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Studio di fase III che confronta AAA817+ARPI rispetto allo standard di cura nei partecipanti adulti con MCRPC positivo per PSMA (AcTFirst)

14 ottobre 2026 aggiornato da: Novartis Pharmaceuticals

Uno studio di fase III, in aperto, multicentrico e randomizzato che confronta AAA817+ARPI rispetto allo standard di assistenza nei partecipanti adulti con carcinoma prostatico per la castrazione metastatica positiva al 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

940

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Novartis Pharmaceuticals
  • Numero di telefono: +41613241111

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 100 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Altri nomi:
  • [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.

Altri nomi:
  • Enzalutamide o abiraterone
Sperimentale: 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.

Altri nomi:
  • [225Ac]Ac-PSMA-617
Comparatore attivo: 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.

Altri nomi:
  • Enzalutamide o abiraterone
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).

Altri nomi:
  • ARPI Enzalutamide
  • Arpi abiraterone
  • Chemioterapia a base di taxane di docetaxel
  • Chemioterapia a base di taxane di Cabazitaxel
  • [177Lu]Lu-PSMA-617 (AAA617)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Radiographic Progression Free Survival (rPFS)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS) (Key Secondary Endpoint)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Investigatori

  • Direttore dello studio: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2025

Completamento primario (Stimato)

29 settembre 2028

Completamento dello studio (Stimato)

4 novembre 2032

Date di iscrizione allo studio

Primo inviato

18 febbraio 2025

Primo inviato che soddisfa i criteri di controllo qualità

26 febbraio 2025

Primo Inserito (Effettivo)

3 marzo 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CAAA817B12301
  • 2024-512340-32 (Identificatore di registro: EU CTIS)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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