do_not_disturb_altRecruitment Complete

metastatic castrate resistant prostate cancer (mCRPC)

Investigation of Radium-223 dichloride (Xofigo), a treatment that gives off radiation that helps kill cancer cells, compared to a treatment that inactivates hormones (new antihormonal therapy, NAH) in patients with prostate cancer that has spread to the bone getting worse on or after earlier NAH

Trial purpose

Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH 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 NAH 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 NAH 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 NAH 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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - Participants who have histologically confirmed adenocarcinoma of the prostate.

    - Participants with mCRPC progressing on/after one line of an approved NAH (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

  • - 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.

Trial summary

Enrollment Goal
696
Trial Dates
November 2020 - October 2026
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
The Hospital of Lithuanian University of Health SciencesLUHSKaunas, LT-50009, Lithuania
Completed
PI Klaipedos University HospitalKlaipeda, LT-92288, Lithuania
Completed
National Cancer InstituteVilnius, LT-08660, Lithuania
Completed
Vilnius University Hospital Santaros KlinikosVilnius, LT-08661, Lithuania
Withdrawn
Fakultní Nemocnice OlomoucOlomouc, 77900, Czech Republic
Active, not recruiting
Fakultni Thomayerova NemocnicePrague, 140 59, Czech Republic
Completed
Nemocnice Chomutov, o.z.Chomutov, 430 12, Czech Republic
Completed
Fakultní nemocnice BulovkaPraha 8, 180 81, Czech Republic
Active, not recruiting
Fakultni nemocnice u sv. AnnyBrno, 656 91, Czech Republic
Active, not recruiting
Urocentrum Praha, s.r.o.Praha 2, 120 00, Czech Republic
Active, not recruiting
Všeobecná fakultní nemocnice v PrazePraha 2, 12808, Czech Republic
Active, not recruiting
Krajska Nemocnice LiberecLiberec, 460 63, Czech Republic
Withdrawn
Edith Wolfson Medical Center | Internal Medicine DepartmentHolon, 5822012, Israel
Withdrawn
Hadassah Hebrew University Hospital Ein KeremJerusalem, 9112001, Israel
Withdrawn
Rambam Health CorporationHaifa, 3109601, Israel
Active, not recruiting
Lady Davis Carmel Medical CenterHaifa, 3436212, Israel
Active, not recruiting
Tel-Aviv Sourasky Medical CenterTel Aviv, 6423906, Israel
Active, not recruiting
Gustave Roussy - Departement Oncologie-RadiotherapieVILLEJUIF CEDEX, 94805, France
Completed
Dokuz Eylul Universitesi Tip FakultesiIzmir, 35100, Turkey
Withdrawn
Koc Universitesi Tip Fakultesi - RadyolojiIstanbul, 34010, Turkey
Active, not recruiting
Medipol Universitesi Tip FakultesiIstanbul, 34810, Turkey
Active, not recruiting
Izmir Tepecik Egitim ve Arastirma HastanesiIzmir, 35180, Turkey
Active, not recruiting
Gaziantep Universitesi Tip FakultesiGaziantep, 27070, Turkey
Completed
Istanbul Universitesi Istanbul Tip FakultesiIstanbul, 34093, Turkey
Active, not recruiting
Erciyes Universitesi Tip FakultesiKayseri, 38039, Turkey
Completed
Hacettepe Universitesi Tip FakultesiAnkara, 6100, Turkey
Active, not recruiting
Ege Universitesi Tip FakultesiIzmir, 35100, Turkey
Active, not recruiting
Baskent Universitesi Seyhan HastanesiAdana, 1250, Turkey
Completed
Ondokuz Mayis Uni Tip FakultesiSamsun, 55139, Turkey
Active, not recruiting
Marmara University Medical Faculty | Pediatric NephrologyIstanbul, 34899, Turkey
Active, not recruiting
Ankara Universitesi Tip Fakultesi HastanesiAnkara, 6100, Turkey
Completed
Ankara Yildirim Beyazit Universitesi Tip FakültesiANKARA, 6050, Turkey
Active, not recruiting
TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir HasISTANBUL, 34722, Turkey
Active, not recruiting
Trakya Univ. Tip Fak.Edirne, 22030, Turkey
Active, not recruiting
Consorcio Hospitalario Provincial de CastellónCastellón, 12002, Spain
Active, not recruiting
Hospital Universitari Son EspasesPalma De Mallorca, 7120, Spain
Active, not recruiting
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Withdrawn
Hospital Universitario Ramon y Cajal | Departamento de Medicina InternaMadrid, 28034, Spain
Active, not recruiting
Instituto Valenciano de OncologíaValencia, 46009, Spain
Completed
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Active, not recruiting
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Active, not recruiting
Hospital Universitario Clinica Puerta de HierroMajadahonda, 28222, Spain
Active, not recruiting
Hospital de la Santa Creu i Sant Pau | Gynecology DepartmentBarcelona, 8041, Spain
Active, not recruiting
Centro Oncológico de GaliciaA Coruña, 15009, Spain
Active, not recruiting
Asan Medical CenterSeoul, 05505, Korea,_republic_of
Completed
Seoul St. Mary's HospitalSeoul, 6591, Korea,_republic_of
Active, not recruiting
National Cancer CenterGoyang-si, 10408, Korea,_republic_of
Active, not recruiting
Seoul National University Bundang HospitalSeongnam-si, 13620, Korea,_republic_of
Completed
Seoul National University HospitalSeoul, 3080, Korea,_republic_of
Active, not recruiting
Queen Mary HospitalHong Kong, MISSING, Hong Kong
Active, not recruiting
Prince of Wales HospitalHong Kong, MISSING, Hong Kong
Active, not recruiting
Pamela Youde Nethersole Eastern HospitalChai Wan, Hong Kong
Active, not recruiting
Tuen Mun HospitalTBC, TBC, Hong Kong
Not yet recruiting
Hong Kong Integrated Oncology Centre (HKIOC)Central, Hong Kong
Withdrawn
Hong Kong Sanatorium & HospitalHong Kong, N/A, Hong Kong
Completed
Taipei Veterans General HospitalTaipei, 11217, Taiwan
Active, not recruiting
Chang Gung Memorial Hospital at LinkouTaoyuan, 33305, Taiwan
Active, not recruiting
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Active, not recruiting
National Cheng Kung University HospitalTainan, 704, Taiwan
Active, not recruiting
Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, 807377, Taiwan
Withdrawn
Rabin Medical Center | Beilinson Hospital - Internal Medicine C DepartmentPetah Tikva, 4941492, Israel
Completed
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip FakultesiIstanbul, 34098, Turkey
Active, not recruiting
Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia MedicaTrento, 38122, Italy
Active, not recruiting
Ente Ospedaliero Ospedali Galliera Di Genova - Oncologia MedicaGenova, 16128, Italy
Active, not recruiting
Azienda Ospedaliero Universitaria di Modena_Policlinico - OncologiaModena, 41124, Italy
Withdrawn
Azienda Ospedaliera S Maria Di TerniTerni, 6129, Italy
Active, not recruiting
Centro di Riferimento Oncologico di AvianoPordenone, 33081, Italy
Withdrawn
A.O.U. PisanaPisa, 56126, Italy
Active, not recruiting
Istituto Oncologico Veneto_Padova - UOC Oncologia 1Padova, 35128, Italy
Active, not recruiting
Azienda Ospedaliero Universitaria Parma - SC Oncologia MedicaParma, 43126, Italy
Completed
Istituto Europeo di Oncologia s.r.lMilano, 20141, Italy
Active, not recruiting
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria_Presidio Civile - OncologiaAlessandria, 15121, Italy
Active, not recruiting
University Hospital Of Ferrara - Oncologia ClinicaFerrara, 44124, Italy
Withdrawn
Azienda USL IRCCS di Reggio EmiliaReggio Emilia, 42123, Italy
Withdrawn
Azienda Ospedaliera Di Rilievo Nazionale Antonio CardarelliNapoli, 80131, Italy
Completed
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Servizio di Radioterapia OncologicaRoma, 00168, Italy
Completed
Beatson West of Scotland Cancer CentreGlasgow, G12 0YN, United Kingdom
Withdrawn
Royal Surrey County HospitalGuildford, GU2 7XX, United Kingdom
Withdrawn
Royal Preston HospitalPreston, PR2 4HT, United Kingdom
Active, not recruiting
Royal Berkshire NHS Foundation Trust¦Royal Berkshire Hospital - OncologyReading, RG1 5AN, United Kingdom
Completed
Mersin Universitesi Tip FakultesiMersin, 33079, Turkey
Active, not recruiting
Klinik Ottakring - WilhelminenspitalWien, 1160, Austria
Completed
Kepler Universitätsklinikum Campus IIILinz, 4020, Austria
Completed
Istanbul Egitim ve Arastirma HastanesiIstanbul, 34098, Turkey
Withdrawn
Clinique Sainte Marguerite - HyèresHYERES, 83400, France
Completed
Institut de Cancérologie de Lorraine - Alexis VautrinVandoeuvre-les-Nancy, 54519, France
Completed
Centre Georges Francois Leclerc DijonDIJON, 21079, France
Withdrawn
Centre Oscar Lambret - LilleLILLE CEDEX, 59020, France
Withdrawn
Institut Bergonié - Unicancer Nouvelle AquitaineBordeaux, 33076, France
Completed
Centre de Lutte Contre le Cancer François BaclesseCAEN CEDEX 5, 14076, France
Withdrawn
Hopital Jean MinjozBESANCON, 25030, France
Active, not recruiting
Centre Antoine LacassagneNICE CEDEX 2, 6189, France
Active, not recruiting
Centre Hospitalier Universitaire - Grenoblegrenoble, 38700, France
Active, not recruiting
Centre Eugène Marquis - Rennes CedexRENNES CEDEX, 35062, France
Active, not recruiting
Hôpital Henri MondorCreteil, 94010, France
Active, not recruiting
Hôpital Morvan - BrestBREST, 29470, France
Withdrawn
Centre Léon Bérardlyon, 69008, France
Completed
CHU Strasbourg - Hopital HautepierreStrasbourg, 67200, France
Active, not recruiting
Hôpital Saint André - BordeauxBORDEAUX, 33000, France
Withdrawn
Hopital BretonneauTours, 37044, France
Withdrawn
Institut du Cancer de Montpellier - Val d'AurelleMONTPELLIER CEDEX, 34298, France
Withdrawn
Centrum Onkologii im. Prof. Franciszka LukaszczykaBydgoszcz, 85-796, Poland
Active, not recruiting
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie - Oddzial Dzienny ChemioterapiiKoszalin, 75-851, Poland
Completed
Narodowy Instytut Onkologii im. Marii Sklodowskiej-CurieKrakow, 31-115, Poland
Active, not recruiting
Szpital Grochowski im. dr.med. Rafala MasztakaWarszawa, 04-073, Poland
Active, not recruiting
Uniwersytecki Szpital Kliniczny UM we WroclawiuWroclaw, 50-556, Poland
Active, not recruiting
Tampereen yliopistollinen sairaalaTampere, 33520, Finland
Withdrawn
Kuopion yliopistollinen sairaalaKuopio, 70210, Finland
Completed
Seinäjoen keskussairaalaSeinäjoki, 60220, Finland
Completed
Docrates KlinikkaHelsinki, 00180, Finland
Completed
Oulun yliopistollinen sairaalaOulu, 90220, Finland
Active, not recruiting
Singapore General HospitalSingapore, 169608, Singapore
Active, not recruiting
National Cancer Center SingaporeSingapore, 168583, Singapore
Completed
Semmelweis UniversityBudapest, 1083, Hungary
Withdrawn
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Withdrawn
Tolna Varmegyei Balassa Janos KorhazSzekszard, 7100, Hungary
Withdrawn
Magyar Honvedseg Egeszsegugyi KozpontBudapest, 1062, Hungary
Withdrawn
Clinical Oncological Dispensary of Omsk RegionOmsk, 644013, Russian Federation
Completed
Chelyabinsk Regional Oncology DispensaryChelyabinsk, 454087, Russia
Completed
National Medical Research Radiology CenterObninsk, 249036, Russia
Withdrawn
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMSMoscow, 115552, Russian Federation
Withdrawn
Samara Regional Clinical Oncology DispensarySamara, 443031, Russian Federation
Withdrawn
Tomsk National Research Medical Center of RASTomsk, 634009, Russian Federation
Active, not recruiting
Icon Cancer CareBrisbane, 4101, Australia
Active, not recruiting
Tasman Health CareSouthport, 4215, Australia
Active, not recruiting
Specialist Services Medical GroupCastle Hill, 2154, Australia
Active, not recruiting
Nepean HospitalKingswood, 2747, Australia
Active, not recruiting
Prince of Wales Hospital NSWSydney, 2031, Australia
Active, not recruiting
North West Cancer CentreNorth Tamworth, 2340, Australia
Active, not recruiting
Royal Adelaide HospitalAdelaide, 5000, Australia
Withdrawn
Calvary North Adelaide HospitalNorth Adelaide, 5006, Australia
Active, not recruiting
Illawarra Shoalhaven Local Health DistrictWollongong, 2500, Australia
Completed
The Tweed HospitalTugun, 4224, Australia
Active, not recruiting
Universitaetsklinikum MuensterMünster, 48149, Germany
Withdrawn
Urologische Gemeinschaftspraxis BremenBremen, 28277, Germany
Withdrawn
Universitätsklinikum Carl Gustav Carus DresdenDresden, 01307, Germany
Completed
Universitätsmedizin der Johannes Gutenberg Universität MainzMainz, 55101, Germany
Active, not recruiting
Institut de Cancerologie Jean GodinotReims, 51726, France
Active, not recruiting
Hospital Universitario Virgen de la Victoria | Cardiology DepartmentMalaga, 29010, Spain
Withdrawn
Institut Claudius Regaud - iUCT OncopoleTOULOUSE CEDEX 9, 31059, France
Active, not recruiting
Institut Paoli-Calmettes - MarseilleMARSEILLE, 13273, France
Completed
Northern Cancer InstituteSt Leonards, 2065, Australia
Withdrawn
The Wesley HospitalAuchenflower, 4066, Australia
Active, not recruiting
Izmir Ekonomi Universitesi Medikal Point HastanesiIzmir, 35575, Turkey
Active, not recruiting
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza KorhazSzolnok, 5000, Hungary
Active, not recruiting
Scanmed SA ZOZ GastromedLublin, 20-582, Poland
Active, not recruiting
Hospital Lucus AugustíLugo, 27003, Spain
Active, not recruiting
Complejo Hospitalario de JaénJaén, 23007, Spain
Active, not recruiting
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Active, not recruiting
Hospital Universitario Puerta del MarCadiz, 11009, Spain
Withdrawn
Swietokrzyskie Centrum OnkologiiKielce, 25-734, Poland
Active, not recruiting
Hospital Central de AsturiasOviedo, 33011, Spain
Withdrawn
Royal Free HospitalLondon, NW3 2QG, United Kingdom
Active, not recruiting
I.C.O GironaGirona, 17007, Spain
Withdrawn
Universitätsmedizin Göttingen - Hämatologie und medizin. OnkologieGöttingen, D-37077, Germany
Completed
Gosford HospitalGosford, 2250, Australia
Withdrawn
Illawarra Shoalhaven Local Health DistrictWollongong, 2521, Australia

Primary Outcome

  • Overall survival (OS)
    date_rangeTime Frame:
    Up to five years

Secondary Outcome

  • Time to first symptomatic skeletal event (SSE)
    date_rangeTime Frame:
    Up to five years
  • 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.
    date_rangeTime Frame:
    Up to five years
  • 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.
    date_rangeTime Frame:
    Up to five years
  • Adverse events assessments using NCI CTCAE (v5.0)
    date_rangeTime Frame:
    After first administration of study intervention up to 30 days after the last dose of study intervention
  • Incidence of fractures
    date_rangeTime Frame:
    Up to five years
  • 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.
    date_rangeTime Frame:
    Up to five years

Trial design

A Phase 4, randomized, open-label, multicenter efficacy and safety study of standard dose of radium-223 dichloride vs. standard doses of novel anti-hormonal therapy (NAH) in patients with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2