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Promising new combo therapy for advanced prostate cancer enters final testing phase

NCT ID NCT04720157

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a targeted radiation drug (177Lu-PSMA-617) to standard hormone therapy can help men whose prostate cancer has spread but still responds to hormones. About 1,140 men are taking part. The goal is to see if the combination slows cancer growth and extends life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,140 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostatic neoplasms

Contacts and locations

Locations

  • Baptist Health South

    Miami, Florida, 33173, United States

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256, United States

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Corewell Health William Beaum Hosp

    Royal Oak, Michigan, 48073-6769, United States

  • Dallas VA Medical Center

    Dallas, Texas, 75216, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609, United States

  • Duke Univ Medical Center

    Durham, North Carolina, 27710, United States

  • Florida Cancer Affiliates

    Panama City, Florida, 32405, United States

  • Georgetown University-Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Hines VA Hospital

    Hines, Illinois, 60141, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Levine Cancer Institute

    Charlotte, North Carolina, 28203, United States

  • MD Anderson

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic - Arizona Mayo Clinic Hospital

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Ctr

    New York, New York, 10065, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    Linz, 4020, Austria

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 5C2, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H2W 1T8, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1, Canada

  • Novartis Investigative Site

    Québec, Quebec, G1R 2J6, Canada

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210006, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029, China

  • Novartis Investigative Site

    Xian, Shanxi, 710032, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Beijing, 100036, China

  • Novartis Investigative Site

    Guangzhou, 510060, China

  • Novartis Investigative Site

    Shanghai, 200025, China

  • Novartis Investigative Site

    Shanghai, 200032, China

  • Novartis Investigative Site

    Shanghai, 200080, China

  • Novartis Investigative Site

    Tianjin, 300300, China

  • Novartis Investigative Site

    Olomouc, 779 00, Czechia

  • Novartis Investigative Site

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    Copenhagen, DK-2100, Denmark

  • Novartis Investigative Site

    Bordeaux, 33075, France

  • Novartis Investigative Site

    Clermont-Ferrand, 63011, France

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Montpellier, 34298, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75015, France

  • Novartis Investigative Site

    Paris, 75018, France

  • Novartis Investigative Site

    Strasbourg, 67000, France

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511, France

  • Novartis Investigative Site

    Villejuif, 94800, France

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    München, 80377, Germany

  • Novartis Investigative Site

    Münster, 48149, Germany

  • Novartis Investigative Site

    Rostock, 18057, Germany

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4668560, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236-0004, Japan

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-8556, Japan

  • Novartis Investigative Site

    Suita, Osaka, 565-0871, Japan

  • Novartis Investigative Site

    Kitaadachi-gun, Saitama, 3620806, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 1040045, Japan

  • Novartis Investigative Site

    Chiba, 260-8717, Japan

  • Novartis Investigative Site

    Fukuoka, 811-0213, Japan

  • Novartis Investigative Site

    Fukuoka, 812-0033, Japan

  • Novartis Investigative Site

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    Fukushima, 9601295, Japan

  • Novartis Investigative Site

    Kyoto, 6068507, Japan

  • Novartis Investigative Site

    Okayama, 7008558, Japan

  • Novartis Investigative Site

    Yamagata, 990-9585, Japan

  • Novartis Investigative Site

    Nijmegen, Gelderland, 6500HB, Netherlands

  • Novartis Investigative Site

    Maastricht, Limburg, 6229 HX, Netherlands

  • Novartis Investigative Site

    Delft, South Holland, 2625 AD, Netherlands

  • Novartis Investigative Site

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    Gliwice, Silesian Voivodeship, 44-101, Poland

  • Novartis Investigative Site

    Krakow, 30-688, Poland

  • Novartis Investigative Site

    Warsaw, 02-781, Poland

  • Novartis Investigative Site

    Singapore, 119228, Singapore

  • Novartis Investigative Site

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208, Spain

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222, Spain

  • Novartis Investigative Site

    El Palmar, Murcia, 30120, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Madrid, 28046, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Gothenburg, 413 45, Sweden

  • Novartis Investigative Site

    Lund, 221 85, Sweden

  • Novartis Investigative Site

    Stockholm, 17176, Sweden

  • Novartis Investigative Site

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    Lausanne, 1011, Switzerland

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    Belfast, BT9 7AB, United Kingdom

  • Novartis Investigative Site

    Cambridge, CB2 0QQ, United Kingdom

  • Novartis Investigative Site

    Glasgow, G12 0YN, United Kingdom

  • Novartis Investigative Site

    London, EC1A 7BE, United Kingdom

  • Novartis Investigative Site

    London, NW1 2BU, United Kingdom

  • Novartis Investigative Site

    London, NW3 2QG, United Kingdom

  • Novartis Investigative Site

    Middlesbrough, TS4 3BW, United Kingdom

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Onco Hemato Asso of SW Virginia

    Roanoke, Virginia, 24014, United States

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Parkview Research Center

    Fort Wayne, Indiana, 46845, United States

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Providence Saint Johns Health Ctr

    Santa Monica, California, 90404, United States

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Sansum Clinic

    Santa Barbara, California, 93105, United States

  • Sidney Kimmel CCC At JH

    Baltimore, Maryland, 21231, United States

  • St Louis University

    St Louis, Missouri, 63104, United States

  • St. Joseph Hospital

    Orange, California, 92686, United States

  • Stanford University Medical Center

    Palo Alto, California, 94304, United States

  • Swedish Medical Center

    Seattle, Washington, 98122-4379, United States

  • Texas Oncology

    Amarillo, Texas, 79124, United States

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43221, United States

  • The Queens Medical Centre

    Honolulu, Hawaii, 96813, United States

  • Thomas Jefferson Univ Hosp

    Philadelphia, Pennsylvania, 19107, United States

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112, United States

  • UT Health San Antonio Mays Cancer Center

    San Antonio, Texas, 78229, United States

  • UT Health Science Center

    Houston, Texas, 77030, United States

  • Uni Of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • Univ Cali Irvine ALS Neuromuscular

    Orange, California, 92868, United States

  • Univ Of Color Anschutz Med Center

    Aurora, Colorado, 80045, United States

  • Univ Of Rochester Cancer Ctr

    Rochester, New York, 14642, United States

  • Univ of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232, United States

  • Univ of Texas Southwest Med Center

    Dallas, Texas, 75390-9034, United States

  • University Cancer and Blood Center LLC

    Athens, Georgia, 30607, United States

  • University Of Miami

    Miami, Florida, 33136, United States

  • University of California LA

    Los Angeles, California, 90095, United States

  • University of California San Diego - Moores Cancer Center

    La Jolla, California, 92093-0658, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Mississippi Med Ctr

    Jackson, Mississippi, 39216, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131 0001, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • Urology Cancer Center PC

    Omaha, Nebraska, 68130, United States

  • VA Greater LA Healthcare System

    Los Angeles, California, 90073, United States

  • VA Medical Center

    Washington D.C., District of Columbia, 20422, United States

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304-1207, United States

  • VA St Louis Health Care System

    St Louis, Missouri, 63106, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • Wash U School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College

    New York, New York, 10021, United States

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