Phase
Condition
Prostate Disorders
Prostate Cancer
Prostate Cancer, Early, Recurrent
Treatment
ARPI
AAA817
Standard of Care
Clinical Study ID
Ages 18-100 Male
Study Summary
Eligibility Criteria
Inclusion
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 ofadenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine)are not eligible.
Participants who have received taxane-based chemotherapy in mHSPC setting areeligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 asthe next line of therapy in the opinion of the Investigator. Note: Participants whohave 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 isapproved as per protocol.
Participant must have been diagnosed with mCRPC with documented progressive diseasewhile 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 somatichomologous recombination repair (HRR) gene-mutated metastaticcastration-resistant prostate cancer, as per local testing, may be enrolled ifthey had prior exposure to PARPi.
Exclusion
Key Exclusion Criteria:
Previous anti-cancer treatment with any approved or investigationalradiopharmaceuticals (for example, [177Lu]Lu-PSMA, [177Lu]-DOTA, or Radium- 223.)
Previous treatment with any external beam radiotherapy including hemi-body radiationwithin 6 weeks of randomization (within 2 weeks for radiotherapy of localizedmetastases).
Any prior PARP inhibitor or other systemic anticancer therapy administered formetastatic castration-resistant prostate cancer (mCRPC). Any other approved orinvestigational systemic therapy (including chemotherapy, immunotherapy,biologics, or monoclonal antibodies) is prohibited within 28 days or 5half-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.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Novartis Investigative Site
Darlinghurst 2169378, New South Wales 2155400 2010
AustraliaActive - Recruiting
Novartis Investigative Site
Adelaide, South Australia 5000
AustraliaSite Not Available
Novartis Investigative Site
Adelaide 2078025, South Australia 2061327 5000
AustraliaActive - Recruiting
Novartis Investigative Site
São Paulo 3448439, São Paulo 3448433 05652-000
BrazilActive - Recruiting
Novartis Investigative Site
Guangzhou 1809858, Guangdong 1809935 510632
ChinaActive - Recruiting
Novartis Investigative Site
Wuhan 1791247, Hubei 1806949 430022
ChinaActive - Recruiting
Novartis Investigative Site
Nanjing 1799962, Jiangsu 1806260 210029
ChinaActive - Recruiting
Novartis Investigative Site
Shenyang 2034937, Liaoning 2036115 110011
ChinaActive - Recruiting
Novartis Investigative Site
Chengdu, Sichuan 610041
ChinaSite Not Available
Novartis Investigative Site
Chengdu 1815286, Sichuan 1794299 610041
ChinaActive - Recruiting
Novartis Investigative Site
Hangzhou 1808926, Zhejiang 1784764 310022
ChinaActive - Recruiting
Novartis Investigative Site
Beijing 1816670, 100036
ChinaActive - Recruiting
Novartis Investigative Site
Guangzhou, 510060
ChinaSite Not Available
Novartis Investigative Site
Shanghai 1796236, 200025
ChinaActive - Recruiting
Novartis Investigative Site
Tianjin, 300308
ChinaSite Not Available
Novartis Investigative Site
Hong Kong 1819729, 999077
Hong KongActive - Recruiting
Novartis Investigative Site
Pokfulam, 999077
Hong KongSite Not Available
Novartis Investigative Site
Gurgaon 1270642, Haryana 1270260 122 002
IndiaActive - Recruiting
Novartis Investigative Site
Mumbai 1275339, Maharashtra 1264418 400 012
IndiaActive - Recruiting
Novartis Investigative Site
Sapporo city, Hokkaido 060 8648
JapanSite Not Available
Novartis Investigative Site
Sapporo 2128295, Hokkaido 2130037 0608648
JapanActive - Recruiting
Novartis Investigative Site
Kobe 1859171, Hyōgo 1862047 6500047
JapanActive - Recruiting
Novartis Investigative Site
Yokohama 1848354, Kanagawa-ku 236-0004
JapanActive - Recruiting
Novartis Investigative Site
Chuo Ku, Tokyo 1850144 1040045
JapanActive - Recruiting
Novartis Investigative Site
Chiba 2113015, 260-8717
JapanActive - Recruiting
Novartis Investigative Site
Fukuoka 1863967, 8128582
JapanActive - Recruiting
Novartis Investigative Site
Hiroshima 1862415, 7348551
JapanActive - Recruiting
Novartis Investigative Site
Kyoto 1857910, 6068507
JapanActive - Recruiting
Novartis Investigative Site
Singapore, 119074
SingaporeSite Not Available
Novartis Investigative Site
Singapore 1880252, 168583
SingaporeActive - Recruiting
Novartis Investigative Site
Seoul 1835848, 06351
South KoreaActive - Recruiting
Novartis Investigative Site
Kaohsiung City 1673820, 83301
TaiwanActive - Recruiting
Novartis Investigative Site
Taoyuan District 1667905, 33305
TaiwanActive - Recruiting
Novartis Investigative Site
Sutton 2636503, Surrey SM2 5PT
United KingdomActive - Recruiting
Sansum Clinic
Santa Barbara 5392952, California 5332921 93105
United StatesActive - Recruiting
Rocky Mountain Cancer Centers
Denver 5419384, Colorado 5417618 80218
United StatesActive - Recruiting
Miami Cancer Institute at Bapt
Miami 4164138, Florida 4155751 33173
United StatesActive - Recruiting
AdventHealth
Orlando 4167147, Florida 4155751 32804
United StatesActive - Recruiting
Univ Of Iowa Hospitals And Clinics
Iowa City 4862034, Iowa 4862182 52242
United StatesActive - Recruiting
University of Kansas Hospital
Kansas City 4273837, Kansas 4273857 66160
United StatesActive - Recruiting
Wash U School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Bassett Medical Center
Cooperstown 5113664, New York 5128638 13326
United StatesActive - Recruiting
Weill Cornell Medicine NY-Presb
New York 5128581, New York 5128638 10021
United StatesActive - Recruiting
University of Rochester Medical Ctr
Rochester 5134086, New York 5128638 14642
United StatesActive - Recruiting
Associated Med Professionals of NY
Syracuse 5140405, New York 5128638 13210
United StatesActive - Recruiting
Carolina Urologic Research Center
Myrtle Beach 4588718, South Carolina 4597040 29572
United StatesActive - Recruiting
Urology San Antonio
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting
Swedish Medical Center
Seattle 5809844, Washington 5815135 98122-4379
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesActive - Recruiting

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