
        • Research Site
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Ikke rekrutterer endnu
        • Research Site
    • Florida
      • Miami, Florida, Forenede Stater, 33165
        • Rekruttering
        • Research Site
    • Illinois
      • O'Fallon, Illinois, Forenede Stater, 62269
        • Ikke rekrutterer endnu
        • Research Site
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
        • Ikke rekrutterer endnu
        • Research Site
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Ikke rekrutterer endnu
        • Research Site
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Ikke rekrutterer endnu
        • Research Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68130
        • Rekruttering
        • Research Site
      • Omaha, Nebraska, Forenede Stater, 68130
        • Ikke rekrutterer endnu
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • Ikke rekrutterer endnu
        • Research Site
    • New York
      • New Hyde Park, New York, Forenede Stater, 11042
        • Ikke rekrutterer endnu
        • Research Site
      • New York, New York, Forenede Stater, 10065
        • Ikke rekrutterer endnu
        • Research Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Ikke rekrutterer endnu
        • Research Site
      • Dayton, Ohio, Forenede Stater, 45415
        • Ikke rekrutterer endnu
        • Research Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Ikke rekrutterer endnu
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • Ikke rekrutterer endnu
        • Research Site
    • South Carolina
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
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        • Research Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Ikke rekrutterer endnu
        • Research Site
    • Texas
      • Houston, Texas, Forenede Stater, 77042
        • Ikke rekrutterer endnu
        • Research Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Ikke rekrutterer endnu
        • Research Site
  • Frankrig
      • Villejuif, Frankrig, 94800
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        • Research Site
  • Indien
      • Bangalore, Indien, 560017
        • Ikke rekrutterer endnu
        • Research Site
      • Gurgaon, Indien, 122002
        • Ikke rekrutterer endnu
        • Research Site
      • Gurgaon, Indien, 122001
        • Ikke rekrutterer endnu
        • Research Site
      • Navi Mumbai, Indien, 410210
        • Ikke rekrutterer endnu
        • Research Site
  • Japan
      • Fukuoka, Japan, 812-8582
        • Ikke rekrutterer endnu
        • Research Site
      • Kanazawa, Japan, 920-8641
        • Ikke rekrutterer endnu
        • Research Site
      • Kashiwa, Japan, 227-8577
        • Ikke rekrutterer endnu
        • Research Site
      • Sapporo, Japan, 060-8638
        • Ikke rekrutterer endnu
        • Research Site
  • Kina
      • Beijing, Kina, 100034
        • Ikke rekrutterer endnu
        • Research Site
      • Chengdu, Kina, 610041
        • Ikke rekrutterer endnu
        • Research Site
      • Chongqing, Kina, 400030
        • Ikke rekrutterer endnu
        • Research Site
      • Fuzhou, Kina, 350005
        • Ikke rekrutterer endnu
        • Research Site
      • Guangzhou, Kina, 510060
        • Ikke rekrutterer endnu
        • Research Site
      • Guangzhou, Kina, 510630
        • Ikke rekrutterer endnu
        • Research Site
      • Guangzhou, Kina, 510120
        • Ikke rekrutterer endnu
        • Research Site
      • Nanjing, Kina, 210029
        • Ikke rekrutterer endnu
        • Research Site
      • Nanjing, Kina, 210006
        • Ikke rekrutterer endnu
        • Research Site
      • Shanghai, Kina, 200032
        • Ikke rekrutterer endnu
        • Research Site
      • Shanghai, Kina, 200025
        • Ikke rekrutterer endnu
        • Research Site
      • Wuhan, Kina, 430022
        • Ikke rekrutterer endnu
        • Research Site
      • Wuhan, Kina, 430030
        • Ikke rekrutterer endnu
        • Research Site
  • Spanien
      • Barcelona, Spanien, 8035
        • Ikke rekrutterer endnu
        • Research Site
      • Barcelona, Spanien, 08025
        • Ikke rekrutterer endnu
        • Research Site
      • L'Hospitalet de Llobregat, Spanien, 08908
        • Ikke rekrutterer endnu
        • Research Site
      • Madrid, Spanien, 28041
        • Ikke rekrutterer endnu
        • Research Site
      • Málaga, Spanien, 29009
        • Ikke rekrutterer endnu
        • Research Site
      • Santiago de Compostela, Spanien, 15706
        • Ikke rekrutterer endnu
        • Research Site
  • Sydkorea
      • Goyang-si, Sydkorea, 10408
        • Ikke rekrutterer endnu
        • Research Site
      • Seoul, Sydkorea, 3722
        • Ikke rekrutterer endnu
        • Research Site
      • Seoul, Sydkorea, 5505
        • Ikke rekrutterer endnu
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833401
        • Ikke rekrutterer endnu
        • Research Site
      • Taipei, Taiwan, 11259
        • Ikke rekrutterer endnu
        • Research Site
      • Taipei, Taiwan, 10002
        • Ikke rekrutterer endnu
        • Research Site
      • Taipei, Taiwan, 11217
        • Ikke rekrutterer endnu
        • Research Site
      • Taoyuan, Taiwan, 333
        • Ikke rekrutterer endnu
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Ikke rekrutterer endnu
        • Research Site
      • Bangkok, Thailand, 10210
        • Ikke rekrutterer endnu
        • Research Site
  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye), 06530
        • Ikke rekrutterer endnu
        • Research Site
      • Ankara, Tyrkiet (Türkiye), 06620
        • Ikke rekrutterer endnu
        • Research Site
      • Istanbul, Tyrkiet (Türkiye), 34098
        • Ikke rekrutterer endnu
        • Research Site
      • Istanbul, Tyrkiet (Türkiye), 34752
        • Ikke rekrutterer endnu
        • Research Site
  • Tyskland
      • Berlin, Tyskland, 13353
        • Ikke rekrutterer endnu
        • Research Site
      • Bonn, Tyskland, 53127
        • Ikke rekrutterer endnu
        • Research Site
      • Dresden, Tyskland, 01307
        • Ikke rekrutterer endnu
        • Research Site
      • Essen, Tyskland, 45122
        • Ikke rekrutterer endnu
        • Research Site
      • Karlsruhe, Tyskland, 76133
        • Ikke rekrutterer endnu
        • Research Site
      • Münster, Tyskland, 48149
        • Ikke rekrutterer endnu
        • Research Site
      • Rostock, Tyskland, 18057
        • Ikke rekrutterer endnu
        • Research Site
      • Tübingen, Tyskland, 72076
        • Ikke rekrutterer endnu
        • Research Site
      • Würzburg, Tyskland, 97080
        • Ikke rekrutterer endnu
        • Research Site
  • Østrig
      • Linz, Østrig, 4020
        • Ikke rekrutterer endnu
        • Research Site
      • Salzburg, Østrig, 5020
        • Ikke rekrutterer endnu
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A
AZD2265
Medicin: AZD2265
IV
Andre navne:
  • FPI-2265
Aktiv komparator: Arm B
Investigator's choice of cabazitaxel, ARPI switch, or radium-223
Medicin: Enzalutamid
Mundtlig
Andre navne:
  • Xtandi
Medicin: Darolutamid
Mundtlig
Andre navne:
  • Nubeqa
Medicin: Cabazitaxel
IV in combination with oral prednisone/prednisolone
Andre navne:
  • Jevtana
Medicin: Abiraterone
Oral in combination with prednisone/prednisolone
Andre navne:
  • Zytiga
Medicin: Apalutamide
Oral
Andre navne:
  • Erleada
Medicin: Rezvilutamide
Oral
Andre navne:
  • Ariane
Medicin: Radium-223
IV
Andre navne:
  • Xofigo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Radiographic Progression-Free Survival (rPFS)
Tidsramme: 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)
rPFS is defined as the time from randomisation to radiographic progression, as assessed by the BICR per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause.
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)
Tidsramme: From randomization until death from any cause (up to approximately 33 months)
OS is defined as the length of time from randomisation until the date of death due to any cause.
From randomization until death from any cause (up to approximately 33 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: From randomization until first documented progression (radiographic, clinical, or PSA progression) or death in the absence of progression, whichever occurs first (up to approximately 33 months)
PFS is defined as the time from randomisation to the earliest of progression (defined as radiographic progression assessed by BICR per RECIST 1.1 and/or PCWG3 criteria, clinical progression, or PSA progression), or death due to any cause.
From randomization until first documented progression (radiographic, clinical, or PSA progression) or death in the absence of progression, whichever occurs first (up to approximately 33 months)
Assessment of PSA50 (≥50% prostate-specific antigen reduction)
Tidsramme: From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Proportion of participants achieving a >= 50% decrease in PSA from baseline.
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Assessment of PSA90 (≥90% prostate-specific antigen reduction)
Tidsramme: From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Proportion of participants achieving >=90% decrease in PSA from baseline.
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Objective Response Rate (ORR)
Tidsramme: From baseline; assessed by BICR per RECIST 1.1/PCWG3 every 8 weeks for first 32 weeks, then every 12 weeks until radiographic progression (up to approximately 33 months)
ORR is defined as the proportion of participants with measurable soft tissue disease at baseline who have a CR or PR as determined by BICR, per RECIST 1.1 (soft tissue), in the absence of progression by PCWG3 criteria (bone).
From baseline; assessed by BICR per RECIST 1.1/PCWG3 every 8 weeks for first 32 weeks, then every 12 weeks until radiographic progression (up to approximately 33 months)
Duration of Response (DoR)
Tidsramme: From first documented response until progression per RECIST 1.1/PCWG3 by BICR, or death in the absence of progression, whichever occurs first (up to approximately 33 months)
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone) as determined by BICR or death in the absence of disease progression.
From first documented response until progression per RECIST 1.1/PCWG3 by BICR, or death in the absence of progression, whichever occurs first (up to approximately 33 months)
Symptomatic Skeletal Event-Free Survival (SSE-FS)
Tidsramme: From randomization until first symptomatic skeletal event or death from any cause, whichever occurs first (up to approximately 33 months)

SSE-FS is defined as the time from randomisation to the earliest of the following:

  • Use of radiation therapy to prevent or relieve skeletal symptoms.
  • Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).
  • Occurrence of spinal cord compression.
  • Orthopaedic surgical intervention for bone metastasis.
  • Death due to any cause.
From randomization until first symptomatic skeletal event or death from any cause, whichever occurs first (up to approximately 33 months)
Plasma concentrations of AZD2265
Tidsramme: Pre-dose and post-dose on Day 1 of Cycles 1 and 2; 3-24 hours post-dose on Cycle 1 Day 1 only (up to approximately 7 weeks)
Plasma concentrations of AZD2265 pre-dose and post-dose.
Pre-dose and post-dose on Day 1 of Cycles 1 and 2; 3-24 hours post-dose on Cycle 1 Day 1 only (up to approximately 7 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. maj 2026

Primær færdiggørelse (Anslået)

13. februar 2029

Studieafslutning (Anslået)

20. december 2029

Datoer for studieregistrering

Først indsendt

22. april 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

28. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D9735C00001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingstidsramme

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingsadgangskriterier

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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