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NCT04720157

PHASE3

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care (SOC), versus Standard of Care alone, in adult male patients with Metastatic hormone sensitive prostate cancer (mHSPC). In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study. As of 31-Jan-2024, 1144 participants were enrolled in 20 countries.

Official title: An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Key Details

Gender

MALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

1145

Start Date

2021-06-09

Completion Date

2027-02-11

Last Updated

2026-03-11

Healthy Volunteers

Conditions

Prostatic Neoplasms

Interventions

DRUG

177Lu-PSMA-617

administered intravenously once every 6 weeks (1 cycle) for 6 cycles

DRUG

68Ga-PSMA-11

Intravenous dose of approx. 150 Megabecquerel (MBq) at screening and at time of centrally confirmed rPD

DRUG

ARDT

Administered orally on a continuous basis as per package insert and guideline

DRUG

ADT

ADT are administered as per physician order

Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study 2. Patients must be adults ≥18 years of age 3. Patients must have an ECOG performance status of 0 to 2 4. Patients must have a life expectancy \>9 months as determined by the study investigator 5. Patients must have metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic site) 6. Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan, and eligible as determined by the sponsor's central reader 7. Patients must have at least one documented metastatic bone and/or soft tissue/visceral lesion documented in the following manners within 28 days prior randomization: 1. Metastatic disease to the bone (in any distribution) visible on 99Tc-MDP bone scintigraphy on either pre-ADT scans or baseline scans AND/OR 2. Lymph node metastases of any size or distribution. If lymph nodes are the only site of metastasis, then at least one must be at least 1.5 cm in short axis AND outside of the pelvis AND/OR 3. Visceral metastases of any size or distribution. If a participant has a history of visceral metastases at any time prior to randomization, he should be coded as having visceral metastases at baseline (i.e., patients with visceral metastases prior to ADT that disappear at baseline will be counted as having visceral metastases and would therefore have high volume disease for stratification purposes). 8. Patients must have adequate organ function: * Bone marrow reserve ANC ≥1.5 x 109/L Platelets ≥100 x 109/L Hemoglobin ≥9 g/dL * Hepatic Total bilirubin ≤2 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤3 x ULN is permitted Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases * Renal eGFR ≥ 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation 9. Albumin ≥2.5 g/dL 10. Human immunodeficiency virus (HIV)-infected patients who are healthy and have a low risk of acquired immune deficiency syndrome (AIDS)-related outcomes can participate in this trial 11. Patients must be: Treatment naïve OR minimally treated with: * Up to 45 days of luteinizing hormone-releasing hormone (LHRH) agonist /antagonists or bilateral orchiectomy with or without first generation anti-androgen (e.g. bicalutamide, flutamide) for metastatic prostate cancer is allowed prior to ICF signature. If given, first generation anti-androgen must be discontinued prior to start of study therapy or after 45 days whatever happens first. * If received, prior LHRH agonist/antagonist with or without first generation anti-androgen use in the adjuvant/neo-adjuvant setting must have been discontinued \> 12 months prior to ICF signature AND must not have exceeded 24 months of therapy AND must not have shown disease progression within 12 months of completing adjuvant/neo-adjuvant therapy. * Up to 45 days of CYP17 inhibitor or ARDT exposure for metastatic prostate cancer is allowed prior to ICF signature. No CYP17 inhibitor or ARDT exposure for earlier stages of prostate cancer is allowed. Exclusion Criteria: Participants meeting any of the following criteria are not eligible for inclusion in this study. 1. Participants with rapidly progressing tumor that requires urgent exposure to taxane-based chemotherapy 2. Any prior systemic anti-prostate cancer therapy (with the exception of the drugs listed on inclusion criteria 11), including chemotherapy, Poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors, immunotherapy or biological therapy (including monoclonal antibodies). 3. Concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy or investigational therapy 4. Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed 5. Ongoing participation in any other clinical trial 6. Use of other investigational drugs within 30 days prior to day of randomization 7. Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes 8. Transfusion for the sole purpose of making a participant eligible for study inclusion 9. Participants with CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Participants with epidural disease, canal disease and prior cord involvement are allowed if those areas have been treated, are stable, and not neurologically impaired. Participants with parenchymal CNS metastasis (or a history of CNS metastasis), that have received prior therapy and are neurologically stable, asymptomatic and not receiving steroids for CNS metastases, are allowed, baseline and subsequent radiological imaging must include evaluation of the brain (magnetic resonance imaging (MRI) preferred or CT with contrast). 10. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free, treatment free for more than 3 years prior to randomization, or participants with adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible. 11. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. Participants with an active documented COVID-19 infection (any grade of disease severity) at time of informed consent may be included only when completely recovered (in accordance with local guidance). 12. Active clinically significant cardiac disease defined as any of the following: * NYHA class 3/4 congestive heart failure within 6 months prior to ICF signature unless treated with improvement and echocardiogram or MUGA demonstrates EF \> 45% with improvement in symptoms to class \< 3. * History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants in the study such as: Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third degree AV block) * History of familial long QT syndrome or known family history of Torsades de Pointes * Cardiac or cardiac repolarization abnormality, including any of the following: History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature 13. History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study 14. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression 15. Any condition that precludes raised arms position 16. Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed. 17. Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF

Locations (166)

Mayo Clinic - Arizona Mayo Clinic Hospital

Scottsdale, Arizona, United States

Mayo Clinic Arizona

Scottsdale, Arizona, United States

University of California San Diego - Moores Cancer Center

La Jolla, California, United States

VA Greater LA Healthcare System

Los Angeles, California, United States

University of California LA

Los Angeles, California, United States

St. Joseph Hospital

Orange, California, United States

Univ Cali Irvine ALS Neuromuscular

Orange, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Sansum Clinic

Santa Barbara, California, United States

Providence Saint Johns Health Ctr

Santa Monica, California, United States

Univ Of Color Anschutz Med Center

Aurora, Colorado, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Georgetown University-Lombardi Cancer Center

Washington D.C., District of Columbia, United States

VA Medical Center

Washington D.C., District of Columbia, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

University Of Miami

Miami, Florida, United States

Miami Cancer Institute at Bapt

Miami, Florida, United States

Florida Cancer Affiliates

Panama City, Florida, United States

University Cancer and Blood Center LLC

Athens, Georgia, United States

The Queens Medical Centre

Honolulu, Hawaii, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Hines VA Hospital

Hines, Illinois, United States

Parkview Research Center

Fort Wayne, Indiana, United States

Indiana University

Indianapolis, Indiana, United States

Tulane Cancer Center

New Orleans, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Sidney Kimmel CCC At JH

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Uni Of Michigan Health System

Ann Arbor, Michigan, United States

Corewell Health William Beaum Hosp

Royal Oak, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Mississippi Med Ctr

Jackson, Mississippi, 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

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Urology Cancer Center PC

Omaha, Nebraska, United States

University of New Mexico

Albuquerque, New Mexico, United States

Weill Cornell Medical College

New York, New York, United States

Memorial Sloan Kettering Cancer Ctr

New York, New York, United States

Univ Of Rochester Cancer Ctr

Rochester, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke Univ Medical Center

Durham, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Oregon Health Sciences University

Portland, Oregon, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Thomas Jefferson Univ Hosp

Philadelphia, Pennsylvania, United States

Univ of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Dallas VA Medical Center

Dallas, Texas, United States

Texas Oncology

Dallas, Texas, United States

Univ of Texas Southwest Med Center

Dallas, Texas, United States

MD Anderson

Houston, Texas, United States

UT Health Science Center

Houston, Texas, United States

UT Health San Antonio Mays Cancer Center

San Antonio, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Onco Hemato Asso of SW Virginia

Roanoke, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

Novartis Investigative Site

Innsbruck, Tyrol, Austria

Novartis Investigative Site

Linz, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Ghent, Belgium

Novartis Investigative Site

Vancouver, British Columbia, Canada

Novartis Investigative Site

Hamilton, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Sherbrooke, Quebec, Canada

Novartis Investigative Site

Nanjing, Jiangsu, China

Novartis Investigative Site

Nanjing, Jiangsu, China

Novartis Investigative Site

Xian, Shanxi, China

Novartis Investigative Site

Chengdu, Sichuan, 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

Olomouc, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Copenhagen, Denmark

Novartis Investigative Site

Bordeaux, France

Novartis Investigative Site

Clermont-Ferrand, France

Novartis Investigative Site

Lyon, France

Novartis Investigative Site

Montpellier, France

Novartis Investigative Site

Nantes, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Strasbourg, France

Novartis Investigative Site

Vandœuvre-lès-Nancy, France

Novartis Investigative Site

Villejuif, France

Novartis Investigative Site

Würzburg, Bavaria, Germany

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

München, Germany

Novartis Investigative Site

Münster, Germany

Novartis Investigative Site

Rostock, Germany

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Novartis Investigative Site

Yokohama, Kanagawa-ku, Japan

Novartis Investigative Site

Suita, Osaka, Japan

Novartis Investigative Site

Kitaadachi-gun, Saitama, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Chuo Ku, Tokyo, 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

Kumamoto, Japan

Novartis Investigative Site

Kyoto, Japan

Novartis Investigative Site

Okayama, Japan

Novartis Investigative Site

Yamagata, Japan

Novartis Investigative Site

Nijmegen, Gelderland, Netherlands

Novartis Investigative Site

Maastricht, Limburg, Netherlands

Novartis Investigative Site

Delft, South Holland, Netherlands

Novartis Investigative Site

Utrecht, Netherlands

Novartis Investigative Site

Gliwice, Silesian Voivodeship, Poland

Novartis Investigative Site

Krakow, Poland

Novartis Investigative Site

Warsaw, Poland

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Novartis Investigative Site

Sabadell, Barcelona, Spain

Novartis Investigative Site

Majadahonda, Madrid, Spain

Novartis Investigative Site

El Palmar, Murcia, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Gothenburg, Sweden

Novartis Investigative Site

Lund, Sweden

Novartis Investigative Site

Stockholm, Sweden

Novartis Investigative Site

Bern, Switzerland

Novartis Investigative Site

Lausanne, Switzerland

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taoyuan District, Taiwan

Novartis Investigative Site

Sutton, Surrey, United Kingdom

Novartis Investigative Site

Belfast, United Kingdom

Novartis Investigative Site

Cambridge, United Kingdom

Novartis Investigative Site

Glasgow, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

Middlesbrough, United Kingdom

Clinical Research Directory

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (166)