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一项开放标签研究，比较镥 (177Lu) Vipivotide Tetraxetan 与 PSMA 阳性 OMPC 中的观察结果。 (PSMA-DC)

2026年10月20日 更新者：Novartis Pharmaceuticals

一项国际、前瞻性、开放标签、多中心、随机 III 期研究，比较镥 (177Lu) Vipivotide Tetraxetan (AAA617) 与观察治疗对前列腺特异性膜抗原 (PSMA) 阳性寡转移的成年男性患者延迟去势或疾病复发的影响前列腺癌 (OMPC)

The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

All participants will be assessed for eligibility and will undergo baseline disease assessments including a mandatory gallium (68Ga) gozetotide (also known as [68Ga]Ga-PSMA-11) or piflufolastat (18F) ( also known as[18F]DCFPyL) PET/CT scan and CI (i.e., CT/MRI and bone scans).

Piflufolastat (18F) PET/CT scan will be performed in countries where it is approved.

Stereotactic Body Radiation Therapy (SBRT) will be administered to all metastatic Prostate Cancer (PC) lesions after randomization and before the start of treatment with AAA617 or observation.

  • The duration of SBRT procedures is approximately 3 weeks.
  • For participants randomized to the investigational arm (AAA617), the treatment duration will be up to 4 cycles of AAA617. For participants randomized to the control arm (observation) the treatment duration will end at the last fraction of SBRT administration.
  • The visit frequency will be every week 1 and 3 of each of the 4 cycles and every 16 weeks thereafter (for both arms) until first event of disease progression (RECIST 1.1)
  • The study duration is approximately 7.5 years.

研究类型

介入性

注册 (估计的)

450

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
      • Beijing、中国、100036
        • 招聘中
        • Novartis Investigative Site
      • Guangzhou、中国、510060
        • 招聘中
        • Novartis Investigative Site
      • Shanghai、中国、200001
        • 招聘中
        • Novartis Investigative Site
  • 以色列
      • Beersheba、以色列、8457108
        • 招聘中
        • Novartis Investigative Site
      • Haifa、以色列、3109601
        • 招聘中
        • Novartis Investigative Site
      • Jerusalem、以色列、9112001
        • 招聘中
        • Novartis Investigative Site
      • Petah Tikva、以色列、4941492
        • 招聘中
        • Novartis Investigative Site
      • Tel Aviv、以色列、6423906
        • 招聘中
        • Novartis Investigative Site
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 5G2
        • 招聘中
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 2Y9
        • 招聘中
        • Novartis Investigative Site
    • Ontario
      • London、Ontario、加拿大、N6A 4G5
        • 招聘中
        • Novartis Investigative Site
      • Ottawa、Ontario、加拿大、K1H 8L6
        • 招聘中
        • Novartis Investigative Site
      • Toronto、Ontario、加拿大、M5G 2M9
        • 招聘中
        • Novartis Investigative Site
    • Quebec
      • Montreal、Quebec、加拿大、H3T 1E2
        • 招聘中
        • Novartis Investigative Site
      • Montreal、Quebec、加拿大、H2X 1R9
        • 招聘中
        • Novartis Investigative Site
      • Québec、Quebec、加拿大、G1J 1Z4
        • 招聘中
        • Novartis Investigative Site
  • 匈牙利
      • Budapest、匈牙利、1122
        • 招聘中
        • Novartis Investigative Site
      • Budapest、匈牙利、1083
        • 招聘中
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen、Hajdu Bihar Megye、匈牙利、4032
        • 招聘中
        • Novartis Investigative Site
  • 台湾
      • Taipei、台湾、10002
        • 招聘中
        • Novartis Investigative Site
      • Taipei、台湾、11217
        • 招聘中
        • Novartis Investigative Site
      • Taipei、台湾、103616
        • 招聘中
        • Novartis Investigative Site
      • Taoyuan、台湾、33305
        • 招聘中
        • Novartis Investigative Site
  • 哥伦比亚
      • Bogotá、哥伦比亚、110131
        • 招聘中
        • Novartis Investigative Site
    • Cundinamarca
      • Bogota、Cundinamarca、哥伦比亚、110111
        • 招聘中
        • Novartis Investigative Site
  • 墨西哥
      • Huxquilucan、墨西哥、52763
        • 招聘中
        • Novartis Investigative Site
    • Mexico City
      • Mexico City、Mexico City、墨西哥、14050
        • 招聘中
        • Novartis Investigative Site
  • 奥地利
      • Linz、奥地利、4020
        • 招聘中
        • Novartis Investigative Site
      • Vienna、奥地利、1090
        • 招聘中
        • Novartis Investigative Site
  • 巴西
    • São Paulo
      • São Paulo、São Paulo、巴西、01246-000
        • 招聘中
        • Novartis Investigative Site
  • 希腊
      • Athens、希腊、115 28
        • 招聘中
        • Novartis Investigative Site
      • Thessaloniki、希腊、540 07
        • 招聘中
        • Novartis Investigative Site
  • 德国
      • Aachen、德国、52074
        • 招聘中
        • Novartis Investigative Site
      • Augsburg、德国、86179
        • 招聘中
        • Novartis Investigative Site
      • Berlin、德国、10249
        • 招聘中
        • Novartis Investigative Site
      • Essen、德国、45147
        • 招聘中
        • Novartis Investigative Site
      • Münster、德国、48149
        • 招聘中
        • Novartis Investigative Site
      • Rostock、德国、18057
        • 招聘中
        • Novartis Investigative Site
    • Bavaria
      • Munich、Bavaria、德国、81377
        • 招聘中
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Cologne、North Rhine-Westphalia、德国、50937
        • 招聘中
        • Novartis Investigative Site
  • 意大利
    • BS
      • Brescia、BS、意大利、25123
        • 撤销
        • Novartis Investigative Site
    • FE
      • Cona、FE、意大利、44124
        • 招聘中
        • Novartis Investigative Site
    • GE
      • Genova、GE、意大利、16132
        • 招聘中
        • Novartis Investigative Site
    • MI
      • Milan、MI、意大利、20141
        • 招聘中
        • Novartis Investigative Site
      • Rozzano、MI、意大利、20089
        • 招聘中
        • Novartis Investigative Site
    • PI
      • Pisa、PI、意大利、56126
        • 招聘中
        • Novartis Investigative Site
    • RM
      • Roma、RM、意大利、00168
        • 招聘中
        • Novartis Investigative Site
    • VR
      • Negrar、VR、意大利、37024
        • 招聘中
        • Novartis Investigative Site
  • 捷克语
      • Olomouc、捷克语、779 00
        • 招聘中
        • Novartis Investigative Site
      • Prague、捷克语、150 06
        • 招聘中
        • Novartis Investigative Site
    • Poruba
      • Ostrava、Poruba、捷克语、708 52
        • 招聘中
        • Novartis Investigative Site
  • 斯洛伐克
      • Bratislava、斯洛伐克、833 10
        • 招聘中
        • Novartis Investigative Site
      • Košice、斯洛伐克、041 91
        • 招聘中
        • Novartis Investigative Site
      • Nitra、斯洛伐克、949 01
        • 招聘中
        • Novartis Investigative Site
      • Trenčín、斯洛伐克、911 01
        • 招聘中
        • Novartis Investigative Site
  • 新加坡
      • Singapore、新加坡、119074
        • 招聘中
        • Novartis Investigative Site
      • Singapore、新加坡、168583
        • 招聘中
        • Novartis Investigative Site
  • 日本
      • Fukuoka、日本、8128582
        • 招聘中
        • Novartis Investigative Site
      • Fukuoka、日本、8110213
        • 招聘中
        • Novartis Investigative Site
      • Fukuoka、日本、8120033
        • 招聘中
        • Novartis Investigative Site
      • Fukushima、日本、9601295
        • 招聘中
        • Novartis Investigative Site
      • Ishikawa、日本、9208641
        • 招聘中
        • Novartis Investigative Site
      • Kyoto、日本、6068507
        • 招聘中
        • Novartis Investigative Site
    • Chiba
      • Kashiwa、Chiba、日本、2778577
        • 招聘中
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo、Hokkaido、日本、0608648
        • 招聘中
        • Novartis Investigative Site
    • Hyōgo
      • Kobe、Hyōgo、日本、6500047
        • 招聘中
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama、Kanagawa、日本、2360004
        • 招聘中
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku、Tokyo、日本、1040045
        • 招聘中
        • Novartis Investigative Site
  • 比利时
      • Aalst、比利时、9300
        • 招聘中
        • Novartis Investigative Site
      • Ghent、比利时、9000
        • 招聘中
        • Novartis Investigative Site
      • Wilrijk、比利时、2610
        • 招聘中
        • Novartis Investigative Site
  • 法国
      • Bordeaux、法国、33076
        • 招聘中
        • Novartis Investigative Site
      • Bron、法国、69677
        • 招聘中
        • Novartis Investigative Site
      • Clermont-Ferrand、法国、63011
        • 招聘中
        • Novartis Investigative Site
      • Rouen、法国、76038
        • 招聘中
        • Novartis Investigative Site
      • Saint-Herblain、法国、44805
        • 招聘中
        • Novartis Investigative Site
    • Hauts De Seine
      • Saint-Cloud、Hauts De Seine、法国、92210
        • 招聘中
        • Novartis Investigative Site
  • 波多黎各
      • San Juan、波多黎各、00921
        • 招聘中
        • VA Caribbean Healthcare System
        • 首席研究员：
          • Bartolo Santiago-Delgado
        • 接触：
  • 澳大利亚
    • New South Wales
      • Darlinghurst、New South Wales、澳大利亚、2010
        • 招聘中
        • Novartis Investigative Site
    • Queensland
      • Herston、Queensland、澳大利亚、4029
        • 招聘中
        • Novartis Investigative Site
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • 招聘中
        • Novartis Investigative Site
    • Victoria
      • Malvern、Victoria、澳大利亚、3144
        • 招聘中
        • Novartis Investigative Site
  • 瑞士
      • Geneva、瑞士、1211
        • 招聘中
        • Novartis Investigative Site
      • Lucerne、瑞士、6006
        • 完全的
        • Novartis Investigative Site
      • Zurich、瑞士、8063
        • 招聘中
        • Novartis Investigative Site
  • 美国
    • Arkansas
      • Fayetteville、Arkansas、美国、72703
        • 招聘中
        • Highlands Oncology Group
        • 首席研究员：
          • Joseph Thaddeus Beck
        • 接触：
    • California
      • Los Angeles、California、美国、90073
        • 招聘中
        • VA Greater LA Healthcare System
        • 首席研究员：
          • Matthew Rettig
        • 接触：
      • Palo Alto、California、美国、94304-1207
        • 招聘中
        • VA Palo Alto Health Care System
        • 首席研究员：
          • Minal Vasanawala
        • 接触：
      • Palo Alto、California、美国、94304
        • 招聘中
        • Stanford University
        • 首席研究员：
          • Hilary Bagshaw
        • 接触：
      • San Francisco、California、美国、94115
        • 招聘中
        • UCSF
        • 首席研究员：
          • Steven Seyedin
        • 接触：
    • Colorado
      • Denver、Colorado、美国、80218
        • 招聘中
        • Rocky Mountain Cancer Centers
        • 首席研究员：
          • Allen Cohn
        • 接触：
    • Florida
      • Jacksonville、Florida、美国、32256
        • 招聘中
        • Cancer Specialists of North Florida
        • 首席研究员：
          • Richard Cassidy
        • 接触：
      • Pensacola、Florida、美国、32503
    • Georgia
      • Atlanta、Georgia、美国、30318
        • 招聘中
        • Piedmont Healthcare
        • 接触：
          • Sharon Joseph
        • 首席研究员：
          • Adam Nowlan
    • Illinois
      • Chicago、Illinois、美国、60637
        • 招聘中
        • University of Chicago
        • 首席研究员：
          • Mohammad Atiq
        • 接触：
      • Elk Grove、Illinois、美国、60007
    • Iowa
      • Des Moines、Iowa、美国、50323
        • 招聘中
        • Unity Point Clinic
        • 接触：
        • 首席研究员：
          • Mark Kellerman
    • Kansas
      • Kansas City、Kansas、美国、66160
        • 招聘中
        • University of Kansas Hospital
        • 首席研究员：
          • Xinglei Shen
        • 接触：
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
        • 招聘中
        • Mary Bird Perkins Cancer Center
        • 首席研究员：
          • Victor Lin
        • 接触：
      • Metairie、Louisiana、美国、70006
    • Maryland
      • Baltimore、Maryland、美国、21231
        • 招聘中
        • Johns Hopkins Kimmel Com Cancer Ctr
        • 首席研究员：
          • Ana Kiess
        • 接触：
      • Baltimore、Maryland、美国、21201
        • 招聘中
        • University of Maryland Medical Ctr
        • 首席研究员：
          • Arif Hussain
        • 接触：
    • Massachusetts
      • Boston、Massachusetts、美国、02115
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Beth Israel Deaconess Med Ctr
        • 首席研究员：
          • David J Einstein
        • 接触：
    • Michigan
      • Grand Rapids、Michigan、美国、49503
        • 撤销
        • BAMF Health
      • Royal Oak、Michigan、美国、48073
        • 招聘中
        • William Beaumont Hospital
        • 首席研究员：
          • Andrew Thompson
        • 接触：
      • Royal Oak、Michigan、美国、48073
        • 撤销
        • Profound Research LLC
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic Rochester
        • 首席研究员：
          • Ryan Phillips
        • 接触：
    • Missouri
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Wash U School of Medicine
        • 首席研究员：
          • Hiram Gay
        • 接触：
      • St Louis、Missouri、美国、63104
      • St Louis、Missouri、美国、63106
        • 撤销
        • VA St Louis Health Care System
    • Nebraska
      • Omaha、Nebraska、美国、68114
        • 招聘中
        • The Urology Center PC DBA UroHealth Partners
        • 首席研究员：
          • Andrew Trainer
        • 接触：
    • New York
      • New York、New York、美国、10065
        • 招聘中
        • Memorial Sloan Kettering Cancer Ctr
        • 首席研究员：
          • Daniel Gorovets
        • 接触：
      • Syracuse、New York、美国、13210
        • 招聘中
        • Associated Med Professionals of NY
        • 首席研究员：
          • Steven Finkelstein
        • 接触：
      • The Bronx、New York、美国、10467-2490
        • 招聘中
        • Montefiore Hospital
        • 首席研究员：
          • Benjamin A Gartrell
        • 接触：
    • North Carolina
      • Greenville、North Carolina、美国、27858
        • 招聘中
        • East Carolina University
        • 首席研究员：
          • Andrew Ju
        • 接触：
    • Ohio
      • Kettering、Ohio、美国、45409
        • 招聘中
        • Dayton Physicians
        • 首席研究员：
          • Trevor Bluemel
        • 接触：
    • Oregon
      • Springfield、Oregon、美国、97477
        • 招聘中
        • Oregon Urology Institute
        • 首席研究员：
          • Bryan Mehlhaff
        • 接触：
    • South Carolina
      • Myrtle Beach、South Carolina、美国、29572
        • 招聘中
        • Carolina Urologic Research Center
        • 首席研究员：
          • Neal D Shore
        • 接触：
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • 招聘中
        • Vanderbilt University Medical Center
        • 首席研究员：
          • Kerry Schaffer
        • 接触：
    • Texas
      • Dallas、Texas、美国、75390-9034
        • 招聘中
        • Univ of Texas Southwest Med Center
        • 首席研究员：
          • Kevin Courtney
        • 接触：
      • El Paso、Texas、美国、79912
    • Virginia
      • Norfolk、Virginia、美国、23502
        • 招聘中
        • Virginia Oncology Associates
        • 首席研究员：
          • Mark Fleming
        • 接触：
      • Wytheville、Virginia、美国、24382
  • 英国
      • Coventry、英国、CV2 2DX
        • 招聘中
        • Novartis Investigative Site
      • London、英国、SW3 6JJ
        • 招聘中
        • Novartis Investigative Site
      • London、英国、NW3 2QG
        • 招聘中
        • Novartis Investigative Site
    • Avon
      • Bristol、Avon、英国、BS2 8ED
        • 招聘中
        • Novartis Investigative Site
    • Surrey
      • Guildford、Surrey、英国、GU2 7XX
        • 招聘中
        • Novartis Investigative Site
  • 荷兰
      • Amsterdam、荷兰、1066 CX
        • 招聘中
        • Novartis Investigative Site
  • 西班牙
      • Barcelona、西班牙、08036
        • 招聘中
        • Novartis Investigative Site
      • Madrid、西班牙、28041
        • 招聘中
        • Novartis Investigative Site
      • Madrid、西班牙、28040
        • 招聘中
        • Novartis Investigative Site
      • Seville、西班牙、41013
        • 招聘中
        • Novartis Investigative Site
      • Valencia、西班牙、46010
        • 招聘中
        • Novartis Investigative Site
    • Andalusia
      • Granada、Andalusia、西班牙、18014
        • 招聘中
        • Novartis Investigative Site
    • Barcelona
      • L'Hospitalet de Llobregat、Barcelona、西班牙、08907
        • 招聘中
        • Novartis Investigative Site
    • Catalonia
      • Barcelona、Catalonia、西班牙、08025
        • 招聘中
        • Novartis Investigative Site
    • Murcia
      • El Palmar、Murcia、西班牙、30120
        • 招聘中
        • Novartis Investigative Site
  • 阿根廷
      • CABA、阿根廷、C1181ACH
        • 招聘中
        • Novartis Investigative Site
      • Caba、阿根廷、C1431FWO
        • 招聘中
        • Novartis Investigative Site
    • Buenos Aires
      • CABA、Buenos Aires、阿根廷、C1426ANZ
        • 招聘中
        • Novartis Investigative Site
  • 马来西亚
      • Kuala Lumpur、马来西亚、59100
        • 招聘中
        • Novartis Investigative Site
    • Selangor
      • Petaling Jaya、Selangor、马来西亚、46050
        • 招聘中
        • Novartis Investigative Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Key Inclusion criteria:

  1. Histologically confirmed prostate cancer prior to randomization

  2. Participants must have biochemically recurrent disease after definitive treatment to prostate by Radical Prostatectomy ((RP), (alone or with post-operative radiation to prostate bed/pelvic nodes)) or External beam Radiation Therapy (EBRT), (prostate alone or prostate with seminal vesicle and/or pelvic nodes) and/or brachytherapy prior to randomization. Biochemical recurrence (BCR) is defined as: nadir PSA + 2 ng/mL post XRT (if participant received-radiation therapy to intact prostate) and PSA > 0.2 ng/mL and rising post RP (with or without post-operation Radiation Therapy (RT))

  3. Participants must have OMPC with 1-5 PSMA -positive metastatic lesions on screening PSMA PET/CT scan (with either gallium (68Ga) gozetotide or piflufolastat (18F)) as visually assessed by BIRC. For definition of PSMA PET positivity, please refer to Section 8.1 and the Imaging Manual. Metastatic lesions may include regional/pelvic lymph nodes (N1), distant lymph nodes (M1a), bone (M1b), lung and others visceral (M1c) except liver and brain classified using American Joint Committee on Cancer (AJCC) 8. When counting the number of oligometastatic lesions, each lesion is counted as distinct metastasis irrespective of its anatomical location (e.g., one pelvic and one extra-pelvic lymph node will be counted as two metastatic lesions)

  4. At least 1 PSMA-positive lesion must be a distant metastasis (M1) per AJCC8 classification at screening. For AJCC M staging, PSMA PET/CT information should be used

  5. Participants must have a negative CI for M1 disease at screening.

    Note:

    • For a participant not to be eligible, CI positive M1 lesions should be unequivocal in CI scans, i.e., potentially not attributable to findings thought to represent something other than tumor (e.g., degenerative, or post-traumatic changes or Paget's disease in bone lesions). For CI assessments, bone lesions must be assessed by bone scan only and soft tissue lesions must be assessed by CT/MRI scans only at screening.
    • Prior knowledge of PSMA PET positivity should not influence the radiologist (reader) in determination of CI positivity. Two different readers will be involved, one reader for PSMA PET/CT scan and one reader for CI: Reader will be blinded to PSMA PET scan results while reading CI scans. Reader should not modify their assessment of CI scans (e.g. changing a lesion previously identified as equivocal in CI to unequivocal) after reading the PSMA PET scan. Similarly, biopsy positivity should not influence the reader in the assessment of CI positivity. More details on the reading paradigm will be provided in the imaging charter
    • MRI for radiation treatment planning may show M1 disease but this will not exclude the participant from the study if the lesion is deemed negative per baseline CT or bone scans
    • Participants with pelvic disease (N1) seen in CI are allowed if the local spread is below common iliac bifurcation (per AJCC 8 definition of local disease)
    • Distant lymph node disease (M1a) that is visible per CI and less than 10mm in the short axis is not exclusionary irrespective of PSMA PET positivity.
    • If a previously surgically removed lesion was unequivocal for M1 by bone scan or CT, the participant is not eligible.

  6. All metastatic lesions detected at screening must be amenable to SBRT

  7. Non-castration testosterone level >100 ng/dL at screening

Key Exclusion criteria:

  1. Participants with de novo OMPC at screening

  2. Unmanageable concurrent bladder outflow obstruction or urinary incontinence at screening. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed

  3. Prior therapy with:

    1. ADT (including bilateral orchiectomy) and ARPIs used for metastatic prostate cancer treatment

      • Participants who received AR-directed therapy, whether ADT or an ARPI or both, as neoadjuvant or adjuvant therapy as a component of their primary therapy, are eligible provided that they discontinued therapy ≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy. ARPI's as a term includes both contemporary androgen synthesis inhibitors (e.g., abiraterone, galeterone, and orteneronel), and receptor inhibitors (enzalutamide, apalutamide and darolutamide).

      • Patients who biochemically relapsed after primary therapy may also have had treatment with AR directed therapy and participants who had SBRT with ADT are also eligible provided that the ARPI +/- ADT or ADT alone was terminated

        ≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy.

      • Participants who received first generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) for biochemical recurrence or adjuvant/neoadjuvant therapy are eligible provided that they discontinued therapy ≥3 months prior to randomization.

      • Participants who have discontinued ADT due to disease progression are not eligible (i.e., Castration-Resistant Prostate Cancer (CRPC) participants)

    2. Other hormonal therapy. e.g.,

      •Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) if used in the context of prostate cancer treatment. Same medications are allowed if used for other indications: e.g., Benign Prostatic Hyperplasia (BPH), if stopped ≥3 months before randomization.

    3. Radiopharmaceutical agents (e.g., Strontium-89, PSMA-targeted radioligand therapy)

    4. Immunotherapy (e.g., sipuleucel-T)

    5. Chemotherapy, except if administered in the adjuvant/neoadjuvant setting completed > 12 months before randomization

    6. Any other investigational or systemic agents for metastatic disease

  4. Radiation therapy external beam radiation therapy (EBRT) and brachytherapy within 28 days before randomization

  5. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, hormonal therapy (see ADT initiation guidance in Section 6.8.2), Poly Adenosine Diphosphate-Ribose Polymerase (PARP) inhibitor, biological therapy or investigational therapy

  6. Diagnosed at screening with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease/treatment free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer.

  7. History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as:

    • Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree Atrioventricular (AV) block without a pacemaker
    • History of familial long QT syndrome or known family history of Torsades de Pointe

  8. Participants in immediate need of ADT or other systemic therapy as assessed by the investigator. In addition, investigators should only enroll participants who are committed to delay castration in accordance with the scope of the study and are willing to wait to start systemic therapy until distant progression (MFS event) as assessed by CI (consisting with existing treatment guidelines) and confirmed by BIRC is reached. This must be discussed with the participants before ICF is signed.

Other protocol defined Inclusion/Exclusion may apply.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Investigational Arm: lutetium (177Lu) vipivotide tetraxetan (AAA617)

All participants will be treated with Stereotactic Body Radiation Therapy (SBRT) to all metastatic lesions followed by a dose of 7.4 GBq (200 mCi) +/- 10% of AAA617 which will be administered once every 6 weeks (1 cycle) for a planned 4 cycles.
药品：AAA617

Radiopharmaceutical solution for infusion/injection

其他名称：
  • (177Lu) vipivotide 四西坦
药品：piflufolastat (18F)

Provided as ready-to-use radiopharmaceutical

药品：gallium (68Ga) gozetotide (25μg)

Provided as PSMA-11 Kit for radiopharmaceutical preparation of gallium (68Ga) gozetotide
无干预：Control arm: observation (watchful waiting)

All participants will be treated with Stereotactic Body Radiation Therapy (SBRT) to all metastatic lesions followed by observation only.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS)
大体时间：From date of randomization until first evidence of radiographically detectable bone or soft tissue distant metastasis or death due to any cause, whichever occurs first, assessed up to approximately 30 months

Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS) is defined as the time from randomization to first evidence of radiographically detectable bone or soft tissue distant metastasis by conventional imaging (i.e., Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) and bone scans) as assessed by BIRC using RECIST 1.1 or death due to any cause, whichever occurs first.

Participants who are alive without distant metastasis at the analysis data cut-off or are lost to follow-up at the time of analysis will be censored for MFS at the time of their last adequate radiographic assessment. Clinical deterioration without objective radiographic evidence will not be considered as documented distant metastasis.
From date of randomization until first evidence of radiographically detectable bone or soft tissue distant metastasis or death due to any cause, whichever occurs first, assessed up to approximately 30 months

次要结果测量

结果测量
措施说明
大体时间
Key secondary endpoint: Time to Hormonal Therapy (TTHT)
大体时间：From date of randomization until date of Androgen Deprivation Therapy (ADT), assessed up to approximately 74 months

Time to Hormonal Therapy (TTHT) is defined as the time from randomization to the time to Androgen Deprivation Therapy (ADT). The type of hormonal therapy will be at the discretion of the Investigator.
From date of randomization until date of Androgen Deprivation Therapy (ADT), assessed up to approximately 74 months
Investigator assessed Metastasis Free Survival (MFS)
大体时间：From date of randomization until first evidence of radiographically detectable bone or soft tissue distant metastasis or death from any cause, whichever occurs first, assessed up to approximately 74 months

Investigator assessed Metastasis Free Survival (MFS) is defined as the time from randomization to the first evidence of radiographically detectable bone or soft tissue distant metastasis by conventional imaging (i.e., CT/MRI and bone scans) as assessed by Investigator using RECIST 1.1 or death from any cause, whichever occurs first.
From date of randomization until first evidence of radiographically detectable bone or soft tissue distant metastasis or death from any cause, whichever occurs first, assessed up to approximately 74 months
Time to prostate specific antigen (PSA) progression (TTPSAP)
大体时间：From date of randomization until date of first PSA progression, assessed up to approximately 74 months

Time to prostate specific antigen (PSA) progression (TTPSAP) is defined as time from randomization to first PSA progression 1. First PSA progression 1 is defined as a rising PSA confirmed on repeated measurement at least 3 weeks later, and at least greater than 25% and >= 2 ng/mL above nadir or baseline, whichever is lower. In the absence of PSA progression, TTPSAP will be censored at the last PSA measurement.
From date of randomization until date of first PSA progression, assessed up to approximately 74 months
Radiographic Progression Free Survival (rPFS)
大体时间：From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 74 months

Radiographic progression free survival (rPFS) is defined as the time from randomization to first documentation of confirmed radiographic progressive disease or death due to any cause (whichever occurs first) by conventional imaging (i.e., CT/MRI and bone scans) using RECIST 1.1. The rPFS will be analyzed based on BIRC and Investigator assessments respectively.
From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 74 months
Time to next therapy (local or systemic)
大体时间：From date of randomization until initiation of the next line of therapy (local or systemic), assessed up to approximately 74 months

Time to next therapy (local or systemic) is defined as the time from randomization to initiation of the next line of therapy (local or systemic). Next-line therapy is defined as the first new (local or systemic) anti-neoplastic therapy initiated after discontinuation of study treatment regardless of end of treatment (EOT) reason.
From date of randomization until initiation of the next line of therapy (local or systemic), assessed up to approximately 74 months
24-month prostate-specific antigen (PSA) progression free survival (PFS)
大体时间：From date of randomization until date of first documented PSA progression 2 or death from any cause, whichever occurs first, assessed up to approximately 74 months

24-month PSA PFS is defined as PSA PFS at 24 months. PSA PFS is defined as the time from date of randomization to the date of first documented PSA progression 2 or death from any cause, whichever occurs first. PSA progression 2 is defined as a PSA concentration above the nadir (or baseline if lower) of >= 0.5 ng/mL, confirmed by repeated measurement at least 3 weeks later. PSA PFS will be censored if no PSA PFS event is observed before the first to occur analysis cut-off date. The censoring date will be the date of the last adequate tumor assessment prior to cut-off.
From date of randomization until date of first documented PSA progression 2 or death from any cause, whichever occurs first, assessed up to approximately 74 months
Time to symptomatic progression
大体时间：From date of randomization until date of first documented symptomatic progression, assessed up to approximately 74 months

Time to symptomatic progression is defined as time from randomization to the date of first documented event for any of the following, whichever occurs first: development of symptomatic skeletal event, escalation in cancer-related pain or worsening of disease-related symptoms leading to the initiation of a new systemic anticancer therapy, development of clinically significant symptoms due to local or regional tumor progression leading to surgery or radiation therapy.
From date of randomization until date of first documented symptomatic progression, assessed up to approximately 74 months
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
大体时间：From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months

FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.
From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT) Questionnaire
大体时间：From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months

The FACT-RNT (Functional Assessment of Cancer Therapy - Radionuclide Therapy) is a Patient Reported Outcomes (PRO) new measure developed using FACIT specific questions (items), selected from FACIT item bank, to assess treatment-related symptoms of special interest associated with radioligand therapies.

The FACT-RNT contains items assessing dry mouth, dry eyes, vomiting, diarrhea, constipation, loss of appetite, fatigue, impact of fatigue, bone pain, and isolation due to illness or treatment. FACT-RNT score range 0 to 60, with higher score indicating better quality of life.
From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
Brief Pain Inventory - Short Form (BPI-SF) Questionnaire
大体时间：From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months

The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.
From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
European Quality of Life (EuroQol) - 5 Domain 5 Level scale (EQ-5D- 5L)
大体时间：From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months

EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
Time to First Symptomatic Skeletal Event (TTSE)
大体时间：From date of randomization till end of treatment (EOT) or death, whichever happens first, assessed up to approximately 74 months

Time to first symptomatic skeletal event (TTSSE) is defined as date of randomization to the date of first new SSE or death from any cause, whichever occurs first. Symptomatic skeletal events (SSE) will be defined by the occurrence of any of the following (whichever occurs earlier): symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain.
From date of randomization till end of treatment (EOT) or death, whichever happens first, assessed up to approximately 74 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
大体时间：From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months

The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
Dose modifications and intensity for AAA617
大体时间：From date of randomization until end of treatment (EOT), assessed up to approximately 30 months

Dose modifications (dose interruptions and reductions) and dose intensity for AAA617 will be assessed and summarized using descriptive statistics.
From date of randomization until end of treatment (EOT), assessed up to approximately 30 months
Overall survival (OS)
大体时间：From date of randomization until date of death from any cause, assessed up to approximately 74 months

Overall Survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. OS time for participants who are alive at the end of the study or are lost to follow-up will be censored at the date of last contact.
From date of randomization until date of death from any cause, assessed up to approximately 74 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

调查人员

  • 研究主任：Novartis Pharmaceuticals、Novartis Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年3月12日

初级完成 (估计的)

2028年4月25日

研究完成 (估计的)

2031年10月3日

研究注册日期

首次提交

2023年7月3日

首先提交符合 QC 标准的

2023年7月3日

首次发布 (实际的)

2023年7月11日

研究记录更新

最后更新发布 (实际的)

2026年10月21日

上次提交的符合 QC 标准的更新

2026年10月20日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CAAA617D12302
  • 2022-502956-29-00 (其他标识符：EU CT number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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