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PSMA 양성 MCRPC와 성인 참가자의 AAA817+ARPI와 표준 치료를 비교 한 III 상 연구 (AcTFirst)

2026년 10월 14일 업데이트: Novartis Pharmaceuticals

PSMA 양성 전이 캐스 스트레이트 내성 전립선 암을 가진 성인 참가자의 AA817+ARPI 대 치료 표준 치료를 비교 한 III 상, 오픈 라벨, 다중 센터, 무작위 연구.

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

940

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Novartis Pharmaceuticals
  • 전화번호: +41613241111

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

남성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Investigational Arm: AAA817+ARPI (enzalutamide or abiraterone)

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

다른 이름들:
  • [225Ac]Ac-PSMA-617
의약품: 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.

다른 이름들:
  • Enzalutamide 또는 Abiraterone
실험적: Investigational Arm: AAA817

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

다른 이름들:
  • [225Ac]Ac-PSMA-617
활성 비교기: 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.
의약품: 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.

다른 이름들:
  • Enzalutamide 또는 Abiraterone
의약품: 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).

다른 이름들:
  • Arpi Enzalutamide
  • ARPI ABIRATERONE
  • 도세탁셀의 탁산 기반 화학 요법
  • 카지 티탁셀의 탁산 기반 화학 요법
  • [177Lu]Lu-PSMA-617 (AAA617)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Radiographic Progression Free Survival (rPFS)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS) (Key Secondary Endpoint)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

수사관

  • 연구 책임자: Novartis Pharmaceuticals, Novartis Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 7월 1일

기본 완료 (추정된)

2028년 9월 29일

연구 완료 (추정된)

2032년 11월 4일

연구 등록 날짜

최초 제출

2025년 2월 18일

QC 기준을 충족하는 최초 제출

2025년 2월 26일

처음 게시됨 (실제)

2025년 3월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 14일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CAAA817B12301
  • 2024-512340-32 (레지스트리 식별자: EU CTIS)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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구독하다