Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Fase III-undersøgelse, der sammenligner AAA817+ARPI versus standard for pleje hos voksne deltagere med PSMA-positiv MCRPC (AcTFirst)

14. oktober 2026 opdateret af: Novartis Pharmaceuticals

En fase III, open-label, multicenter, randomiseret undersøgelse, der sammenligner AAA817+ARPI versus standard for pleje hos voksne deltagere med PSMA-positiv metastatisk kastrationsresistent prostatacancer

The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or [177Lu]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

This is a phase III, open label, multicenter randomized study. The study aims at evaluating the superiority of 225Ac-PSMA-617 combined with androgen receptor pathway inhibitor (ARPI) over a change of ARPI or chemotherapy or [177Lu]Lu-PSMA-617 (AAA617) in prolonging progression free survival (rPFS).

Screening period: At screening, the participants will be assessed for eligibility and will undergo a positron emission tomography (PET)/computed tomography (CT) scan to evaluate PSMA positivity. Only participants with PSMA positive cancer and confirmed eligibility criteria will be randomized.

Participants randomized to the investigational arms will receive up to 6 doses of AAA817 10 Mbq +/- 10% given intravenously with or without an ARPI (oral enzalutamide or oral abiraterone) per investigator's choice. Treatment with ARPI should continue as per protocol end of treatment criteria.

Participants randomized to SoC will be treated with an ARPI change (oral enzalutamide or oral abiraterone) or taxane-based chemotherapy (docetaxel or cabazitaxel) or [177Lu]Lu-PSMA-617 (AAA617)' per investigator's choice. Treatment with ARPI should continue as per protocol end of treatment criteria. Treatment duration with taxane-based chemotherapy or AAA617will depend on the chosen regimen per the investigator's discretion following local guidelines as per standard of care and product labels and adhere to the protocol end of treatment criteria.

Supportive care will be allowed in both arms at the discretion of the investigator and includes available care for the eligible participant according to best institutional practice for mCRPC treatment, including androgen deprivation therapy (ADT).

Safety will be assessed routinely during the study. Crossover is not allowed among study arms.

The study will be conducted in the USA among other countries globally.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
940

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

  • Navn: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studiesteder

  • Australien
      • Adelaide, Australien, 5000
        • Rekruttering
        • Novartis Investigative Site
    • New South Wales
      • Darlinghurst, New South Wales, Australien, 2010
        • Rekruttering
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Rekruttering
        • Novartis Investigative Site
    • Victoria
      • Malvern, Victoria, Australien, 3144
        • Rekruttering
        • Novartis Investigative Site
    • Western Australia
      • Murdoch, Western Australia, Australien, 6150
        • Rekruttering
        • Novartis Investigative Site
  • Brasilien
    • São Paulo
      • São Paulo, São Paulo, Brasilien, 01308-050
        • Rekruttering
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brasilien, 05652-000
        • Rekruttering
        • Novartis Investigative Site
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, EC1A 7BE
        • Rekruttering
        • Novartis Investigative Site
    • Oxfordshire
      • Oxford, Oxfordshire, Det Forenede Kongerige, OX4 6LB
        • Rekruttering
        • Novartis Investigative Site
    • Surrey
      • Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
        • Rekruttering
        • Novartis Investigative Site
      • Windsor, Surrey, Det Forenede Kongerige, SL4 3HD
        • Rekruttering
        • Novartis Investigative Site
  • Forenede Stater
    • Alabama
      • Homewood, Alabama, Forenede Stater, 35209
        • Rekruttering
        • Urology Centers Of Alabama Pc
        • Kontakt:
        • Ledende efterforsker:
          • Bryant Poole
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85724
        • Rekruttering
        • University of Arizona
        • Kontakt:
        • Ledende efterforsker:
          • Bital Savir-Baruch
    • California
      • Orange, California, Forenede Stater, 92868
        • Rekruttering
        • Univ Cali Irvine ALS Neuromuscular
        • Ledende efterforsker:
          • Arash Rezazadeh Kalebasty
        • Kontakt:
      • Palo Alto, California, Forenede Stater, 94304
        • Rekruttering
        • Stanford University Medical Center
        • Ledende efterforsker:
          • Hong Song
        • Kontakt:
      • Santa Barbara, California, Forenede Stater, 93105
        • Rekruttering
        • Sansum Clinic
        • Kontakt:
        • Ledende efterforsker:
          • Mukul Gupta
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Rekruttering
        • Rocky Mountain Cancer Centers
        • Ledende efterforsker:
          • Allen Cohn
        • Kontakt:
    • Florida
      • Fort Myers, Florida, Forenede Stater, 33901
        • Rekruttering
        • Florida Cancer Specialists
        • Ledende efterforsker:
          • Bradford Perez
        • Kontakt:
      • Miami, Florida, Forenede Stater, 33173
      • Orlando, Florida, Forenede Stater, 32804
        • Rekruttering
        • AdventHealth
        • Ledende efterforsker:
          • Ravi Shridhar
        • Kontakt:
    • Georgia
      • Athens, Georgia, Forenede Stater, 30607
        • Rekruttering
        • University Cancer and Blood Center LLC
        • Kontakt:
        • Ledende efterforsker:
          • Gordon Schoenfeld
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Rekruttering
        • Northwestern University
        • Kontakt:
        • Ledende efterforsker:
          • Maha Hussain
      • Chicago, Illinois, Forenede Stater, 60612
        • Rekruttering
        • University of Illinois Cancer Center at Chicago
        • Ledende efterforsker:
          • Natalie Reizine
        • Kontakt:
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Rekruttering
        • Univ Of Iowa Hospitals And Clinics
        • Kontakt:
        • Ledende efterforsker:
          • Kristin Plichta
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Rekruttering
        • University of Kansas Hospital
        • Ledende efterforsker:
          • Xinglei Shen
        • Kontakt:
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
    • Maine
      • Scarborough, Maine, Forenede Stater, 04074
        • Rekruttering
        • New England Cancer Specialists
        • Kontakt:
        • Ledende efterforsker:
          • Christian Anton Thomas
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Rekruttering
        • Johns Hopkins Hospital
        • Ledende efterforsker:
          • Ana Kiess
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
      • Boston, Massachusetts, Forenede Stater, 02215
        • Rekruttering
        • Beth Israel Deaconess Med Center
        • Ledende efterforsker:
          • Glenn Bubley
        • Kontakt:
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Rekruttering
        • Karmanos Cancer Institute
        • Kontakt:
        • Ledende efterforsker:
          • Nitin Vaishampayan
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Rekruttering
        • Wash U School of Medicine
        • Ledende efterforsker:
          • Jeff Michalski
        • Kontakt:
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68154
    • New Jersey
      • East Brunswick, New Jersey, Forenede Stater, 08816
      • Voorhees Township, New Jersey, Forenede Stater, 08043
        • Rekruttering
        • New Jersey Urology LLC
        • Kontakt:
        • Ledende efterforsker:
          • Gordon Brown
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • Rekruttering
        • New Mexico Oncology Hematology
        • Kontakt:
        • Ledende efterforsker:
          • Gregg Franklin
    • New York
      • Cooperstown, New York, Forenede Stater, 13326
        • Rekruttering
        • Bassett Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Timothy Korytko
      • New York, New York, Forenede Stater, 10021
        • Rekruttering
        • Weill Cornell Medicine NY-Presb
        • Ledende efterforsker:
          • Scott Tagawa
        • Kontakt:
      • Rochester, New York, Forenede Stater, 14642
      • Syracuse, New York, Forenede Stater, 13210
        • Rekruttering
        • Associated Med Professionals of NY
        • Ledende efterforsker:
          • Steven Finkelstein
        • Kontakt:
      • The Bronx, New York, Forenede Stater, 10461
        • Rekruttering
        • Montefiore Medical Center
        • Ledende efterforsker:
          • Benjamin A Gartrell
        • Kontakt:
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45212
        • Rekruttering
        • Urology Group - Solaris Network
        • Kontakt:
        • Ledende efterforsker:
          • Marc Pliskin
      • Gahanna, Ohio, Forenede Stater, 43230
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Rekruttering
        • MUSC Hollings Cancer Center
        • Ledende efterforsker:
          • Kevin Becker
        • Kontakt:
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
        • Rekruttering
        • Carolina Urologic Research Center
        • Ledende efterforsker:
          • Neal D Shore
        • Kontakt:
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Rekruttering
        • Tennessee Oncology PLLC
        • Ledende efterforsker:
          • Katy Beckermann
        • Kontakt:
    • Texas
      • Lakeway, Texas, Forenede Stater, 78738
      • San Antonio, Texas, Forenede Stater, 78229
      • The Woodlands, Texas, Forenede Stater, 77384
        • Rekruttering
        • Woodlands Cancer Institute American Oncology Partners
        • Kontakt:
        • Ledende efterforsker:
          • Jason Berilgen
    • Washington
      • Seattle, Washington, Forenede Stater, 98122-4379
        • Rekruttering
        • Swedish Medical Center
        • Ledende efterforsker:
          • Song Zhao
        • Kontakt:
      • Tacoma, Washington, Forenede Stater, 98405
        • Rekruttering
        • Northwest Medical Specialties
        • Ledende efterforsker:
          • Li Zhang
        • Kontakt:
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • Rekruttering
        • West Virginia University Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Raheel Siddiqui
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Rekruttering
        • Medical College of Wisconsin
        • Ledende efterforsker:
          • Deepak Kilari
        • Kontakt:
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Rekruttering
        • Novartis Investigative Site
  • Indien
    • Haryana
      • Gurgaon, Haryana, Indien, 122002
        • Rekruttering
        • Novartis Investigative Site
    • Karnataka
      • Bengaluru, Karnataka, Indien, 560066
        • Rekruttering
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, Indien, 400012
        • Rekruttering
        • Novartis Investigative Site
  • Japan
      • Chiba, Japan, 2608717
        • Rekruttering
        • Novartis Investigative Site
      • Fukuoka, Japan, 8128582
        • Rekruttering
        • Novartis Investigative Site
      • Fukuoka, Japan, 8110213
        • Rekruttering
        • Novartis Investigative Site
      • Fukuoka, Japan, 8120033
        • Rekruttering
        • Novartis Investigative Site
      • Fukushima, Japan, 9601295
        • Rekruttering
        • Novartis Investigative Site
      • Hiroshima, Japan, 7348551
        • Rekruttering
        • Novartis Investigative Site
      • Kyoto, Japan, 6068507
        • Rekruttering
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4668560
        • Rekruttering
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608648
        • Rekruttering
        • Novartis Investigative Site
    • Hyōgo
      • Kobe, Hyōgo, Japan, 6500047
        • Rekruttering
        • Novartis Investigative Site
      • Kobe, Hyōgo, Japan, 6500017
        • Rekruttering
        • Novartis Investigative Site
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 2478533
        • Rekruttering
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 2360004
        • Rekruttering
        • Novartis Investigative Site
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 8608556
        • Rekruttering
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 1040045
        • Rekruttering
        • Novartis Investigative Site
  • Kina
      • Beijing, Kina, 100036
        • Rekruttering
        • Novartis Investigative Site
      • Beijing, Kina, 100034
        • Rekruttering
        • Novartis Investigative Site
      • Guangzhou, Kina, 510060
        • Rekruttering
        • Novartis Investigative Site
      • Shanghai, Kina, 200025
        • Rekruttering
        • Novartis Investigative Site
      • Shanghai, Kina, 200032
        • Rekruttering
        • Novartis Investigative Site
      • Shanghai, Kina, 200001
        • Rekruttering
        • Novartis Investigative Site
      • Tianjin, Kina, 300480
        • Rekruttering
        • Novartis Investigative Site
      • Tianjin, Kina, 300300
        • Rekruttering
        • Novartis Investigative Site
    • Fujian
      • Fuzhou, Fujian, Kina, 350025
        • Rekruttering
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510120
        • Rekruttering
        • Novartis Investigative Site
      • Guangzhou, Guangdong, Kina, 510632
        • Rekruttering
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Rekruttering
        • Novartis Investigative Site
      • Wuhan, Hubei, Kina, 430030
        • Rekruttering
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210006
        • Rekruttering
        • Novartis Investigative Site
      • Nanjing, Jiangsu, Kina, 210029
        • Rekruttering
        • Novartis Investigative Site
    • Liaoning
      • Shenyang, Liaoning, Kina, 110011
        • Rekruttering
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Rekruttering
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310022
        • Rekruttering
        • Novartis Investigative Site
      • Hangzhou, Zhejiang, Kina, 310007
        • Rekruttering
        • Novartis Investigative Site
  • Mexico
      • Mexico City, Mexico, 03330
        • Rekruttering
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169608
        • Rekruttering
        • Novartis Investigative Site
      • Singapore, Singapore, 119074
        • Rekruttering
        • Novartis Investigative Site
      • Singapore, Singapore, 168583
        • Rekruttering
        • Novartis Investigative Site
  • Sydkorea
      • Seoul, Sydkorea, 03080
        • Rekruttering
        • Novartis Investigative Site
      • Seoul, Sydkorea, 05505
        • Rekruttering
        • Novartis Investigative Site
      • Seoul, Sydkorea, 06591
        • Rekruttering
        • Novartis Investigative Site
      • Seoul, Sydkorea, 03722
        • Rekruttering
        • Novartis Investigative Site
      • Seoul, Sydkorea, 06351
        • Rekruttering
        • Novartis Investigative Site
      • Seoul, Sydkorea, 01812
        • Rekruttering
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Rekruttering
        • Novartis Investigative Site
      • Taichung, Taiwan, 407219
        • Rekruttering
        • Novartis Investigative Site
      • Tainan, Taiwan, 704302
        • Rekruttering
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Rekruttering
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Rekruttering
        • Novartis Investigative 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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Key Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.

  • Participants must be adults ≥ 18 years of age.

  • Participants must have an ECOG performance status of 0 to 2.

  • Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.

  • Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.

  • Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).

  • Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.

  • Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).

    • Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.

Key Exclusion Criteria:

  • Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, [177Lu]Lu-PSMA, [177Lu]-DOTA, or Radium- 223.)

  • Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).

    • Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.

Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.

Other protocol-defined inclusion/exclusion criteria may apply.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Investigational Arm: AAA817+ARPI (enzalutamide or abiraterone)

Participants will receive AAA817 infusion directly into a vein with ARPIs.
Medicin: AAA817

AAA817 is being studied for treating PSMA positive mCRPC. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them. This treatment is also called a radioligand therapy.

Andre navne:
  • [225Ac]Ac-PSMA-617
Medicin: ARPI

Androgen receptor pathway inhibitor (ARPI): An ARPI is approved for the treatment of prostate cancer. It works by blocking signals from male hormones, such as testosterone, that helps cancer cells grow. By blocking these signals, an ARPI slows down or stops the growth of prostate cancer cells. In this trial, participants will be given either enzalutamide or abiraterone.

Andre navne:
  • Enzalutamid eller abirateron
Eksperimentel: Investigational Arm: AAA817

Participants will receive AAA817 infusion directly into a vein.
Medicin: AAA817

AAA817 is being studied for treating PSMA positive mCRPC. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them. This treatment is also called a radioligand therapy.

Andre navne:
  • [225Ac]Ac-PSMA-617
Aktiv komparator: Control arm: Investigator's choice of SoC (ARPI or chemotherapy or AAA617)

Participants will receive standard treatment as decided by the trial doctor either as a taxane-based chemotherapy infusion directly into a vein or ARPI change either as capsules or tablets or AAA617 monotherapy infusion directly into a vein.
Medicin: ARPI

Androgen receptor pathway inhibitor (ARPI): An ARPI is approved for the treatment of prostate cancer. It works by blocking signals from male hormones, such as testosterone, that helps cancer cells grow. By blocking these signals, an ARPI slows down or stops the growth of prostate cancer cells. In this trial, participants will be given either enzalutamide or abiraterone.

Andre navne:
  • Enzalutamid eller abirateron
Medicin: Standard of Care

Standard treatment includes approved treatment for mCRPC. In this trial, the trial doctor will decide which available treatment participants will receive. The trial doctor will select either an ARPI of enzalutamide or abiraterone, or a taxane based chemotherapy of docetaxel or cabazitaxel or [177Lu]Lu-PSMA-617 (AAA617).

Andre navne:
  • Arpi Enzalutamid
  • Arpi Abiraterone
  • Taxanbaseret kemoterapi af docetaxel
  • Taxanbaseret kemoterapi af Cabazitaxel
  • [177Lu]Lu-PSMA-617 (AAA617)

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Radiographic Progression Free Survival (rPFS)
Tidsramme: From the date of randomization to the date of the first documented radiographic disease progression using conventional imaging, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to radiographic disease progression or death due to any cause.
From the date of randomization to the date of the first documented radiographic disease progression using conventional imaging, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS) (Key Secondary Endpoint)
Tidsramme: From the date of randomization to the date of death due to any cause, assessed up to approximately 40 months.

Time to death due to any cause.
From the date of randomization to the date of death due to any cause, assessed up to approximately 40 months.
Radiographic Progression Free Survival by by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 (Key Secondary)
Tidsramme: From date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to radiographic disease progression, using by blinded independent central review (BICR) using conventional imaging and Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 criteria or death due to any cause.
From date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Overall Survival in participants with PSMA-positive mCRPC treated with another ARPI. (Key Secondary)
Tidsramme: From the date of randomization to the date of death due to any cause.

Time to death due to any cause.
From the date of randomization to the date of death due to any cause.
rPFS in participants treated with AAA817
Tidsramme: From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

rPFS time to the date of first documented radiographic disease progression or death due to any cause, whichever occurs first.
From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Progression Free Survival (PFS)
Tidsramme: From date of randomization to the first documented progression by investigator's assessment or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to first documented progression or death due to any cause.
From date of randomization to the first documented progression by investigator's assessment or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Progression Free Survival (PFS2)
Tidsramme: From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to approximately 40.0 months.

Time to first documented progression on next line of antineoplastic therapy or death from any cause.
From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to approximately 40.0 months.
Overall Response Rate (ORR)
Tidsramme: From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

The proportion of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) in soft tissue.
From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Disease Control Rate (DCR)
Tidsramme: From the date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

The proportion of participants with BOR of confirmed CR, PR, stable disease (SD) or non-CR/non-progressive disease (PD) in soft tissue.
From the date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Duration of Response (DoR)
Tidsramme: From the date of first documented response (CR or PR) for confirmed responders and the date of first documented radiographic progression in soft tissue or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time between the date of first documented response and the date of first documented radiographic progression or death due to any cause.
From the date of first documented response (CR or PR) for confirmed responders and the date of first documented radiographic progression in soft tissue or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Time to first radiographic soft tissue progression (TTSTP)
Tidsramme: From the date of randomization to the date of radiographic soft tissue progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to radiographic soft tissue progression.
From the date of randomization to the date of radiographic soft tissue progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Time to first symptomatic skeletal event (TTSSE)
Tidsramme: From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to date of first new symptomatic skeletal event of death due to any cause.
From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Prostate specific antigen response (PSA50 and PSA90)
Tidsramme: From the date of randomization to the date of safety follow up, assessed up to approximately 40.0 months.

The percentage of participants who achieved ≥ 50% and ≥ 90% decrease from baseline, respectively.
From the date of randomization to the date of safety follow up, assessed up to approximately 40.0 months.
Time-concentration profiles and PK parameters of AAA817
Tidsramme: From Cycle 1 Day 1 up to approximately cycle 5 days 11 (each cycle is 8 weeks).

Time-concentration profiles and PK parameters of AAA817 (e.g. AUC, Cmax).
From Cycle 1 Day 1 up to approximately cycle 5 days 11 (each cycle is 8 weeks).
Change from baseline on FACT-P Prostate Cancer Subscale (PCS)
Tidsramme: From randomization to the first occurrence of worsening on the score or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Change from baseline on FACT-P Prostate Cancer Subscale (PCS). FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment.
From randomization to the first occurrence of worsening on the score or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Time to worsening on the Worst Pain
Tidsramme: From randomization to the first occurrence of worsening from baseline, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to worsening on the Worst Pain is defined as the time from randomization to the first occurrence of worsening on the Worst Pain item (BPI-SF) or death due to any cause, whichever occurs first.
From randomization to the first occurrence of worsening from baseline, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Samarbejdspartnere og efterforskere

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

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Novartis Pharmaceuticals

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

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)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. juli 2025

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
29. september 2028

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
4. november 2032

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
18. februar 2025

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
26. februar 2025

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
3. marts 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
15. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
14. oktober 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • CAAA817B12301
  • 2024-512340-32 (Registry Identifier: EU CTIS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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 .

Cookieindstillinger

Vi bruger cookies for at sikre, at vi giver dig den bedste oplevelse på vores hjemmeside. For flere detaljer skal du læse omhyggeligt vores Politik om beskyttelse af personlige oplysninger og cookies. ...>>>Du kan når som helst ændre dine præferencer eller trække dit samtykke tilbage ved at slette cookies fra din hjemmeside eller computer som beskrevet i politikken. Accepter det og vælg dine præferencer ved at markere de tilsvarende felter i afsnittet "Administrer indstillinger" nedenfor. Læs vores servicevilkår omhyggeligt, inden du fortsætter med at bruge nogen del af dette websted.
«Administrer indstillinger