RecruitingPhase 3NCT05939414

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

An International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)

Sponsor

Novartis Pharmaceuticals

Enrollment

450 participants

Start Date

Mar 12, 2024

Study Type

INTERVENTIONAL

Conditions

Oligometastatic Prostate Cancer (OMPC)

Summary

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).

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a targeted radiation therapy called lutetium-177 PSMA (which delivers radiation directly to prostate cancer cells using a radioactive molecule) versus watchful waiting in men with prostate cancer that has come back after surgery or radiation but has not yet spread widely. **You may be eligible if...** - You have a confirmed diagnosis of prostate cancer - Your PSA (prostate-specific antigen blood test) level is rising after definitive treatment (surgery or external radiation) - A PSMA-PET scan shows your cancer is PSMA-positive (meaning the tracer can target it) - You have limited sites of disease (oligometastatic or biochemically recurrent) **You may NOT be eligible if...** - Your cancer has spread widely (multiple distant metastases) - You have already received certain prostate cancer treatments like hormonal therapy or chemotherapy - Your kidneys or other organs are not functioning well enough - You have other serious illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAAA617

Radiopharmaceutical solution for infusion/injection

DRUGpiflufolastat (18F)

Provided as ready-to-use radiopharmaceutical

DRUGgallium (68Ga) gozetotide (25μg)

Provided as PSMA-11 Kit for radiopharmaceutical preparation of gallium (68Ga) gozetotide

Locations(144)

Highlands Oncology Group

Fayetteville, Arkansas, United States

VA Greater LA Healthcare System

Los Angeles, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Stanford University

Palo Alto, California, United States

UCSF

San Francisco, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Woodlands Medical Specialists

Pensacola, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

The Cancer Institute of Alexian Brothers

Elk Grove, Illinois, United States

Unity Point Clinic

Des Moines, Iowa, United States

University of Kansas Hospital

Kansas City, Kansas, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

East Jefferson Hospital

Metairie, Louisiana, United States

University of Maryland Medical Ctr

Baltimore, Maryland, United States

Johns Hopkins Kimmel Com Cancer Ctr

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States

BAMF Health

Grand Rapids, Michigan, United States

Profound Research LLC

Royal Oak, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

St Louis University

St Louis, Missouri, United States

VA St Louis Health Care System

St Louis, Missouri, United States

Wash U School of Medicine

St Louis, Missouri, United States

The Urology Center PC DBA UroHealth Partners

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Ctr

New York, New York, United States

Associated Med Professionals of NY

Syracuse, New York, United States

Montefiore Hospital

The Bronx, New York, United States

East Carolina University

Greenville, North Carolina, United States

Dayton Physicians

Kettering, Ohio, United States

Oregon Urology Institute

Springfield, Oregon, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Univ of Texas Southwest Med Center

Dallas, Texas, United States

Rio Grande Urology

El Paso, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Blue Ridge Cancer Center

Wytheville, Virginia, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Darlinghurst, New South Wales, Australia

Novartis Investigative Site

Herston, Queensland, Australia

Novartis Investigative Site

Adelaide, South Australia, Australia

Novartis Investigative Site

Malvern, Victoria, Australia

Novartis Investigative Site

Linz, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Aalst, Belgium

Novartis Investigative Site

Ghent, Belgium

Novartis Investigative Site

Wilrijk, Belgium

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Calgary, Alberta, Canada

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Novartis Investigative Site

London, Ontario, Canada

Novartis Investigative Site

Ottawa, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Guangzhou, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Novartis Investigative Site

Bogotá, Colombia

Novartis Investigative Site

Ostrava, Poruba, Czechia

Novartis Investigative Site

Olomouc, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Saint-Cloud, Hauts De Seine, France

Novartis Investigative Site

Bordeaux, France

Novartis Investigative Site

Bron, France

Novartis Investigative Site

Clermont-Ferrand, France

Novartis Investigative Site

Rouen, France

Novartis Investigative Site

Saint-Herblain, France

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Aachen, Germany

Novartis Investigative Site

Augsburg, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Münster, Germany

Novartis Investigative Site

Rostock, Germany

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Thessaloniki, Greece

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Beersheba, Israel

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Jerusalem, Israel

Novartis Investigative Site

Petah Tikva, Israel

Novartis Investigative Site

Tel Aviv, Israel

Novartis Investigative Site

Brescia, BS, Italy

Novartis Investigative Site

Cona, FE, Italy

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Rozzano, MI, Italy

Novartis Investigative Site

Pisa, PI, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Negrar, VR, Italy

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Chuo Ku, Tokyo, 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

Petaling Jaya, Selangor, Malaysia

Novartis Investigative Site

Kuala Lumpur, Malaysia

Novartis Investigative Site

Mexico City, Mexico City, Mexico

Novartis Investigative Site

Huxquilucan, Mexico

Novartis Investigative Site

Amsterdam, Netherlands

VA Caribbean Healthcare System

San Juan, Puerto Rico

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Bratislava, Slovakia

Novartis Investigative Site

Košice, Slovakia

Novartis Investigative Site

Nitra, Slovakia

Novartis Investigative Site

Trenčín, Slovakia

Novartis Investigative Site

Granada, Andalusia, Spain

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

El Palmar, Murcia, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Seville, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Geneva, Switzerland

Novartis Investigative Site

Lucerne, Switzerland

Novartis Investigative Site

Zurich, Switzerland

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taoyuan, Taiwan

Novartis Investigative Site

Bristol, Avon, United Kingdom

Novartis Investigative Site

Guildford, Surrey, United Kingdom

Novartis Investigative Site

Coventry, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05939414

Related Trials

HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases (HIMARS)

NCT069782961 location

Trial of pTVG-HP+Nivo+Targeted Ablation of Resistant Lesions in Non-Castrate RecurrentOMPC

NCT070901481 location