RecruitingPhase II/IIIMale onlyEN originalProstate cancerMetastatic / advanced

Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

⚠️

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

This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek 18 lat lub więcej
  • •Nowotwór prostaty potwierdzony badaniem histologicznym lub cytologicznym
  • •Rak prostaty ze zmianami wykrywalnym specjalnym testem obrazowym (PSMA PET/CT)
  • •Niski poziom testosteronu we krwi (poniżej 50 ng/dL)
  • •Wcześniejsze leczenie co najmniej dwoma rodzajami chemioterapii lub hormonoterapii
  • •Postęp choroby po leczeniu radioaktywnym Lu-177 PSMA
  • •Co najmniej jedna widoczna zmiana przerzutowa w badaniach obrazowych z ostatnich 28 dni
  • •Prawidłowa funkcja nerek (zgodnie z wymogami badania)

✗ Disqualifies

  • •Udzielanie się w innym badaniu klinicznym w ciągu ostatnich 28 dni
  • •Wcześniejsze leczenie radioaktywnym aktynem-225
  • •Przerzuty do mózgu powodujące objawy lub wymagające sterydów
  • •Ostre lub przewlekłe problemy z nerkami
  • •Poważne suchość ust
  • •Nieregulowane nadciśnienie lub zaburzenia serca w ostatnich 6 miesiącach
  • •Inne nowotwory lub historia nowotworów w ostatnich 2 latach (poza drobnoustrojami skóry)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
100 Years
Last updated (source)
September 22, 2026
Sex
Male only

Therapies / drugs in trial

Locations (93)

Honor Health Research Institute

Scottsdale, United States

VA Greater LA Healthcare System

Los Angeles, United States

VA Palo Alto Health Care System

Palo Alto, United States

Stanford University Medical Center

Palo Alto, United States

Sansum Clinic

Santa Barbara, United States

Saint Johns Cancer Institute

Santa Monica, United States

Rocky Mountain Cancer Centers

Denver, United States

Hartford Hospital

Hartford, United States

Baptist Health South

Miami, United States

AdventHealth

Orlando, United States

University Cancer and Blood Center LLC

Athens, United States

Emory University

Atlanta, United States

University of Chicago

Chicago, United States

Indiana University

Indianapolis, United States

University of Kansas Hospital

Kansas City, United States

East Jefferson Hospital

Metairie, United States

Dana Farber Cancer Institute

Boston, United States

Beth Israel Deaconess Medical Center

Boston, United States

WA Uni School Of Med

St Louis, United States

Nebraska Cancer Specialists

Omaha, United States

New Jersey Urology LLC

Voorhees Township, United States

Mount Sinai Hosp Med School

New York, United States

Associated Med Professionals of NY

Syracuse, United States

Montefiore Medical Center

The Bronx, United States

Central Ohio Urology Group

Gahanna, United States

Oregon Urology Institute

Springfield, United States

Fox Chase Cancer Center

Philadelphia, United States

Carolina Urologic Research Center

Myrtle Beach, United States

Texas Oncology

Dallas, United States

Urology San Antonio

San Antonio, United States

Utah Intermountain Medical Center

Murray, United States

Virginia Cancer Specialists

Fairfax, United States

Onco Hemato Asso of SW Virginia

Roanoke, United States

Fred Hutchinson Cancer Research Center

Seattle, United States

Medical College Of Wisconsin

Milwaukee, United States

Novartis Investigative Site

Darlinghurst, Australia

Novartis Investigative Site

Herston, Australia

Novartis Investigative Site

Melbourne, Australia

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

Fuzhou, 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

Xian, China

Novartis Investigative Site

Xian, China

Novartis Investigative Site

Chengdu, 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

Tianjin, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Hong Kong, Hong Kong

Novartis Investigative Site

Beersheba, Israel

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Jerusalem, Israel

Novartis Investigative Site

Petah Tikva, Israel

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Tel Aviv, Israel

Novartis Investigative Site

Kashiwa, Japan

Novartis Investigative Site

Sapporo, Japan

Novartis Investigative Site

Kobe, Japan

Novartis Investigative Site

Yokohama, 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

Ishikawa, Japan

Novartis Investigative Site

Kyoto, Japan

Novartis Investigative Site

Putrajaya, Malaysia

Novartis Investigative Site

Petaling Jaya, Malaysia

Novartis Investigative Site

Petaling Jaya, Malaysia

Novartis Investigative Site

Mexico City, Mexico

Novartis Investigative Site

Huxquilucan, Mexico

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

Basel, Switzerland

Novartis Investigative Site

Bellinzona, Switzerland

Novartis Investigative Site

Bern, Switzerland

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taoyuan, Taiwan

Trial contact

Novartis Pharmaceuticals

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/23/2026.

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