RecruitingPhase IIIMale onlyEN originalProstate cancerMetastatic / advanced

Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat
  • Potwierdzony histologicznie lub cytologicznie rak gruczołowy prostaty
  • Nowotwór dodatni w badaniu PET na PSMA
  • Wcześniejsze leczenie inhibitorem ARPI jako ostatnie leczenie przed włączeniem do badania
  • Brak wcześniejszego leczenia chemioterapią dla zaawansowanego raka prostaty opornego na kastrację
  • Ogólny stan zdrowia pozwalający na udział w badaniu (wynik ECOG 0-2)
  • Świadoma zgoda na udział w badaniu

✗ Disqualifies

  • Wcześniejsze leczenie radiofarmakami (np. Lu-177 PSMA, Ra-223)
  • Wcześniejsze leczenie inhibitorem PARP lub inną chemioterapią dla zaawansowanego raka prostaty opornego na kastrację
  • Napromienianie zewnętrzne w ciągu ostatnich 6 tygodni przed włączeniem do badania
  • Rak prostaty z komponentą neuroendokrynną (mieszana histologia)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
100 Years
Last updated (source)
July 24, 2026
Sex
Male only

Therapies / drugs in trial

Locations (88)

Urology Centers Of Alabama Pc

Homewood, United States

Stanford University Medical Center

Palo Alto, United States

Sansum Clinic

Santa Barbara, United States

Rocky Mountain Cancer Centers

Denver, United States

Florida Cancer Specialists

Fort Myers, United States

Baptist Health South

Miami, United States

AdventHealth

Orlando, United States

University Cancer and Blood Center LLC

Athens, United States

Northwestern University

Chicago, United States

Univ Of Iowa Hospitals And Clinics

Iowa City, United States

University of Kansas Hospital

Kansas City, United States

East Jefferson Hospital

Metairie, United States

Beth Israel Deaconess Med Center

Boston, United States

Dana Farber Cancer Institute

Boston, United States

Karmanos Cancer Institute

Detroit, United States

Wash U School of Medicine

St Louis, United States

Nebraska Cancer Specialists

Omaha, United States

Astera Cancer Center

East Brunswick, United States

New Jersey Urology LLC

Voorhees Township, United States

Bassett Medical Center

Cooperstown, United States

Weill Cornell Medicine NY-Presb

New York, United States

University of Rochester Medical Ctr

Rochester, United States

Associated Med Professionals of NY

Syracuse, United States

Montefiore Medical Center

The Bronx, United States

Central Ohio Urology Group

Gahanna, United States

MUSC Hollings Cancer Center

Charleston, United States

Carolina Urologic Research Center

Myrtle Beach, United States

Tennessee Oncology PLLC

Chattanooga, United States

Urology San Antonio

San Antonio, United States

Woodlands Cancer Institute American Oncology Partners

The Woodlands, United States

Swedish Medical Center

Seattle, United States

Northwest Medical Specialties

Tacoma, United States

Medical College of Wisconsin

Milwaukee, United States

Novartis Investigative Site

Darlinghurst, Australia

Novartis Investigative Site

Adelaide, Australia

Novartis Investigative Site

Malvern, Australia

Novartis Investigative Site

Murdoch, Australia

Novartis Investigative Site

Adelaide, Australia

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

Fuzhou, China

Novartis Investigative Site

Guangzhou, China

Novartis Investigative Site

Guangzhou, China

Novartis Investigative Site

Wuhan, China

Novartis Investigative Site

Wuhan, China

Novartis Investigative Site

Nanjing, China

Novartis Investigative Site

Nanjing, China

Novartis Investigative Site

Shenyang, China

Novartis Investigative Site

Chengdu, China

Novartis Investigative Site

Hangzhou, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Guangzhou, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Hong Kong, Hong Kong

Novartis Investigative Site

Gurgaon, India

Novartis Investigative Site

Bengaluru, India

Novartis Investigative Site

Mumbai, India

Novartis Investigative Site

Nagoya, Japan

Novartis Investigative Site

Sapporo, Japan

Novartis Investigative Site

Kobe, Japan

Novartis Investigative Site

Kobe, Japan

Novartis Investigative Site

Yokohama, Japan

Novartis Investigative Site

Chuo Ku, Japan

Novartis Investigative Site

Chiba, Japan

Novartis Investigative Site

Fukuoka, Japan

Novartis Investigative Site

Fukuoka, Japan

Novartis Investigative Site

Fukuoka, Japan

Novartis Investigative Site

Fukushima, Japan

Novartis Investigative Site

Hiroshima, Japan

Novartis Investigative Site

Kyoto, Japan

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Kaohsiung City, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taoyuan, Taiwan

Novartis Investigative Site

Sutton, United Kingdom

Trial contact

Novartis Pharmaceuticals

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/26/2026.

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