RecruitingPhase IIIMale onlyEN originalProstate cancerMetastatic / advanced

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

⚠️

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 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).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzona histologicznie diagnoza raka prostaty
  • Nawrót choroby po radykalnym leczeniu (operacja prostaty lub radioterapia)
  • 1-5 przerzutów widocznych w badaniu obrazowym PSMA PET/CT
  • Co najmniej jeden przerzut poza lokal pierwotnego guza
  • Dodatnia próba PSMA w obrazach diagnostycznych

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
100 Years
Last updated (source)
August 3, 2026
Sex
Male only

Therapies / drugs in trial

Locations (144)

Highlands Oncology Group

Fayetteville, United States

VA Greater LA Healthcare System

Los Angeles, United States

VA Palo Alto Health Care System

Palo Alto, United States

Stanford University

Palo Alto, United States

UCSF

San Francisco, United States

Rocky Mountain Cancer Centers

Denver, United States

Cancer Specialists of North Florida

Jacksonville, United States

Woodlands Medical Specialists

Pensacola, United States

Piedmont Healthcare

Atlanta, United States

University of Chicago

Chicago, United States

The Cancer Institute of Alexian Brothers

Elk Grove, United States

Unity Point Clinic

Des Moines, United States

University of Kansas Hospital

Kansas City, United States

Mary Bird Perkins Cancer Center

Baton Rouge, United States

East Jefferson Hospital

Metairie, United States

University of Maryland Medical Ctr

Baltimore, United States

Johns Hopkins Kimmel Com Cancer Ctr

Baltimore, United States

Dana Farber Cancer Institute

Boston, United States

Beth Israel Deaconess Med Ctr

Boston, United States

BAMF Health

Grand Rapids, United States

Profound Research LLC

Royal Oak, United States

William Beaumont Hospital

Royal Oak, United States

Mayo Clinic Rochester

Rochester, United States

St Louis University

St Louis, United States

VA St Louis Health Care System

St Louis, United States

Wash U School of Medicine

St Louis, United States

The Urology Center PC DBA UroHealth Partners

Omaha, United States

Memorial Sloan Kettering Cancer Ctr

New York, United States

Associated Med Professionals of NY

Syracuse, United States

Montefiore Hospital

The Bronx, United States

East Carolina University

Greenville, United States

Dayton Physicians

Kettering, United States

Oregon Urology Institute

Springfield, United States

Carolina Urologic Research Center

Myrtle Beach, United States

Vanderbilt University Medical Center

Nashville, United States

Univ of Texas Southwest Med Center

Dallas, United States

Rio Grande Urology

El Paso, United States

Virginia Oncology Associates

Norfolk, United States

Blue Ridge Cancer Center

Wytheville, United States

Novartis Investigative Site

CABA, Argentina

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CABA, Argentina

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Caba, Argentina

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Darlinghurst, Australia

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Herston, Australia

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Adelaide, Australia

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Malvern, Australia

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Linz, Austria

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Vienna, Austria

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Aalst, Belgium

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Ghent, Belgium

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Wilrijk, Belgium

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São Paulo, Brazil

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Calgary, Canada

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Halifax, Canada

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London, Canada

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Ottawa, Canada

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Toronto, Canada

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Montreal, Canada

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Montreal, Canada

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Québec, Canada

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Beijing, China

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Guangzhou, China

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Shanghai, China

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Bogota, Colombia

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Bogotá, Colombia

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Ostrava, Czechia

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Olomouc, Czechia

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Prague, Czechia

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Saint-Cloud, France

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Bordeaux, France

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Bron, France

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Clermont-Ferrand, France

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Rouen, France

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Saint-Herblain, France

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Munich, Germany

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Cologne, Germany

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Aachen, Germany

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Augsburg, Germany

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Berlin, Germany

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Essen, Germany

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Münster, Germany

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Rostock, Germany

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Athens, Greece

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Thessaloniki, Greece

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Debrecen, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Beersheba, Israel

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Haifa, Israel

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Jerusalem, Israel

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Petah Tikva, Israel

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Tel Aviv, Israel

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Brescia, Italy

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Cona, Italy

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Genova, Italy

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Milan, Italy

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Rozzano, Italy

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Pisa, Italy

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Roma, Italy

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Negrar, Italy

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Kashiwa, Japan

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Sapporo, Japan

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Kobe, Japan

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Yokohama, Japan

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Chuo Ku, Japan

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Fukuoka, Japan

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Fukuoka, Japan

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Fukuoka, Japan

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Fukushima, Japan

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Ishikawa, Japan

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Kyoto, Japan

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Petaling Jaya, Malaysia

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Kuala Lumpur, Malaysia

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Mexico City, Mexico

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Huxquilucan, Mexico

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Amsterdam, Netherlands

VA Caribbean Healthcare System

San Juan, Puerto Rico

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Singapore, Singapore

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Singapore, Singapore

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Bratislava, Slovakia

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Košice, Slovakia

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Nitra, Slovakia

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Trenčín, Slovakia

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Granada, Spain

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L'Hospitalet de Llobregat, Spain

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Barcelona, Spain

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El Palmar, Spain

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Seville, Spain

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Valencia, Spain

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Geneva, Switzerland

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Lucerne, Switzerland

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Zurich, Switzerland

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Bristol, United Kingdom

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Guildford, United Kingdom

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Coventry, United Kingdom

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London, United Kingdom

Novartis Investigative Site

London, United Kingdom

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/4/2026.

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