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Estudio de fase III Comparación de AAA817+ARPI versus estándar de atención en participantes adultos con MCRPC PSMA-positivo (AcTFirst)

14 de octubre de 2026 actualizado por: Novartis Pharmaceuticals

Un estudio aleatorizado de fase III, abierta, múltiple centro y aleatorizado que compara AAA817+ARPI versus estándar de atención en participantes adultos con cáncer de próstata de castración metastásica de PSMA positiva para PSMA

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

940

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Novartis Pharmaceuticals
  • Número de teléfono: +41613241111

Ubicaciones de estudio

  • Australia
      • Adelaide, Australia, 5000
        • Reclutamiento
        • Novartis Investigative Site
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Reclutamiento
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Reclutamiento
        • Novartis Investigative Site
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Reclutamiento
        • Novartis Investigative Site
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Reclutamiento
        • Novartis Investigative Site
  • Brasil
    • São Paulo
      • São Paulo, São Paulo, Brasil, 01308-050
        • Reclutamiento
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brasil, 05652-000
        • Reclutamiento
        • Novartis Investigative Site
  • Corea del Sur
      • Seoul, Corea del Sur, 03080
        • Reclutamiento
        • Novartis Investigative Site
      • Seoul, Corea del Sur, 05505
        • Reclutamiento
        • Novartis Investigative Site
      • Seoul, Corea del Sur, 06591
        • Reclutamiento
        • Novartis Investigative Site
      • Seoul, Corea del Sur, 03722
        • Reclutamiento
        • Novartis Investigative Site
      • Seoul, Corea del Sur, 06351
        • Reclutamiento
        • Novartis Investigative Site
      • Seoul, Corea del Sur, 01812
        • Reclutamiento
        • Novartis Investigative Site
  • Estados Unidos
    • Alabama
      • Homewood, Alabama, Estados Unidos, 35209
        • Reclutamiento
        • Urology Centers Of Alabama Pc
        • Contacto:
        • Investigador principal:
          • Bryant Poole
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85724
        • Reclutamiento
        • University of Arizona
        • Contacto:
        • Investigador principal:
          • Bital Savir-Baruch
    • California
      • Orange, California, Estados Unidos, 92868
        • Reclutamiento
        • Univ Cali Irvine ALS Neuromuscular
        • Investigador principal:
          • Arash Rezazadeh Kalebasty
        • Contacto:
      • Palo Alto, California, Estados Unidos, 94304
        • Reclutamiento
        • Stanford University Medical Center
        • Investigador principal:
          • Hong Song
        • Contacto:
      • Santa Barbara, California, Estados Unidos, 93105
        • Reclutamiento
        • Sansum Clinic
        • Contacto:
        • Investigador principal:
          • Mukul Gupta
    • Colorado
      • Denver, Colorado, Estados Unidos, 80218
        • Reclutamiento
        • Rocky Mountain Cancer Centers
        • Investigador principal:
          • Allen Cohn
        • Contacto:
    • Florida
      • Fort Myers, Florida, Estados Unidos, 33901
        • Reclutamiento
        • Florida Cancer Specialists
        • Investigador principal:
          • Bradford Perez
        • Contacto:
      • Miami, Florida, Estados Unidos, 33173
      • Orlando, Florida, Estados Unidos, 32804
        • Reclutamiento
        • AdventHealth
        • Investigador principal:
          • Ravi Shridhar
        • Contacto:
    • Georgia
      • Athens, Georgia, Estados Unidos, 30607
        • Reclutamiento
        • University Cancer and Blood Center LLC
        • Contacto:
        • Investigador principal:
          • Gordon Schoenfeld
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Reclutamiento
        • Northwestern University
        • Contacto:
        • Investigador principal:
          • Maha Hussain
      • Chicago, Illinois, Estados Unidos, 60612
        • Reclutamiento
        • University of Illinois Cancer Center at Chicago
        • Investigador principal:
          • Natalie Reizine
        • Contacto:
          • Ethan Gu
          • Número de teléfono: 312-413-2746
          • Correo electrónico: egu3@uic.edu
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
        • Reclutamiento
        • Univ Of Iowa Hospitals And Clinics
        • Contacto:
        • Investigador principal:
          • Kristin Plichta
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • Reclutamiento
        • University of Kansas Hospital
        • Investigador principal:
          • Xinglei Shen
        • Contacto:
    • Louisiana
      • Metairie, Louisiana, Estados Unidos, 70006
    • Maine
      • Scarborough, Maine, Estados Unidos, 04074
        • Reclutamiento
        • New England Cancer Specialists
        • Contacto:
        • Investigador principal:
          • Christian Anton Thomas
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Reclutamiento
        • Johns Hopkins Hospital
        • Investigador principal:
          • Ana Kiess
        • Contacto:
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
      • Boston, Massachusetts, Estados Unidos, 02215
        • Reclutamiento
        • Beth Israel Deaconess Med Center
        • Investigador principal:
          • Glenn Bubley
        • Contacto:
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Reclutamiento
        • Karmanos Cancer Institute
        • Contacto:
        • Investigador principal:
          • Nitin Vaishampayan
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Reclutamiento
        • Wash U School of Medicine
        • Investigador principal:
          • Jeff Michalski
        • Contacto:
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68154
        • Reclutamiento
        • Nebraska Cancer Specialists
        • Contacto:
        • Investigador principal:
          • Samuel Mehr
    • New Jersey
      • East Brunswick, New Jersey, Estados Unidos, 08816
      • Voorhees Township, New Jersey, Estados Unidos, 08043
        • Reclutamiento
        • New Jersey Urology LLC
        • Contacto:
        • Investigador principal:
          • Gordon Brown
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87109
        • Reclutamiento
        • New Mexico Oncology Hematology
        • Contacto:
          • Kimberly Demos
          • Número de teléfono: +1 505 822 3869#3867
          • Correo electrónico: kimberlyd@nmohc.com
        • Investigador principal:
          • Gregg Franklin
    • New York
      • Cooperstown, New York, Estados Unidos, 13326
        • Reclutamiento
        • Bassett Medical Center
        • Contacto:
        • Investigador principal:
          • Timothy Korytko
      • New York, New York, Estados Unidos, 10021
        • Reclutamiento
        • Weill Cornell Medicine NY-Presb
        • Investigador principal:
          • Scott Tagawa
        • Contacto:
      • Rochester, New York, Estados Unidos, 14642
        • Reclutamiento
        • University of Rochester Medical Ctr
        • Contacto:
        • Investigador principal:
          • Haoming Carl Qiu
      • Syracuse, New York, Estados Unidos, 13210
        • Reclutamiento
        • Associated Med Professionals of NY
        • Investigador principal:
          • Steven Finkelstein
        • Contacto:
      • The Bronx, New York, Estados Unidos, 10461
        • Reclutamiento
        • Montefiore Medical Center
        • Investigador principal:
          • Benjamin A Gartrell
        • Contacto:
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45212
        • Reclutamiento
        • Urology Group - Solaris Network
        • Contacto:
        • Investigador principal:
          • Marc Pliskin
      • Gahanna, Ohio, Estados Unidos, 43230
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Reclutamiento
        • MUSC Hollings Cancer Center
        • Investigador principal:
          • Kevin Becker
        • Contacto:
      • Myrtle Beach, South Carolina, Estados Unidos, 29572
        • Reclutamiento
        • Carolina Urologic Research Center
        • Investigador principal:
          • Neal D Shore
        • Contacto:
    • Tennessee
      • Chattanooga, Tennessee, Estados Unidos, 37404
        • Reclutamiento
        • Tennessee Oncology PLLC
        • Investigador principal:
          • Katy Beckermann
        • Contacto:
    • Texas
      • Lakeway, Texas, Estados Unidos, 78738
      • San Antonio, Texas, Estados Unidos, 78229
      • The Woodlands, Texas, Estados Unidos, 77384
        • Reclutamiento
        • Woodlands Cancer Institute American Oncology Partners
        • Contacto:
        • Investigador principal:
          • Jason Berilgen
    • Washington
      • Seattle, Washington, Estados Unidos, 98122-4379
        • Reclutamiento
        • Swedish Medical Center
        • Investigador principal:
          • Song Zhao
        • Contacto:
      • Tacoma, Washington, Estados Unidos, 98405
        • Reclutamiento
        • Northwest Medical Specialties
        • Investigador principal:
          • Li Zhang
        • Contacto:
    • West Virginia
      • Morgantown, West Virginia, Estados Unidos, 26506
        • Reclutamiento
        • West Virginia University Hospital
        • Contacto:
        • Investigador principal:
          • Raheel Siddiqui
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Reclutamiento
        • Medical College of Wisconsin
        • Investigador principal:
          • Deepak Kilari
        • Contacto:
          • Mariah Ziegler
          • Número de teléfono: 414-805-5249
          • Correo electrónico: mziegler@mcw.edu
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Reclutamiento
        • Novartis Investigative Site
  • India
    • Haryana
      • Gurgaon, Haryana, India, 122002
        • Reclutamiento
        • Novartis Investigative Site
    • Karnataka
      • Bengaluru, Karnataka, India, 560066
        • Reclutamiento
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Reclutamiento
        • Novartis Investigative Site
  • Japón
      • Chiba, Japón, 2608717
        • Reclutamiento
        • Novartis Investigative Site
      • Fukuoka, Japón, 8128582
        • Reclutamiento
        • Novartis Investigative Site
      • Fukuoka, Japón, 8110213
        • Reclutamiento
        • Novartis Investigative Site
      • Fukuoka, Japón, 8120033
        • Reclutamiento
        • Novartis Investigative Site
      • Fukushima, Japón, 9601295
        • Reclutamiento
        • Novartis Investigative Site
      • Hiroshima, Japón, 7348551
        • Reclutamiento
        • Novartis Investigative Site
      • Kyoto, Japón, 6068507
        • Reclutamiento
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japón, 4668560
        • Reclutamiento
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japón, 0608648
        • Reclutamiento
        • Novartis Investigative Site
    • Hyōgo
      • Kobe, Hyōgo, Japón, 6500047
        • Reclutamiento
        • Novartis Investigative Site
      • Kobe, Hyōgo, Japón, 6500017
        • Reclutamiento
        • Novartis Investigative Site
    • Kanagawa
      • Kamakura, Kanagawa, Japón, 2478533
        • Reclutamiento
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japón, 2360004
        • Reclutamiento
        • Novartis Investigative Site
    • Kumamoto
      • Kumamoto, Kumamoto, Japón, 8608556
        • Reclutamiento
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, Japón, 1040045
        • Reclutamiento
        • Novartis Investigative Site
  • México
      • Mexico City, México, 03330
        • Reclutamiento
        • Novartis Investigative Site
  • Porcelana
      • Beijing, Porcelana, 100036
        • Reclutamiento
        • Novartis Investigative Site
      • Beijing, Porcelana, 100034
        • Reclutamiento
        • Novartis Investigative Site
      • Guangzhou, Porcelana, 510060
        • Reclutamiento
        • Novartis Investigative Site
      • Shanghai, Porcelana, 200025
        • Reclutamiento
        • Novartis Investigative Site
      • Shanghai, Porcelana, 200032
        • Reclutamiento
        • Novartis Investigative Site
      • Shanghai, Porcelana, 200001
        • Reclutamiento
        • Novartis Investigative Site
      • Tianjin, Porcelana, 300480
        • Reclutamiento
        • Novartis Investigative Site
      • Tianjin, Porcelana, 300300
        • Reclutamiento
        • Novartis Investigative Site
    • Fujian
      • Fuzhou, Fujian, Porcelana, 350025
        • Reclutamiento
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510120
        • Reclutamiento
        • Novartis Investigative Site
      • Guangzhou, Guangdong, Porcelana, 510632
        • Reclutamiento
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, Porcelana, 430022
        • Reclutamiento
        • Novartis Investigative Site
      • Wuhan, Hubei, Porcelana, 430030
        • Reclutamiento
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana, 210006
        • Reclutamiento
        • Novartis Investigative Site
      • Nanjing, Jiangsu, Porcelana, 210029
        • Reclutamiento
        • Novartis Investigative Site
    • Liaoning
      • Shenyang, Liaoning, Porcelana, 110011
        • Reclutamiento
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610041
        • Reclutamiento
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310022
        • Reclutamiento
        • Novartis Investigative Site
      • Hangzhou, Zhejiang, Porcelana, 310007
        • Reclutamiento
        • Novartis Investigative Site
  • Reino Unido
      • London, Reino Unido, EC1A 7BE
        • Reclutamiento
        • Novartis Investigative Site
    • Oxfordshire
      • Oxford, Oxfordshire, Reino Unido, OX4 6LB
        • Reclutamiento
        • Novartis Investigative Site
    • Surrey
      • Sutton, Surrey, Reino Unido, SM2 5PT
        • Reclutamiento
        • Novartis Investigative Site
      • Windsor, Surrey, Reino Unido, SL4 3HD
        • Reclutamiento
        • Novartis Investigative Site
  • Singapur
      • Singapore, Singapur, 169608
        • Reclutamiento
        • Novartis Investigative Site
      • Singapore, Singapur, 119074
        • Reclutamiento
        • Novartis Investigative Site
      • Singapore, Singapur, 168583
        • Reclutamiento
        • Novartis Investigative Site
  • Taiwán
      • Kaohsiung City, Taiwán, 833
        • Reclutamiento
        • Novartis Investigative Site
      • Taichung, Taiwán, 407219
        • Reclutamiento
        • Novartis Investigative Site
      • Tainan, Taiwán, 704302
        • Reclutamiento
        • Novartis Investigative Site
      • Taipei, Taiwán, 10002
        • Reclutamiento
        • Novartis Investigative Site
      • Taoyuan, Taiwán, 33305
        • Reclutamiento
        • Novartis Investigative Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 100 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Masculino

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Investigational Arm: AAA817+ARPI (enzalutamide or abiraterone)

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

Otros nombres:
  • [225Ac]Ac-PSMA-617
Droga: 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.

Otros nombres:
  • Enzalutamida o abiraterona
Experimental: Investigational Arm: AAA817

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

Otros nombres:
  • [225Ac]Ac-PSMA-617
Comparador activo: 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.
Droga: 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.

Otros nombres:
  • Enzalutamida o abiraterona
Droga: 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).

Otros nombres:
  • Arpi enzalutamida
  • Arpi abiraterone
  • Quimioterapia basada en taxanes de Docetaxel
  • Quimioterapia basada en taxanes de Cabazitaxel
  • [177Lu]Lu-PSMA-617 (AAA617)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Radiographic Progression Free Survival (rPFS)
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS) (Key Secondary Endpoint)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Investigadores

  • Director de estudio: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de julio de 2025

Finalización primaria (Estimado)

29 de septiembre de 2028

Finalización del estudio (Estimado)

4 de noviembre de 2032

Fechas de registro del estudio

Enviado por primera vez

18 de febrero de 2025

Primero enviado que cumplió con los criterios de control de calidad

26 de febrero de 2025

Publicado por primera vez (Actual)

3 de marzo de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CAAA817B12301
  • 2024-512340-32 (Identificador de registro: EU CTIS)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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