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New hope for advanced prostate cancer: radioactive drug vs standard therapy

NCT ID NCT04597125

Disease control Sponsor: Bayer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Updated 2 times

Summary

This study tests whether a radioactive drug called radium-223 works better than standard hormone-blocking pills (ARPI) for men with prostate cancer that has spread to the bones and is no longer responding to initial hormone therapy. About 654 participants will receive either radium-223 injections or oral ARPI drugs. The main goal is to see which treatment helps people live longer and improves pain and quality of 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

654 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Oct 2026

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 years and older

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 who have histologically confirmed adenocarcinoma of the prostate. * Participants with mCRPC progressing on/after one line of an approved ARPI (eg. abiraterone, enzalutamide, apalutamide, or darolutamide, after being treated for at least 3 months) in an authorized prostate cancer indication. * One prior taxane treatment regimen (at least 2 cycles) for metastatic prostate cancer (mHSPC and mCRPC) or refusal or ineligibility of such a regimen. * Prostate cancer progression documented by PSA according to the Prostate Cancer Working Group 3 (PCWG3) criteria or radiological progression according to RECIST, version 1.1. * At least 2 bone metastases on bone scan within 4 weeks prior to randomization with no current or history of lung, liver, other visceral, and / or brain metastasis. * Symptomatic prostate cancer. A worst pain score (WPS) of at least 1 on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 (worst pain in last 24 hours). This is to be assessed once during the Screening period. * Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7 nmol/L). If the participant is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (participant who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study. * Participants must be on a BHA treatment, such as bisphosphonates or denosumab treatment unless such treatment is contraindicated or not recommended per investigator's judgement and inclusion is agreed to by the medical monitor. * Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. * Life expectancy ≥ 6 months. * Able to swallow abiraterone and prednisone/prednisolone or enzalutamide as whole tablets/capsules. * Laboratory requirements: * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L; 5.6 mmol/L) * Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (except for participants with documented Gilbert's disease) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN * Creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m\^2 as calculated using the Cockcroft-Gault equation * International normalized ratio (INR) of prothrombin time (PT; PT-INR) and partial thromboplastin time (PTT) ≤ 1.5 times the ULN. Participants treated with warfarin or heparin will be allowed to participate in the study if no underlying abnormality in coagulation parameters exists per prior history; weekly evaluation of PT-INR / PTT will be required until stability is achieved (as defined by local standard of care and based on pre-study PT-INR / PTT values) * Serum albumin \> 30 g/L * Serum potassium ≥ 3.5 mmol/L * Capable of giving signed informed consent Exclusion Criteria: * Active infection or other medical condition that would make prednisone / prednisolone (corticosteroid) use contraindicated. * Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone / prednisolone equivalent daily for more than 2 months. * Pathological finding consistent with tumors with predominant neuroendocrine features or small cell carcinoma of the prostate. * History of osteoporotic fracture * History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations. * History of or known brain metastasis. * Malignant lymphadenopathy exceeding 3 cm in short-axis diameter. * Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer) * Imminent spinal cord compression based on clinical findings and / or magnetic resonance imaging (MRI). Participants with history of spinal cord compression should have completely recovered. * Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg). Participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment. * Active or symptomatic viral hepatitis * History of pituitary or adrenal dysfunction * Any other serious illness or medical condition such as, but not limited to: * Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 Grade 2 * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II to IV heart disease or cardiac ejection fraction measurement of \<50% at baseline * Current clinical evidence of any uncontrolled cardiac arrhythmia * Crohn's disease or ulcerative colitis * Bone marrow dysplasia * Moderate and severe hepatic impairment (Child-Pugh Classes B and C) * Unmanageable fecal incontinence. * Any condition, which in the opinion of the investigator would preclude participation in this trial (eg, history of seizure). * Hypersensitivity to the active substances or to any excipients of radium-223 dichloride, or abiraterone acetate or enzalutamide. * Prior therapeutic systemic radiation with any radiopharmaceutical medication for the treatment of prostate cancer, including but not limited to lutetium-177, strontium-89, samarium-153, iodine-131, rhenium-186, rhenium-188, or radium-223. Radiopharmaceutical compounds used for diagnosis purposes only are allowed. * Prior hemibody external radiotherapy is excluded. Participants who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for Hb, ANC, and platelet count. * Blood transfusion or erythropoietin stimulating agents 4 weeks prior to Screening and during the whole Screening period before randomization. * Excessive intake of biotin above the recommended daily dose of 30 μg. Biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth at levels that may interfere with laboratory tests. * Prior administration of an investigational therapeutic for CRPC. * Previous (within the last 4 weeks of randomization) or concurrent participation in any interventional clinical study with investigational study drug administration.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

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

Metastatic castrate-resistant prostate cancer (MCRPC)

Contacts and locations

Locations

  • Ankara Universitesi Tip Fakultesi Hastanesi

    Ankara, 6100, Turkey (Türkiye)

  • Ankara Yildirim Beyazit Universitesi Tip Fakültesi

    Ankara, 6050, Turkey (Türkiye)

  • Asan Medical Center | Oncology

    Seoul, 05505, South Korea

  • Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica

    Parma, Emilia-Romagna, 43126, Italy

  • Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia

    Modena, Emilia-Romagna, 41124, Italy

  • Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria_Presidio Civile - Oncologia

    Alessandria, Piedmont, 15121, Italy

  • Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia Medica

    Trento, Trentino-Alto Adige, 38122, Italy

  • Baskent Universitesi Seyhan Hastanesi

    Adana, 1250, Turkey (Türkiye)

  • CHU Strasbourg - Hopital Hautepierre

    Strasbourg, Grand Est, 67200, France

  • Centre Antoine Lacassagne

    Nice, Provence-Alpes-Côte d'Azur Region, 06189, France

  • Centre Eugène Marquis - Rennes Cedex

    Rennes, Brittany Region, 35062, France

  • Centre Hospitalier Universitaire - Grenoble

    La Tronche (Grenoble Area), Auvergne-Rhône-Alpes, 38700, France

  • Centre de Lutte Contre le Cancer François Baclesse

    Caen, Normandy, 14076, France

  • Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati

    Aviano, Friuli Venezia Giulia, 33081, Italy

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, 33305, Taiwan

  • Chelyabinsk Regional Oncology Dispensary

    Chelyabinsk, Chelyabinsk Oblast, 454087, Russia

  • Complexo Hospitalario Universitario De Santiago | Oncologia

    Santiago de Compostela, A Coruña, 15706, Spain

  • Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi

    Izmir, 35330, Turkey (Türkiye)

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100, Turkey (Türkiye)

  • Ente Ospedaliero Ospedali Galliera Di Genova - Oncologia Medica

    Genoa, Liguria, 16128, Italy

  • Erciyes Universitesi Tip Fakultesi

    Kayseri, 38039, Turkey (Türkiye)

  • Fakultni Thomayerova Nemocnice

    Prague, Prague, 140 59, Czechia

  • Fakultní nemocnice Bulovka

    Prague, Prague, 180 81, Czechia

  • Fakultní nemocnice u sv. Anny v Brne

    Brno, South Moravian, 656 91, Czechia

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Servizio di Radioterapia Oncologica

    Rome, Lazio, 00168, Italy

  • Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro | Oncologia

    A Coruña, 15009, Spain

  • Fundacion Instituto Valenciano De Oncologia | Oncologia

    Valencia, 46009, Spain

  • Gaziantep Universitesi Tip Fakultesi

    Gaziantep, 27070, Turkey (Türkiye)

  • Gosford Hospital

    Gosford, New South Wales, 2250, Australia

  • Gustave Roussy - Departement Oncologie-Radiotherapie

    Villejuif, Île-de-France Region, 94805, France

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230, Turkey (Türkiye)

  • Hong Kong Integrated Oncology Centre (HKIOC)

    Central, 0, Hong Kong

  • Hospital De La Santa Creu I Sant Pau | Oncologia

    Barcelona, 8041, Spain

  • Hospital General Universitario De Castellon | Oncologia

    Castellon, Castellón, 12002, Spain

  • Hospital Germans Trias I Pujol | Oncologia

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari Vall D Hebron | Oncologia

    Barcelona, 08035, Spain

  • Hospital Universitario 12 De Octubre | Oncologia

    Madrid, 28041, Spain

  • Hospital Universitario Central De Asturias | Oncologia

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario De Jaen | Oncologia

    Jaén, 23007, Spain

  • Hospital Universitario Lucus Augusti | Oncologia

    Lugo, 27003, Spain

  • Hospital Universitario Puerta De Hierro De Majadahonda | Oncologia

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Puerta Del Mar | Oncologia

    Cadiz, 11009, Spain

  • Hospital Universitario Virgen De La Victoria | Oncologia

    Málaga, 29010, Spain

  • Hôpital Henri Mondor

    Créteil, Île-de-France Region, 94010, France

  • Hôpital Morvan - Brest

    Brest, Brittany Region, 29470, France

  • Hôpital Saint André - Bordeaux

    Bordeaux, New Aquitaine, 33000, France

  • Icon Cancer Care

    Brisbane, Queensland, 4101, Australia

  • Illawarra Shoalhaven Local Health District

    Wollongong, New South Wales, 2500, Australia

  • Institut Catala D'oncologia | Girona | Oncologia

    Barcelona, 08908, Spain

  • Institut de Cancerologie Jean Godinot

    Reims, Grand Est, 51726, France

  • Institut de Cancérologie de Lorraine - Alexis Vautrin

    Vandœuvre-lès-Nancy, Grand Est, 54519, France

  • Istanbul Egitim ve Arastirma Hastanesi

    Istanbul, 34098, Turkey (Türkiye)

  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    Istanbul, 34093, Turkey (Türkiye)

  • Istituto Europeo di Oncologia s.r.l

    Milan, Lombardy, 20141, Italy

  • Istituto Oncologico Veneto_Padova - UOC Oncologia 1

    Padova, Veneto, 35128, Italy

  • Izmir Ekonomi Universitesi Medikal Point Hastanesi

    Izmir, 35575, Turkey (Türkiye)

  • Izmir Tepecik Egitim ve Arastirma Hastanesi

    Izmir, 35180, Turkey (Türkiye)

  • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz

    Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807377, Taiwan

  • Kepler Universitätsklinikum GmbH

    Linz, Upper Austria, 4020, Austria

  • Klinik Ottakring, Wilhelminenspital

    Vienna, Lower Austria, 3500, Austria

  • Krajska Zdravotní, a.s. - Nemocnice Chomutov, o.z. - Onkologické oddelení

    Chomutov, Ústí nad Labem Region, 430 12, Czechia

  • Krajská nemocnice Liberec, a. s.

    Liberec, Liberec Region, 460 63, Czechia

  • Lady Davis Carmel Medical Center

    Haifa, 3436212, Israel

  • Marmara University Medical Faculty | Pediatric Nephrology

    Istanbul, 34899, Turkey (Türkiye)

  • Medipol Universitesi Tip Fakultesi

    Istanbul, 34810, Turkey (Türkiye)

  • Mersin Universitesi Tip Fakultesi

    Mersin, 33079, Turkey (Türkiye)

  • NHS Greater Glasgow & Clyde | Beatson West of Scotland Cancer Centre - Clinical Research Unit

    Glasgow, Scotland, G12 0YN, United Kingdom

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

    Krakow, 31-115, Poland

  • National Cancer Center Singapore - Oncology Department

    Singapore, 168583, Singapore

  • National Cancer Center | Urologic Oncology

    Gyeonggi-do, 10408, South Korea

  • National Cancer Institute

    Vilnius, Vilnius County, LT-08660, Lithuania

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Medical Research Radiology Center

    Obninsk, Kaluga Oblast, 249036, Russia

  • Nepean Hospital

    Kingswood, New South Wales, 2747, Australia

  • North West Cancer Centre

    North Tamworth, New South Wales, 2340, Australia

  • Northern Cancer Institute

    St Leonards, New South Wales, 2065, Australia

  • OBSOLETE_Docrates Klinikka

    Helsinki, Uusimaa, 00180, Finland

  • Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi

    Samsun, 55139, Turkey (Türkiye)

  • Oulu University Hospital, Oulun yliopistollinen sairaala (OYS)

    Oulu, North Ostrobothnia, 90220, Finland

  • PI Klaipedos University Hospital

    Klaipėda, Klaipėda County, LT-92288, Lithuania

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan, Hong Kong Island, 00000, Hong Kong

  • Prince of Wales Hospital

    Hong Kong, Hong Kong SAR, 00000, Hong Kong

  • Prince of Wales Hospital NSW

    Sydney, New South Wales, 2031, Australia

  • Queen Mary Hospital

    Hong Kong, Hong Kong SAR, 00000, Hong Kong

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Berkshire NHS Foundation Trust¦Royal Berkshire Hospital - Oncology

    Reading, Berkshire, RG1 5AN, United Kingdom

  • Scanmed SA ZOZ Gastromed

    Lublin, 20-582, Poland

  • Seinäjoen keskussairaala

    Seinäjoki, South Ostrobothnia, 60220, Finland

  • Semmelweis University

    Budapest, 1083, Hungary

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • Singapore General Hospital

    Singapore, 169608, Singapore

  • Specialist Services Medical Group

    Castle Hill, New South Wales, 2154, Australia

  • Szpital Grochowski im. dr.med. Rafala Masztaka

    Warsaw, 04-073, Poland

  • Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie - Oddzial Dzienny Chemioterapii

    Koszalin, 75-851, Poland

  • TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

    Istanbul, 34722, Turkey (Türkiye)

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)

    Tampere, Pirkanmaa, 33520, Finland

  • Tasman Health Care

    Southport, Queensland, 4215, Australia

  • Tel- Aviv Sourasky Medical Center - Nephrology

    Tel Aviv, 6423906, Israel

  • The Hospital of Lithuanian University of Health SciencesLUHS

    Kaunas, Kaunas County, LT-50009, Lithuania

  • The Tweed Hospital

    Tugun, Queensland, 4224, Australia

  • Trakya Univ. Tip Fak.

    Edirne, 22030, Turkey (Türkiye)

  • Tuen Mun Hospital

    Tuenmen, Hong Kong Island, 00000, Hong Kong

  • Unicancer Dijon - Centre Georges Francois Leclerc

    Dijon, Bourgogne-Franche-Comté, 21079, France

  • Unicancer Marseille - Institut Paoli-Calmettes

    Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France

  • University Hospital Of Ferrara - Oncologia Clinica

    Ferrara, Emilia-Romagna, 44124, Italy

  • University Hospital Son Espases | Oncologia

    Palma de Mallorca, Balearic Islands, 7120, Spain

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitätsmedizin der Johannes Gutenberg, Universität Mainz

    Mainz, Rhineland-Palatinate, 55101, Germany

  • Uniwersytecki Szpital Kliniczny UM we Wroclawiu

    Wroclaw, 50-556, Poland

  • Urocentrum Praha, s.r.o.

    Prague, Prague, 120 00, Czechia

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT-08661, Lithuania

  • Všeobecná fakultní nemocnice v Praze

    Prague, Prague, 128 08, Czechia

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