Étude de phase III comparant AAA817 + ARPI versus standard de soins chez les participants adultes avec MCRPC PSMA positif (AcTFirst)
Une étude randomisée de phase III, ouverte, multicentrique, comparant AAA817 + ARPI versus standard de soins chez les participants adultes atteints de cancer de la prostate résistant à la castration métastatique PSMA positive
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Novartis Pharmaceuticals
- Numéro de téléphone: 1-888-669-6682
- E-mail: novartis.email@novartis.com
Sauvegarde des contacts de l'étude
- Nom: Novartis Pharmaceuticals
- Numéro de téléphone: +41613241111
Lieux d'étude
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Adelaide, Australie, 5000
- Recrutement
- Novartis Investigative Site
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New South Wales
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Darlinghurst, New South Wales, Australie, 2010
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- Novartis Investigative Site
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South Australia
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Adelaide, South Australia, Australie, 5000
- Recrutement
- Novartis Investigative Site
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Victoria
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Malvern, Victoria, Australie, 3144
- Recrutement
- Novartis Investigative Site
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Western Australia
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Murdoch, Western Australia, Australie, 6150
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- Novartis Investigative Site
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São Paulo
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São Paulo, São Paulo, Brésil, 01308-050
- Recrutement
- Novartis Investigative Site
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São Paulo, São Paulo, Brésil, 05652-000
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- Novartis Investigative Site
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Beijing, Chine, 100036
- Recrutement
- Novartis Investigative Site
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Beijing, Chine, 100034
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- Novartis Investigative Site
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Guangzhou, Chine, 510060
- Recrutement
- Novartis Investigative Site
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Shanghai, Chine, 200025
- Recrutement
- Novartis Investigative Site
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Shanghai, Chine, 200032
- Recrutement
- Novartis Investigative Site
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Shanghai, Chine, 200001
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- Novartis Investigative Site
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Tianjin, Chine, 300480
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- Novartis Investigative Site
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Tianjin, Chine, 300300
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- Novartis Investigative Site
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Fujian
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Fuzhou, Fujian, Chine, 350025
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- Novartis Investigative Site
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Guangdong
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Guangzhou, Guangdong, Chine, 510120
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- Novartis Investigative Site
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Guangzhou, Guangdong, Chine, 510632
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- Novartis Investigative Site
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Hubei
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Wuhan, Hubei, Chine, 430022
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- Novartis Investigative Site
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Wuhan, Hubei, Chine, 430030
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- Novartis Investigative Site
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Jiangsu
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Nanjing, Jiangsu, Chine, 210006
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- Novartis Investigative Site
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Nanjing, Jiangsu, Chine, 210029
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- Novartis Investigative Site
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Liaoning
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Shenyang, Liaoning, Chine, 110011
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- Novartis Investigative Site
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Sichuan
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Chengdu, Sichuan, Chine, 610041
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- Novartis Investigative Site
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310022
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- Novartis Investigative Site
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Hangzhou, Zhejiang, Chine, 310007
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- Novartis Investigative Site
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Seoul, Corée du Sud, 03080
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- Novartis Investigative Site
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Seoul, Corée du Sud, 05505
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- Novartis Investigative Site
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Seoul, Corée du Sud, 06591
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- Novartis Investigative Site
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Seoul, Corée du Sud, 03722
- Recrutement
- Novartis Investigative Site
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Seoul, Corée du Sud, 06351
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- Novartis Investigative Site
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Seoul, Corée du Sud, 01812
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- Novartis Investigative Site
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Hong Kong, Hong Kong, 999077
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- Novartis Investigative Site
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Haryana
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Gurgaon, Haryana, Inde, 122002
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- Novartis Investigative Site
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Karnataka
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Bengaluru, Karnataka, Inde, 560066
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- Novartis Investigative Site
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Maharashtra
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Mumbai, Maharashtra, Inde, 400012
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- Novartis Investigative Site
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Chiba, Japon, 2608717
- Recrutement
- Novartis Investigative Site
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Fukuoka, Japon, 8128582
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- Novartis Investigative Site
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Fukuoka, Japon, 8110213
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- Novartis Investigative Site
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Fukuoka, Japon, 8120033
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- Novartis Investigative Site
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Fukushima, Japon, 9601295
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- Novartis Investigative Site
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Hiroshima, Japon, 7348551
- Recrutement
- Novartis Investigative Site
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Kyoto, Japon, 6068507
- Recrutement
- Novartis Investigative Site
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Aichi-ken
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Nagoya, Aichi-ken, Japon, 4668560
- Recrutement
- Novartis Investigative Site
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Hokkaido
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Sapporo, Hokkaido, Japon, 0608648
- Recrutement
- Novartis Investigative Site
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Hyōgo
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Kobe, Hyōgo, Japon, 6500047
- Recrutement
- Novartis Investigative Site
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Kobe, Hyōgo, Japon, 6500017
- Recrutement
- Novartis Investigative Site
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Kanagawa
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Kamakura, Kanagawa, Japon, 2478533
- Recrutement
- Novartis Investigative Site
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Yokohama, Kanagawa, Japon, 2360004
- Recrutement
- Novartis Investigative Site
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Kumamoto
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Kumamoto, Kumamoto, Japon, 8608556
- Recrutement
- Novartis Investigative Site
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Tokyo
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Chuo Ku, Tokyo, Japon, 1040045
- Recrutement
- Novartis Investigative Site
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Mexico City, Mexique, 03330
- Recrutement
- Novartis Investigative Site
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London, Royaume-Uni, EC1A 7BE
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Oxfordshire
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Oxford, Oxfordshire, Royaume-Uni, OX4 6LB
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- Novartis Investigative Site
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Surrey
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Sutton, Surrey, Royaume-Uni, SM2 5PT
- Recrutement
- Novartis Investigative Site
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Windsor, Surrey, Royaume-Uni, SL4 3HD
- Recrutement
- Novartis Investigative Site
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Singapore, Singapour, 169608
- Recrutement
- Novartis Investigative Site
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Singapore, Singapour, 119074
- Recrutement
- Novartis Investigative Site
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Singapore, Singapour, 168583
- Recrutement
- Novartis Investigative Site
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Kaohsiung City, Taïwan, 833
- Recrutement
- Novartis Investigative Site
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Taichung, Taïwan, 407219
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- Novartis Investigative Site
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Tainan, Taïwan, 704302
- Recrutement
- Novartis Investigative Site
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Taipei, Taïwan, 10002
- Recrutement
- Novartis Investigative Site
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Taoyuan, Taïwan, 33305
- Recrutement
- Novartis Investigative Site
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Alabama
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Homewood, Alabama, États-Unis, 35209
- Recrutement
- Urology Centers Of Alabama Pc
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Contact:
- Meredith Sharpton
- E-mail: msharpton@urologyal.com
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Chercheur principal:
- Bryant Poole
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Arizona
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Tucson, Arizona, États-Unis, 85724
- Recrutement
- University of Arizona
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Contact:
- Jeanette Cardenas
- Numéro de téléphone: 520-626-2340
- E-mail: serranoj@arizona.edu
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Chercheur principal:
- Bital Savir-Baruch
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California
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Orange, California, États-Unis, 92868
- Recrutement
- Univ Cali Irvine ALS Neuromuscular
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Chercheur principal:
- Arash Rezazadeh Kalebasty
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Contact:
- Amanda Macaraeg
- Numéro de téléphone: 714-456-2332
- E-mail: macaraeg@hs.uci.edu
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Palo Alto, California, États-Unis, 94304
- Recrutement
- Stanford University Medical Center
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Chercheur principal:
- Hong Song
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Contact:
- Tiffany Chen
- E-mail: tiff1221@stanford.edu
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Santa Barbara, California, États-Unis, 93105
- Recrutement
- Sansum Clinic
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Contact:
- Megan Martinez
- Numéro de téléphone: 805-563-5800
- E-mail: megan.martinez@sutterhealth.or
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Chercheur principal:
- Mukul Gupta
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Colorado
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Denver, Colorado, États-Unis, 80218
- Recrutement
- Rocky Mountain Cancer Centers
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Chercheur principal:
- Allen Cohn
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Contact:
- Bethany Glatthar
- Numéro de téléphone: 303-839-6530
- E-mail: Bethany.Glatthar@usoncology.com
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Florida
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Fort Myers, Florida, États-Unis, 33901
- Recrutement
- Florida Cancer Specialists
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Chercheur principal:
- Bradford Perez
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Contact:
- Julie Kara
- E-mail: jkara@flcancer.com
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Miami, Florida, États-Unis, 33173
- Recrutement
- Baptist Health South
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Chercheur principal:
- Rohan Garje
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Contact:
- Leslie Castaneda
- E-mail: leslie.castaneda@baptisthealth.net
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Orlando, Florida, États-Unis, 32804
- Recrutement
- AdventHealth
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Chercheur principal:
- Ravi Shridhar
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Contact:
- Joseph Guzzo
- Numéro de téléphone: 407-303-3235
- E-mail: joseph.guzzo@adventhealth.com
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Georgia
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Athens, Georgia, États-Unis, 30607
- Recrutement
- University Cancer and Blood Center LLC
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Contact:
- Mary Egan
- Numéro de téléphone: 706-353-2990
- E-mail: mary.egan@universitycancer.com
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Chercheur principal:
- Gordon Schoenfeld
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Recrutement
- Northwestern University
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Contact:
- Rachel Hanna Springsdorf
- Numéro de téléphone: +1 312 695 1382
- E-mail: rachelspringsdorf@northwestern.edu
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Chercheur principal:
- Maha Hussain
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Chicago, Illinois, États-Unis, 60612
- Recrutement
- University of Illinois Cancer Center at Chicago
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Chercheur principal:
- Natalie Reizine
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Contact:
- Ethan Gu
- Numéro de téléphone: 312-413-2746
- E-mail: egu3@uic.edu
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Iowa
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Iowa City, Iowa, États-Unis, 52242
- Recrutement
- Univ Of Iowa Hospitals And Clinics
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Contact:
- Kellie Bodeker
- E-mail: kellie-bodeker@uiowa.edu
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Chercheur principal:
- Kristin Plichta
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- Recrutement
- University of Kansas Hospital
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Chercheur principal:
- Xinglei Shen
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Contact:
- Collin Bruey
- E-mail: cbruey@kumc.edu
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Louisiana
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Metairie, Louisiana, États-Unis, 70006
- Recrutement
- East Jefferson Hospital
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Chercheur principal:
- Alton Oliver Sartor
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Contact:
- Alexandra Lieberman
- E-mail: alexandra.lieberman@lcmchealth.org
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Maine
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Scarborough, Maine, États-Unis, 04074
- Recrutement
- New England Cancer Specialists
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Contact:
- Abigail Berard
- E-mail: berara@newecs.org
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Chercheur principal:
- Christian Anton Thomas
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Recrutement
- Johns Hopkins Hospital
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Chercheur principal:
- Ana Kiess
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Contact:
- Noura Radwan
- E-mail: nradwan1@jhmi.edu
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Recrutement
- Dana Farber Cancer Institute
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Chercheur principal:
- Xiao Wei
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Contact:
- Amanda Lilienfeld
- E-mail: amanda_lilienfeld@dfci.harvard.edu
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Boston, Massachusetts, États-Unis, 02215
- Recrutement
- Beth Israel Deaconess Med Center
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Chercheur principal:
- Glenn Bubley
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Contact:
- Katerina von Helms
- Numéro de téléphone: 617-667-7000
- E-mail: kvonhelm@bidmc.harvard.edu
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Michigan
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Detroit, Michigan, États-Unis, 48201
- Recrutement
- Karmanos Cancer Institute
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Contact:
- Kimberlee Dobson
- Numéro de téléphone: 313-576-9454
- E-mail: dobsonk@karmanos.org
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Chercheur principal:
- Nitin Vaishampayan
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Recrutement
- Wash U School of Medicine
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Chercheur principal:
- Jeff Michalski
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Contact:
- Collin Welch
- E-mail: c.welch@wustl.edu
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Nebraska
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Omaha, Nebraska, États-Unis, 68154
- Recrutement
- Nebraska Cancer Specialists
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Contact:
- Marlene Bridwell
- E-mail: mbridwell@nebraskacancer.com
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Chercheur principal:
- Samuel Mehr
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New Jersey
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East Brunswick, New Jersey, États-Unis, 08816
- Recrutement
- Astera Cancer Center
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Contact:
- Allison Cabinian
- E-mail: allison.cabinian@asterahealthcare.org
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Chercheur principal:
- Phillip D Reid
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Voorhees Township, New Jersey, États-Unis, 08043
- Recrutement
- New Jersey Urology LLC
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Contact:
- Gabriela Mercado
- Numéro de téléphone: 856-673-1613
- E-mail: gmercado3@nj-urology.com
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Chercheur principal:
- Gordon Brown
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87109
- Recrutement
- New Mexico Oncology Hematology
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Contact:
- Kimberly Demos
- Numéro de téléphone: +1 505 822 3869#3867
- E-mail: kimberlyd@nmohc.com
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Chercheur principal:
- Gregg Franklin
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New York
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Cooperstown, New York, États-Unis, 13326
- Recrutement
- Bassett Medical Center
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Contact:
- Peggy Cross
- E-mail: peggy.cross@bassett.org
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Chercheur principal:
- Timothy Korytko
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New York, New York, États-Unis, 10021
- Recrutement
- Weill Cornell Medicine NY-Presb
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Chercheur principal:
- Scott Tagawa
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Contact:
- Sarah Yuan
- Numéro de téléphone: 646-962-2535
- E-mail: say7008@med.cornell.edu
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Rochester, New York, États-Unis, 14642
- Recrutement
- University of Rochester Medical Ctr
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Contact:
- Therese Smudzin
- E-mail: Therese_Smudzin@urmc.rochester.edu
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Chercheur principal:
- Haoming Carl Qiu
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Syracuse, New York, États-Unis, 13210
- Recrutement
- Associated Med Professionals of NY
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Chercheur principal:
- Steven Finkelstein
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Contact:
- Nathan Forrest
- E-mail: nathan.forrest@ampofny.com
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The Bronx, New York, États-Unis, 10461
- Recrutement
- Montefiore Medical Center
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Chercheur principal:
- Benjamin A Gartrell
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Contact:
- Tahrima Chowdhury
- Numéro de téléphone: 718-920-2680
- E-mail: tahchowdhu@montefiore.org
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Ohio
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Cincinnati, Ohio, États-Unis, 45212
- Recrutement
- Urology Group - Solaris Network
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Contact:
- William Corbett
- E-mail: wcorbett@urologygroup.com
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Chercheur principal:
- Marc Pliskin
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Gahanna, Ohio, États-Unis, 43230
- Recrutement
- Central Ohio Urology Group
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Chercheur principal:
- Benjamin Martin
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Contact:
- Sam Carey
- E-mail: Sam.Carey@centralohiourology.com
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Recrutement
- MUSC Hollings Cancer Center
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Chercheur principal:
- Kevin Becker
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Contact:
- Alex Jones
- E-mail: joalex@musc.edu
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Myrtle Beach, South Carolina, États-Unis, 29572
- Recrutement
- Carolina Urologic Research Center
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Chercheur principal:
- Neal D Shore
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Contact:
- Rebecca Floyd
- Numéro de téléphone: 843-839-1679
- E-mail: rebecca.floyd@startresearch.com
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37404
- Recrutement
- Tennessee Oncology PLLC
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Chercheur principal:
- Katy Beckermann
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Contact:
- Mercedes Bruce
- E-mail: mbruce@tnonc.com
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Texas
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Lakeway, Texas, États-Unis, 78738
- Recrutement
- Urology Austin
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Chercheur principal:
- Brian Mazzarella
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Contact:
- Christine Chau
- E-mail: christine.chau@urologyaustin.com
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San Antonio, Texas, États-Unis, 78229
- Recrutement
- Urology San Antonio
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Chercheur principal:
- Daniel Saltzstein
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Contact:
- Sandra Davila
- E-mail: sandra.davila@usa-clinicaltrials.com
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The Woodlands, Texas, États-Unis, 77384
- Recrutement
- Woodlands Cancer Institute American Oncology Partners
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Contact:
- Brittany Rogers
- E-mail: brittany.rogers@aoncology.com
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Chercheur principal:
- Jason Berilgen
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Washington
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Seattle, Washington, États-Unis, 98122-4379
- Recrutement
- Swedish Medical Center
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Chercheur principal:
- Song Zhao
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Contact:
- Brianna McNealley
- Numéro de téléphone: 855-922-6237
- E-mail: brianna.mcnealley@swedish.org
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Tacoma, Washington, États-Unis, 98405
- Recrutement
- Northwest Medical Specialties
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Chercheur principal:
- Li Zhang
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Contact:
- Patricia Walsh
- E-mail: pwalsh@nwmsonline.com
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West Virginia
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Morgantown, West Virginia, États-Unis, 26506
- Recrutement
- West Virginia University Hospital
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Contact:
- Nina Moore
- E-mail: nina.moore@hsc.wvu.edu
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Chercheur principal:
- Raheel Siddiqui
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Recrutement
- Medical College of Wisconsin
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Chercheur principal:
- Deepak Kilari
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Contact:
- Mariah Ziegler
- Numéro de téléphone: 414-805-5249
- E-mail: mziegler@mcw.edu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Key Inclusion Criteria:
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Signed informed consent must be obtained prior to participation in the study.
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Participants must be adults ≥ 18 years of age.
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Participants must have an ECOG performance status of 0 to 2.
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Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.
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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.
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Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).
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Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.
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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:
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Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, [177Lu]Lu-PSMA, [177Lu]-DOTA, or Radium- 223.)
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Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).
- Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.
Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.
Other protocol-defined inclusion/exclusion criteria may apply.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Investigational Arm: AAA817+ARPI (enzalutamide or abiraterone)
Participants will receive AAA817 infusion directly into a vein with ARPIs. |
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.
Autres noms:
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.
Autres noms:
|
|
Expérimental: Investigational Arm: AAA817
Participants will receive AAA817 infusion directly into a vein. |
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.
Autres noms:
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Comparateur actif: 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. |
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.
Autres noms:
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).
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Radiographic Progression Free Survival (rPFS)
Délai: 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.
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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.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall Survival (OS) (Key Secondary Endpoint)
Délai: From the date of randomization to the date of death due to any cause, assessed up to approximately 40 months.
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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.
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Radiographic Progression Free Survival by by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 (Key Secondary)
Délai: 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.
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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.
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Overall Survival in participants with PSMA-positive mCRPC treated with another ARPI. (Key Secondary)
Délai: From the date of randomization to the date of death due to any cause.
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Time to death due to any cause. |
From the date of randomization to the date of death due to any cause.
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rPFS in participants treated with AAA817
Délai: 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.
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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.
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Progression Free Survival (PFS)
Délai: 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.
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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.
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Progression Free Survival (PFS2)
Délai: 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.
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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.
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Overall Response Rate (ORR)
Délai: 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.
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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.
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Disease Control Rate (DCR)
Délai: 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.
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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.
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Duration of Response (DoR)
Délai: 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.
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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.
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Time to first radiographic soft tissue progression (TTSTP)
Délai: 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.
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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.
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Time to first symptomatic skeletal event (TTSSE)
Délai: 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.
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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.
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Prostate specific antigen response (PSA50 and PSA90)
Délai: From the date of randomization to the date of safety follow up, assessed up to approximately 40.0 months.
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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.
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Time-concentration profiles and PK parameters of AAA817
Délai: From Cycle 1 Day 1 up to approximately cycle 5 days 11 (each cycle is 8 weeks).
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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).
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Change from baseline on FACT-P Prostate Cancer Subscale (PCS)
Délai: 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.
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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.
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Time to worsening on the Worst Pain
Délai: 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.
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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.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- CPRCm
- PSMA
- Thérapie par radioligands
- RLT
- Cancer de la prostate métastatique résistant à la castration
- Taxane
- ARPI
- AAA617
- PSMA positif
- AAA817
- Cancer de la prostate résistant à la castration métastatique positive
- [225AC] AC-PSMA-617
- Inhibiteur de la voie des récepteurs des androgènes
- Actif
- [177Lu]Lu-PSMA-617
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Tumeurs génitales, homme
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies génitales, sexe masculin
- Maladies de la prostate
- Maladies urogénitales masculines
- Tumeurs prostatiques
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Qualité des soins de santé
- Indicateurs de qualité, soins de santé
- Standard de soins
- abiraterone
- enzalutamide
- (225) AC-PSMA-617
Autres numéros d'identification d'étude
- CAAA817B12301
- 2024-512340-32 (Identificateur de registre: EU CTIS)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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
Informations sur les médicaments et les dispositifs, documents d'étude
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