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Estudo de Fase III comparando AAA817+ARPI versus padrão de atendimento em participantes adultos com mCRPC positivo para PSMA (AcTFirst)

14 de outubro de 2026 atualizado por: Novartis Pharmaceuticals

Um estudo randomizado de fase III, com rótulo aberto, multicêntrico, comparando AAA817+ARPI versus padrão de atendimento em participantes adultos com câncer de próstata resistente a castração metastática positivo 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

940

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Novartis Pharmaceuticals
  • Número de telefone: +41613241111

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 100 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Macho

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Investigational Arm: AAA817+ARPI (enzalutamide or abiraterone)

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

Outros nomes:
  • [225Ac]Ac-PSMA-617
Medicamento: 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.

Outros nomes:
  • Enzalutamida ou abiraterona
Experimental: Investigational Arm: AAA817

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

Outros nomes:
  • [225Ac]Ac-PSMA-617
Comparador Ativo: 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.
Medicamento: 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.

Outros nomes:
  • Enzalutamida ou abiraterona
Medicamento: 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).

Outros nomes:
  • Arpi enzalutamida
  • ARPI ABIRATERONE
  • Quimioterapia baseada em taxano de docetaxel
  • Quimioterapia baseada em taxano de cabazitaxel
  • [177Lu]Lu-PSMA-617 (AAA617)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Radiographic Progression Free Survival (rPFS)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival (OS) (Key Secondary Endpoint)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

Investigadores

  • Diretor de estudo: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de julho de 2025

Conclusão Primária (Estimado)

29 de setembro de 2028

Conclusão do estudo (Estimado)

4 de novembro de 2032

Datas de inscrição no estudo

Enviado pela primeira vez

18 de fevereiro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de fevereiro de 2025

Primeira postagem (Real)

3 de março de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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