Åbent studie, der sammenligner AAA817 versus standard for pleje i behandling af tidligere behandlede PSMA-positive mCRPC-voksne, der har sygdom udviklet sig på eller efter [177Lu]Lu-PSMA målrettet terapi (PSMAcTION)
19. september 2026 opdateret af: Novartis Pharmaceuticals
PSMAcTION: Et fase II/III, åbent, internationalt, multicenter, randomiseret studie af AAA817 versus standardbehandling i behandling af voksne deltagere med PSMA positiv metastatisk kastrationsresistent prostatacancer, der udviklede sig på eller efter [177Lu]Lu-PSMA Målrettet terapi
This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after [177Lu]Lu-PSMA targeted therapy.
Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Study CAAA817A12201 consists of 2 parts: a randomized, open-label, international, multicenter, phase II study (Phase II) to collect more information to support the proposed dose of AAA817 and a randomized, open-label, international, multicenter, 2- arm phase III study (Phase III) aimed to evaluate the efficacy and safety of proposed dose of AAA817 vs. investigator's choice of standard of care (SoC) in the treatment of adult participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who had treatments with ARPI and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy. The purpose of the phase II part (Phase II) of this study is to collect additional information to support proposed phase III dose of AAA817.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
443
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Novartis Pharmaceuticals
- Telefonnummer: 1-888-669-6682
- E-mail: novartis.email@novartis.com
Undersøgelse Kontakt Backup
- Navn: Novartis Pharmaceuticals
- Telefonnummer: +41613241111
Studiesteder
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New South Wales
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Darlinghurst, New South Wales, Australien, 2010
- Rekruttering
- Novartis Investigative Site
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Queensland
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Herston, Queensland, Australien, 4029
- Rekruttering
- Novartis Investigative Site
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Victoria
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Melbourne, Victoria, Australien, 3004
- Rekruttering
- Novartis Investigative Site
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-
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São Paulo
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São Paulo, São Paulo, Brasilien, 01308-050
- Rekruttering
- Novartis Investigative Site
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São Paulo, São Paulo, Brasilien, 05652-000
- Rekruttering
- Novartis Investigative Site
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85258
- Rekruttering
- Honor Health Research Institute
-
Ledende efterforsker:
- Michael Gordon
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Kontakt:
- Cierra Spikes
- E-mail: cspikes@honorhealth.com
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California
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Los Angeles, California, Forenede Stater, 90073
- Rekruttering
- VA Greater LA Healthcare System
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Kontakt:
- Janake Wijesuriya
- E-mail: janake.wijesuriya@va.gov
-
Ledende efterforsker:
- Gholam Reza Berenji
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Palo Alto, California, Forenede Stater, 94304-1207
- Rekruttering
- VA Palo Alto Health Care System
-
Ledende efterforsker:
- Minal Vasanawala
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Kontakt:
- Pallavi Gautam
- Telefonnummer: 650-493-5000
- E-mail: pallavi.gautam@va.gov
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Palo Alto, California, Forenede Stater, 94304
- Rekruttering
- Stanford University Medical Center
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Ledende efterforsker:
- Hong Song
-
Kontakt:
- Mikayla Easterling
- E-mail: maeast@stanford.edu
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Santa Barbara, California, Forenede Stater, 93105
- Rekruttering
- Sansum Clinic
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Ledende efterforsker:
- Gregg Newman
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Kontakt:
- Jessica Wong
- Telefonnummer: 805-563-5800
- E-mail: jessica.wong2@sutterhealth.org
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Santa Monica, California, Forenede Stater, 90404
- Rekruttering
- Saint Johns Cancer Institute
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Ledende efterforsker:
- Przemyslaw Twardowski
-
Kontakt:
- Joey Dumadag
- Telefonnummer: 310-829-8569
- E-mail: joey.dumadag@providence.org
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Colorado
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Denver, Colorado, Forenede Stater, 80218
- Rekruttering
- Rocky Mountain Cancer Centers
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Ledende efterforsker:
- Manojkumar Bupathi
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Kontakt:
- Jannae Foellmer
- Telefonnummer: 303-385-2000
- E-mail: jannae.foellmer@usoncology.com
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06102
- Rekruttering
- Hartford Hospital
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Ledende efterforsker:
- Andrew Salner
-
Kontakt:
- Melanie Manning
- E-mail: Melanie.Manning@hhchealth.org
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Florida
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Miami, Florida, Forenede Stater, 33173
- Rekruttering
- Baptist Health South
-
Ledende efterforsker:
- Adeel Kaiser
-
Kontakt:
- Leslie Castaneda
- E-mail: leslie.castaneda@baptisthealth.net
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Orlando, Florida, Forenede Stater, 32804
- Rekruttering
- AdventHealth
-
Ledende efterforsker:
- Ravi Shridhar
-
Kontakt:
- Joseph Guzzo
- Telefonnummer: 407-303-3235
- E-mail: joseph.guzzo@adventhealth.com
-
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Georgia
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Athens, Georgia, Forenede Stater, 30607
- Rekruttering
- University Cancer and Blood Center LLC
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Kontakt:
- Christen Nicole Cooper Pope
- Telefonnummer: +1 706 353 2990
- E-mail: npope@universitycancer.com
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Ledende efterforsker:
- Petros Nikolinakos
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Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Emory University
-
Ledende efterforsker:
- Shahid Sattar Ahmed
-
Kontakt:
- Jalpa Patel
- Telefonnummer: +1 404 778 1835
- E-mail: jalpa.r.patel@emory.edu
-
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- Rekruttering
- University of Chicago
-
Ledende efterforsker:
- Mohammad Atiq
-
Kontakt:
- Paige Olson
- Telefonnummer: 773-702-4848
- E-mail: paige.olson@bsd.uchicago.edu
-
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Indiana
-
Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- Indiana University
-
Ledende efterforsker:
- Nabil Adra
-
Kontakt:
- Marie Burton
- E-mail: mariburt@iu.edu
-
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Rekruttering
- University of Kansas Hospital
-
Ledende efterforsker:
- Xinglei Shen
-
Kontakt:
- Kelsey Schwensen
- E-mail: kschwensen@kumc.edu
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Louisiana
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Metairie, Louisiana, Forenede Stater, 70006
- Rekruttering
- East Jefferson Hospital
-
Ledende efterforsker:
- Alton Oliver Sartor
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Kontakt:
- Alexandra Lieberman
- E-mail: alexandra.lieberman@lcmchealth.org
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Beth Israel Deaconess Medical Center
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Ledende efterforsker:
- David J Einstein
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Kontakt:
- Ooviya Sathiyamoorthy
- Telefonnummer: 617-643-9923
- E-mail: osathiya@bidmc.harvard.edu
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Boston, Massachusetts, Forenede Stater, 02115
- Rekruttering
- Dana Farber Cancer Institute
-
Ledende efterforsker:
- Xiao Wei
-
Kontakt:
- Michael Bonhomme
- Telefonnummer: 617-632-5136
- E-mail: michael_bonhomme@dfci.harvard.edu
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- WA Uni School Of Med
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Ledende efterforsker:
- Jeff Michalski
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Kontakt:
- Collin Welch
- Telefonnummer: 314-454-8293
- E-mail: c.welch@wustl.edu
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68154
- Rekruttering
- Nebraska Cancer Specialists
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Ledende efterforsker:
- Samuel Mehr
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Kontakt:
- Marlene Bridwell
- Telefonnummer: 402-334-4773
- E-mail: mbridwell@nebraskacancer.com
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New Jersey
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Voorhees Township, New Jersey, Forenede Stater, 08043
- Rekruttering
- New Jersey Urology LLC
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Kontakt:
- Gabriela Mercado
- Telefonnummer: 856-673-1613
- E-mail: gmercado3@nj-urology.com
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Ledende efterforsker:
- Gordon Brown
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New York
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New York, New York, Forenede Stater, 10029
- Rekruttering
- Mount Sinai Hosp Med School
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Ledende efterforsker:
- Randy Yeh
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Kontakt:
- Ilda Bander
- Telefonnummer: 212-241-8903
- E-mail: Ilda.Bander@mountsinai.org
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Syracuse, New York, Forenede Stater, 13210
- Rekruttering
- Associated Med Professionals of NY
-
Ledende efterforsker:
- Steven Finkelstein
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Kontakt:
- Nathan Forrest
- E-mail: nathan.forrest@ampofny.com
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The Bronx, New York, Forenede Stater, 10467
- Rekruttering
- Montefiore Medical Center
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Ledende efterforsker:
- Benjamin A Gartrell
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Kontakt:
- Tahrima Chowdhury
- Telefonnummer: 718-920-6642
- E-mail: tahchowdhu@montefiore.org
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Ohio
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Gahanna, Ohio, Forenede Stater, 43230
- Rekruttering
- Central Ohio Urology Group
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Ledende efterforsker:
- Benjamin Martin
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Kontakt:
- Sarah Faisal
- E-mail: sarah.faisal@us-uro.com
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Oregon
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Springfield, Oregon, Forenede Stater, 97477
- Rekruttering
- Oregon Urology Institute
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Ledende efterforsker:
- Bryan Mehlhaff
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Kontakt:
- Maxim Dimarco
- E-mail: mdimarco@oregonurology.com
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19111
- Rekruttering
- Fox Chase Cancer Center
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Kontakt:
- Candice Schewbel
- Telefonnummer: 215-728-3075
- E-mail: candice.schwebel@fccc.edu
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Ledende efterforsker:
- Matthew Zibelman
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South Carolina
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Myrtle Beach, South Carolina, Forenede Stater, 29572
- Rekruttering
- Carolina Urologic Research Center
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Ledende efterforsker:
- Neal D Shore
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Kontakt:
- Rebecca Floyd
- Telefonnummer: 843-839-1679
- E-mail: rebecca.floyd@startresearch.com
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Texas
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Dallas, Texas, Forenede Stater, 75251
- Rekruttering
- Texas Oncology
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Kontakt:
- Marian Heaven
- Telefonnummer: 512-427-9467
- E-mail: marian.heaven@usoncology.com
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Ledende efterforsker:
- Michael P Herman
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San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- Urology San Antonio
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Ledende efterforsker:
- Daniel Saltzstein
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Kontakt:
- Sandra Davila
- E-mail: sandra.davila@usa-clinicaltrials.com
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Utah
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Murray, Utah, Forenede Stater, 84107
- Rekruttering
- Utah Intermountain Medical Center
-
Ledende efterforsker:
- David Gill
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Kontakt:
- Becky Arroyo
- E-mail: becky.arroyo@imail.org
-
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Virginia Cancer Specialists
-
Ledende efterforsker:
- Gregory Scott Sibley
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Kontakt:
- Kristi Ben-Barka
- E-mail: kristi.ben-barka@usoncology.com
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Roanoke, Virginia, Forenede Stater, 24014
- Rekruttering
- Onco Hemato Asso of SW Virginia
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Ledende efterforsker:
- David Buck
-
Kontakt:
- Natasha Holt
- Telefonnummer: 540-774-8660
- E-mail: natasha.holt@usoncology.com
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Washington
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Seattle, Washington, Forenede Stater, 98109-1024
- Rekruttering
- Fred Hutchinson Cancer Research Center
-
Kontakt:
- Brianna Woo
- E-mail: bwoo@fredhutch.org
-
Ledende efterforsker:
- Ruben Raychaudhuri
-
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Rekruttering
- Medical College Of Wisconsin
-
Ledende efterforsker:
- Deepak Kilari
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Kontakt:
- Nadia Thomas
- E-mail: nathomas@mcw.edu
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Hong Kong, Hong Kong, 999077
- Rekruttering
- Novartis Investigative Site
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-
-
-
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Beersheba, Israel, 8457108
- Rekruttering
- Novartis Investigative Site
-
Haifa, Israel, 3109601
- Rekruttering
- Novartis Investigative Site
-
Jerusalem, Israel, 9112001
- Rekruttering
- Novartis Investigative Site
-
Petah Tikva, Israel, 4941492
- Rekruttering
- Novartis Investigative Site
-
Ramat Gan, Israel, 5265601
- Rekruttering
- Novartis Investigative Site
-
Tel Aviv, Israel, 6423906
- Rekruttering
- Novartis Investigative Site
-
-
-
-
-
Chiba, Japan, 2608717
- Rekruttering
- Novartis Investigative Site
-
Fukuoka, Japan, 8128582
- Rekruttering
- Novartis Investigative Site
-
Fukuoka, Japan, 8110213
- Rekruttering
- Novartis Investigative Site
-
Fukuoka, Japan, 8120033
- Rekruttering
- Novartis Investigative Site
-
Fukushima, Japan, 9601295
- Rekruttering
- Novartis Investigative Site
-
Ishikawa, Japan, 9208641
- Rekruttering
- Novartis Investigative Site
-
Kyoto, Japan, 6068507
- Rekruttering
- Novartis Investigative Site
-
-
Chiba
-
Kashiwa, Chiba, Japan, 2778577
- Rekruttering
- Novartis Investigative Site
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 0608648
- Rekruttering
- Novartis Investigative Site
-
-
Hyōgo
-
Kobe, Hyōgo, Japan, 6500047
- Rekruttering
- Novartis Investigative Site
-
-
Kanagawa
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Yokohama, Kanagawa, Japan, 2360004
- Rekruttering
- Novartis Investigative Site
-
-
-
-
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Beijing, Kina, 100036
- Rekruttering
- Novartis Investigative Site
-
Beijing, Kina, 100034
- Rekruttering
- Novartis Investigative Site
-
Guangzhou, Kina, 510060
- Rekruttering
- Novartis Investigative Site
-
Shanghai, Kina, 200025
- Rekruttering
- Novartis Investigative Site
-
Shanghai, Kina, 200032
- Rekruttering
- Novartis Investigative Site
-
Tianjin, Kina, 300480
- Rekruttering
- Novartis Investigative Site
-
Tianjin, Kina, 300300
- Rekruttering
- Novartis Investigative Site
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350025
- Rekruttering
- Novartis Investigative Site
-
-
Hubei
-
Wuhan, Hubei, Kina, 430022
- Rekruttering
- Novartis Investigative Site
-
Wuhan, Hubei, Kina, 430030
- Rekruttering
- Novartis Investigative Site
-
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Jiangsu
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Nanjing, Jiangsu, Kina, 210006
- Rekruttering
- Novartis Investigative Site
-
Nanjing, Jiangsu, Kina, 210029
- Rekruttering
- Novartis Investigative Site
-
-
Liaoning
-
Shenyang, Liaoning, Kina, 110011
- Rekruttering
- Novartis Investigative Site
-
-
Shanxi
-
Xian, Shanxi, Kina, 710032
- Rekruttering
- Novartis Investigative Site
-
Xian, Shanxi, Kina, 710061
- Rekruttering
- Novartis Investigative Site
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610041
- Rekruttering
- Novartis Investigative Site
-
-
-
-
Kuala Lumpur
-
Putrajaya, Kuala Lumpur, Malaysia, 62250
- Rekruttering
- Novartis Investigative Site
-
-
Selangor
-
Petaling Jaya, Selangor, Malaysia, 46050
- Rekruttering
- Novartis Investigative Site
-
Petaling Jaya, Selangor, Malaysia, 46150
- Rekruttering
- Novartis Investigative Site
-
-
-
-
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Huxquilucan, Mexico, 52763
- Rekruttering
- Novartis Investigative Site
-
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Mexico City
-
Mexico City, Mexico City, Mexico, 14050
- Rekruttering
- Novartis Investigative Site
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-
-
-
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Basel, Schweiz, 4031
- Rekruttering
- Novartis Investigative Site
-
Bellinzona, Schweiz, 6500
- Rekruttering
- Novartis Investigative Site
-
Bern, Schweiz, 3010
- Rekruttering
- Novartis Investigative Site
-
-
-
-
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Singapore, Singapore, 119228
- Rekruttering
- Novartis Investigative Site
-
Singapore, Singapore, 168583
- Rekruttering
- Novartis Investigative Site
-
Singapore, Singapore, 258499
- Rekruttering
- Novartis Investigative Site
-
-
-
-
-
Seoul, Sydkorea, 03080
- Rekruttering
- Novartis Investigative Site
-
Seoul, Sydkorea, 05505
- Rekruttering
- Novartis Investigative Site
-
Seoul, Sydkorea, 06591
- Rekruttering
- Novartis Investigative Site
-
Seoul, Sydkorea, 03722
- Rekruttering
- Novartis Investigative Site
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-
-
-
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Taipei, Taiwan, 10002
- Rekruttering
- Novartis Investigative Site
-
Taipei, Taiwan, 11217
- Rekruttering
- Novartis Investigative Site
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Taipei, Taiwan, 103616
- Rekruttering
- Novartis Investigative Site
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Taoyuan, Taiwan, 33305
- Rekruttering
- Novartis Investigative Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria: ∙
- adults ≥ 18 years of age.
- ECOG performance status of 0 to 2.
- histopathological and/or cytological confirmation of adenocarcinoma of the prostate.
- PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed,
- castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
- Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy.
- ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
- eGFR as requested by the sponsor
Exclusion Criteria:
- Any investigational agents within 28 days prior to the day of randomization.
- Any 225Ac-based investigational compound used prior to the day of randomization.
- Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
- Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)
- Baseline xerostomia ≥ Grade 2 by CTCAE v.5
- History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 2 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed).
Other protocol-defined inclusion/exclusion criteria may apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Phase II: AAA817 Dose B
AAA817 will be given for a number of cycles; a cycle = 8 weeks |
The investigational treatment is AAA817
Andre navne:
Investigational treatment is the Dose B of AAA817
Andre navne:
|
|
Aktiv komparator: Phase III: Investigator's choice of SoC
Participants will be given Standard of Care (SOC) treatment per Investigator's choice. |
The control treatment in Phase III is investigator's choice of SoC |
|
Eksperimentel: Phase II: AAA817 Dose A
AAA817 Dose A will be given for a number of cycles: a cycle = 8 weeks |
The investigational treatment is AAA817
Andre navne:
Investigational treatment is the Dose B of AAA817
Andre navne:
|
|
Eksperimentel: Phase III: Recommended Phase 3 Dose of AAA817
Rp3D of AAA817 will be given for a number of cycles; a cycle = 8 weeks |
The investigational treatment is AAA817
Andre navne:
Investigational treatment is the Dose B of AAA817
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Biochemical response rate (Phase II)
Tidsramme: from date of randomization up to approximately 24 months
|
Biochemical response rate as defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second measurement |
from date of randomization up to approximately 24 months
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs), and deaths - Phase II
Tidsramme: from day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later
|
Safety defined as the type, incidence and severity of AEs and SAEs, and deaths |
from day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later
|
|
Tolerability of the proposed dose of AAA817- Phase II
Tidsramme: From on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817
|
Percentage of participants who experienced Dose interruptions, reductions, discontinuation, dose intensity and duration of exposure |
From on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817
|
|
Radiographic progression-free survival (rPFS)- Phase III
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis |
from date of randomization up to approximately 24 months
|
|
Overall survival (OS)- Phase III
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of participants who are alive or who are lost to follow-up at the time of analysis |
from date of randomization up to approximately 24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Radiographic progression-free survival (rPFS)- Phase II
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis |
from date of randomization up to approximately 24 months
|
|
Progression free survival (PFS)- Phase II
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of Participants meeting Progression Free Survival |
from date of randomization up to approximately 24 months
|
|
Overall response rate (ORR)- Phase II
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) |
from date of randomization up to approximately 24 months
|
|
Disease control rate (DCR)- Phase II
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of participants with BOR of CR, PR, stable disease (SD) or non-CR/non-PD |
from date of randomization up to approximately 24 months
|
|
Overall survival (OS)- Phase II
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of participants who are alive or who are lost to follow-up at the analysis data cut-off |
from date of randomization up to approximately 24 months
|
|
Progression free survival (PFS) -Phase III
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of participants with PFS -defined as the time from date of randomization to first documented progression |
from date of randomization up to approximately 24 months
|
|
Overall response rate (ORR)- Phase III
Tidsramme: from date of randomization up to approximately 24 months
|
ORR is defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) |
from date of randomization up to approximately 24 months
|
|
Disease control rate (DCR) -Phase III
Tidsramme: from date of randomization up to approximately 24 months
|
DCR is defined as the percentage of participants with BOR of confirmed CR, PR, stable disease (SD) or Non-CR/Non progressive disease (PD) |
from date of randomization up to approximately 24 months
|
|
Duration of response (DoR)- Phase III
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of participants with confirmed DoR defined as duration of time between the date of first documented response (CR or PR) and progression or death due to any cause, whichever occurs first. |
from date of randomization up to approximately 24 months
|
|
Time to first radiographic soft tissue progression (TTSTP)- Phase III
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of participants with confirmed first radiographic progression in soft tissue |
from date of randomization up to approximately 24 months
|
|
First symptomatic skeletal event (TTSSE)_Phase III
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of participants with confirmed skeletal event is defined as new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, or requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurs first |
from date of randomization up to approximately 24 months
|
|
Prostate specific antigen (PSA) response -Phase III
Tidsramme: from date of randomization up to approximately 24 months
|
PSA50 is defined as the percentage of participants who achieved a confirmed ≥ 50% decrease from baseline |
from date of randomization up to approximately 24 months
|
|
Patient reported disease related symptoms and health-related quality of life (HRQoL): Phase III
Tidsramme: from date of randomization up to approximately 24 months
|
Percentage of participants who had a Change from baseline on FACT-P Prostate Cancer Subscale (PCS) |
from date of randomization up to approximately 24 months
|
|
Time to worsening on the Worst Pain: Phase III
Tidsramme: from date of randomization up to approximately 24 months
|
Time to worsening on the Worst Pain defined as the time from randomization to the first occurrence of worsening on the Worst Pain item (brief pain inventory - short form (BPI-SF)) of at least 30% of baseline or minimum of 2 points increase from baseline, or death due to any cause, whichever occurs first. BPI-SF is a self-reported questionnaire to evaluate pain intensity (severity) and impact of pain on the participant's daily functioning (interference). |
from date of randomization up to approximately 24 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. februar 2025
Primær færdiggørelse (Anslået)
27. juni 2028
Studieafslutning (Anslået)
19. juli 2033
Datoer for studieregistrering
Først indsendt
17. december 2024
Først indsendt, der opfyldte QC-kriterier
16. januar 2025
Først opslået (Faktiske)
17. januar 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CAAA817A12201
- 2024-512342-42-00 (Anden identifikator: EU CTIS)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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