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AzTrials

Metastatic Castrate Resistant Prostate Cancer (mCRPC)Phase 4RADIANTNCT04597125

RADIANT: A Study of Radium-223 Dichloride (Xofigo) vs Enzalutamide or Abiraterone (ARPIs, Androgen Receptor Pathway Inhibitors) in Patients With Prostate Cancer That Has Spread to the Bones (mCRPC, Metastatic Castration-Resistant Prostate Cancer)

A Phase 4 study testing Radium-223 dichloride (Xofigo, BAY88-8223) and ARPI therapy in people with Metastatic Castrate Resistant Prostate Cancer (mCRPC), run by Bayer at 117 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and androgen receptor pathway inhibitor (ARPI) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of ARPI therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Radium-223 dichloride (Xofigo, BAY88-8223) and ARPI therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
654 participants
Where
117 sitesin 19 countries
Study dates
9 Nov 2020to 19 Nov 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
Show all 28Show fewer
  • 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.

Trial locations and contacts

117 sites in 19 countries.

117 sites in 19 countries

Turkey (Türkiye)19 sites

  • Baskent Universitesi Seyhan Hastanesi

    Adana, 1250

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230

  • Ankara Yildirim Beyazit Universitesi Tip Fakültesi

    Ankara, 6050

  • Ankara Universitesi Tip Fakultesi Hastanesi

    Ankara, 6100

  • Trakya Univ. Tip Fak.

    Edirne, 22030

  • Gaziantep Universitesi Tip Fakultesi

    Gaziantep, 27070

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    Istanbul, 34093

  • Istanbul Egitim ve Arastirma Hastanesi

    Istanbul, 34098

  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

    Istanbul, 34722

  • Medipol Universitesi Tip Fakultesi

    Istanbul, 34810

  • Marmara University Medical Faculty | Pediatric Nephrology

    Istanbul, 34899

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

  • Izmir Tepecik Egitim ve Arastirma Hastanesi

    Izmir, 35180

  • Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi

    Izmir, 35330

  • Izmir Ekonomi Universitesi Medikal Point Hastanesi

    Izmir, 35575

  • Erciyes Universitesi Tip Fakultesi

    Kayseri, 38039

  • Mersin Universitesi Tip Fakultesi

    Mersin, 33079

  • Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi

    Samsun, 55139

Other trials in Turkey (Türkiye)

Spain16 sites

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

    A Coruña, 15009

  • Hospital Germans Trias I Pujol | Oncologia

    Badalona, Barcelona, 08916

  • Hospital Universitari Vall D Hebron | Oncologia

    Barcelona, 08035

  • Hospital De La Santa Creu I Sant Pau | Oncologia

    Barcelona, 8041

  • Hospital Universitario Puerta Del Mar | Oncologia

    Cadiz, 11009

  • Hospital General Universitario De Castellon | Oncologia

    Castellon, Castellón, 12002

  • Institut Catala D'oncologia | Girona | Oncologia

    Girona, Catalonia, 17007

  • Hospital Universitario De Jaen | Oncologia

    Jaén, 23007

  • Hospital Universitario Lucus Augusti | Oncologia

    Lugo, 27003

  • Hospital Universitario 12 De Octubre | Oncologia

    Madrid, Madrid, 28041

  • Hospital Universitario Puerta De Hierro De Majadahonda | Oncologia

    Majadahonda, Madrid, 28222

  • Hospital Universitario Virgen De La Victoria | Oncologia

    Málaga, 29010

  • Hospital Universitario Central De Asturias | Oncologia

    Oviedo, Principality of Asturias, 33011

  • University Hospital Son Espases | Oncologia

    Palma de Mallorca, Balearic Islands, 7120

  • Complexo Hospitalario Universitario De Santiago | Oncologia

    Santiago de Compostela, A Coruña, 15706

  • Fundacion Instituto Valenciano De Oncologia | Oncologia

    Valencia, 46009

Other trials in Spain

France13 sites

  • CHU de Bordeaux - Hopital Saint Andre

    Bordeaux, New Aquitaine, 33000

  • Hôpital Morvan - Brest

    Brest, Brittany Region, 29470

  • Centre de Lutte Contre le Cancer François Baclesse

    Caen, Normandy, 14076

  • Hôpital Henri Mondor

    Créteil, Île-de-France Region, 94010

  • Unicancer Dijon - Centre Georges Francois Leclerc

    Dijon, Bourgogne-Franche-Comté, 21079

  • Centre Hospitalier Universitaire - Grenoble

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

  • Unicancer Marseille - Institut Paoli-Calmettes

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

  • Centre Antoine Lacassagne Nice

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

  • Institut de Cancerologie Jean Godinot

    Reims, Grand Est, 51726

  • Centre Eugène Marquis - Rennes Cedex

    Rennes, Brittany Region, 35062

  • CHU Strasbourg - Hopital Hautepierre

    Strasbourg, Grand Est, 67200

  • Institut de Cancérologie de Lorraine - Alexis Vautrin

    Vandœuvre-lès-Nancy, Grand Est, 54519

  • Gustave Roussy - Departement Oncologie-Radiotherapie

    Villejuif, Île-de-France Region, 94805

Other trials in France

Australia11 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Icon Cancer Care

    Brisbane, Queensland, 4101

  • Specialist Services Medical Group

    Castle Hill, New South Wales, 2154

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • North West Cancer Centre

    North Tamworth, New South Wales, 2340

  • Tasman Health Care

    Southport, Queensland, 4215

  • Northern Cancer Institute

    St Leonards, New South Wales, 2065

  • Prince of Wales Hospital NSW

    Sydney, New South Wales, 2031

  • The Tweed Hospital

    Tugun, Queensland, 4224

  • Illawarra Shoalhaven Local Health District

    Wollongong, New South Wales, 2500

Other trials in Australia

Italy10 sites

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

    Alessandria, Piedmont, 15121

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

    Aviano, Friuli Venezia Giulia, 33081

  • University Hospital Of Ferrara - Oncologia Clinica

    Ferrara, Emilia-Romagna, 44124

  • Ente Ospedaliero Ospedali Galliera Di Genova - Oncologia Medica

    Genoa, Liguria, 16128

  • Istituto Europeo di Oncologia s.r.l

    Milan, Lombardy, 20141

  • Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia

    Modena, Emilia-Romagna, 41124

  • Istituto Oncologico Veneto_Padova - UOC Oncologia 1

    Padova, Veneto, 35128

  • Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica

    Parma, Emilia-Romagna, 43126

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

    Rome, Lazio, 00168

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

    Trento, Trentino-Alto Adige / Südtirol, 38122

Other trials in Italy

Czechia7 sites

  • Fakultní nemocnice u sv. Anny v Brně

    Brno, South Moravian, 656 91

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

    Chomutov, Ústí nad Labem Region, 430 12

  • Krajská nemocnice Liberec, a. s.

    Liberec, Liberec Region, 460 63

  • Urocentrum Praha, s.r.o.

    Prague, Prague, 120 00

  • Všeobecná fakultní nemocnice v Praze

    Prague, Prague, 128 08

  • Fakultni Thomayerova Nemocnice

    Prague, Prague, 140 59

  • Fakultní nemocnice Bulovka

    Prague, Prague, 180 81

Other trials in Czechia

Poland5 sites

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

    Koszalin, West Pomeranian Voivodeship, 75-851

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

    Krakow, Lesser Poland Voivodeship, 31-115

  • Scanmed SA ZOZ Gastromed

    Lublin, Lublin Voivodeship, 20-582

  • Szpital Grochowski im. dr.med. Rafała Masztaka

    Warsaw, Masovian Voivodeship, 04-073

  • Uniwersytecki Szpital Kliniczny UM we Wroclawiu

    Wroclaw, Lower Silesian Voivodeship, 50-556

Other trials in Poland

South Korea5 sites

  • Seoul National University Bundang Hospital | Urology

    Bundang-gu, Gyeonggi-do, 13620

  • National Cancer Center | Urologic Oncology

    Gyeonggi-do, 10408

  • Seoul National University Hospital | Urology

    Seoul, 03080

  • Asan Medical Center | Oncology

    Seoul, 05505

  • Seoul St Mary's Hospital | Urology

    Seoul, 06591

Other trials in South Korea

Taiwan5 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807377

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, 33305

Other trials in Taiwan

Finland4 sites

  • OBSOLETE_Docrates Klinikka

    Helsinki, Uusimaa, 00180

  • Oulu University Hospital, Oulun yliopistollinen sairaala (OYS)

    Oulu, North Ostrobothnia, 90220

  • Seinäjoen keskussairaala

    Seinäjoki, South Ostrobothnia, 60220

  • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)

    Tampere, Pirkanmaa, 33520

Other trials in Finland

Hong Kong4 sites

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan, Hong Kong Island, 00000

  • Prince of Wales Hospital

    Hong Kong, Hong Kong SAR, 00000

  • Queen Mary Hospital

    Hong Kong, Hong Kong SAR, 00000

  • Tuen Mun Hospital

    Tuenmen, Hong Kong Island, 00000

Other trials in Hong Kong

Lithuania4 sites

  • The Hospital of Lithuanian University of Health SciencesLUHS

    Kaunas, Kaunas County, LT-50009

  • PI Klaipedos University Hospital

    Klaipėda, Klaipėda County, LT-92288

  • National Cancer Institute

    Vilnius, Vilnius County, LT-08660

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, Vilnius County, LT-08661

Other trials in Lithuania

Austria2 sites

  • Kepler Universitätsklinikum GmbH

    Linz, Upper Austria, 4020

  • Klinik Ottakring, Wilhelminenspital

    Vienna, Lower Austria, 3500

Other trials in Austria

Germany2 sites

  • Universitätsmedizin der Johannes Gutenberg, Universität Mainz

    Mainz, Rhineland-Palatinate, 55101

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Hungary2 sites

  • Semmelweis University

    Budapest, 1083

  • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz

    Szolnok, Jász-Nagykun-Szolnok, 5000

Other trials in Hungary

Israel2 sites

  • Carmel Medical Center

    Haifa, 3436212

  • Tel- Aviv Sourasky Medical Center - Nephrology

    Tel Aviv, 6423906

Other trials in Israel

Russia2 sites

  • Chelyabinsk Regional Oncology Dispensary

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • National Medical Research Radiology Center

    Obninsk, Kaluga Oblast, 249036

Other trials in Russia

Singapore2 sites

  • National Cancer Center Singapore - Oncology Department

    Singapore, 168583

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

United Kingdom2 sites

  • Beatson West of Scotland Cancer Centre | Clinical Trials Unit

    Glasgow, Scotland, G12 0YN

  • Royal Berkshire Hospital | Oncology

    Reading, Berkshire, RG1 5AN

Other trials in United Kingdom

About this study

Official title: A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of ARPI

Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and androgen receptor pathway inhibitor (ARPI) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of ARPI therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and ARPI therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The ARPI drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer.

Participants in this study will receive either Radium-223 dichloride or a ARPI therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral ARPI therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.

Being tested
Radium-223 dichloride (Xofigo, BAY88-8223), ARPI therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radium-223 dichloride (Xofigo, BAY88-8223)Drug

    Participants will receive Radium-223 (BAY88-8223) every 4 weeks for a total of 6 administrations via intravenous (IV) injection

  • ARPI therapyDrug

    Also called Second ARPI

    Participants will receive continuous ARPI (either Abiraterone acetate plus prednisone/prednisolone [AAP] or enzalutamide) by mouth (per os) daily

Study groups in NCT04597125
Study groupRoleWhat they receive
Arm AExperimentalParticipants with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of ARPI will be randomized to receive radium-223 dichloride
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Arm BActive comparatorParticipants with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of ARPI will be randomized to receive second ARPI
Receives: Drug: ARPI therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Measured: Up to five years

Secondary outcomes (6)

  1. Time to first symptomatic skeletal event (SSE)

    Measured: Up to five years

  2. Radiological Progression-free survival (rPFS)

    rPFS is defined as the time from the date of randomization to the date of confirmed radiological progression or death, whichever occurs first.

    Measured: Up to five years

  3. Time to pain progression (BPI-SF)

    The Brief Pain Inventory-Short Form (BPI-SF) is a self-administered questionnaire with 11 items designed to evaluate the intensity of, and the impairment caused by pain. Four items measure pain intensity using 0 ("no pain") to 10 ("pain as bad as you can imagine") numeric rating scales, and 7 items measure the level of interference with function caused by pain using 0 (no interference) to 10 (complete interference) rating scales.

    Measured: Up to five years

  4. Adverse events assessments using NCI CTCAE (v5.0)

    Measured: After first administration of study intervention up to 30 days after the last dose of study intervention

  5. Incidence of fractures

    Measured: Up to five years

  6. Time to deterioration of FACT-P total score

    The FACT-P questionnaire assesses prostate cancer-related quality of life. The FACT-P total score is the sum of the scores of 39 items of the questionnaire and ranges from 1 to 156, the higher the score, the better the quality of life of prostate cancer patients.

    Measured: Up to five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start9 Nov 2020
  3. Primary completion21 Nov 2025
  4. Study completion19 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
654 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04597125
Sponsor's protocol ID
20510
Other IDs
2023-505830-89-00, 2019-000476-42, 2019, 2023
Acronym
RADIANT
Status last verified
11 Aug 2026
First submitted
16 Oct 2020
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Radium-223 dichloride (Xofigo, BAY88-8223) and ARPI therapy in people with Metastatic Castrate Resistant Prostate Cancer (mCRPC), run by Bayer at 117 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in Turkey (Türkiye), Spain, France, Australia, Italy and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: Up to five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04597125.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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