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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

Primary Purpose

Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Radium-223 dichloride (Xofigo, BAY88-8223)
NAH therapy
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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.

Sites / Locations

  • Specialist Services Medical GroupRecruiting
  • Gosford Hospital (GH) - Central Coast Cancer Centre
  • North West Cancer CentreRecruiting
  • Prince of Wales Hospital NSWRecruiting
  • Northern Cancer InstituteRecruiting
  • Wollongong Private HospitalRecruiting
  • Wollongong Hospital
  • The Wesley Hospital
  • Icon Cancer CareRecruiting
  • Tasman Health CareRecruiting
  • The Tweed HospitalRecruiting
  • Royal Adelaide HospitalRecruiting
  • Calvary North Adelaide Hospital
  • Nepean HospitalRecruiting
  • Kepler Universitätsklinikum Campus IIIRecruiting
  • Klinik Ottakring - WilhelminenspitalRecruiting
  • Fakultni nemocnice u sv. AnnyRecruiting
  • Nemocnice Chomutov, o.z.Recruiting
  • Krajska Nemocnice LiberecRecruiting
  • Fakultni Nemocnice Olomouc
  • Fakultni Thomayerova NemocniceRecruiting
  • Urocentrum Praha, s.r.o.Recruiting
  • Vseobecna fakultni nemocnice v PrazeRecruiting
  • Fakultní nemocnice BulovkaRecruiting
  • Docrates Klinikka
  • Kuopion yliopistollinen sairaala
  • Oulun yliopistollinen sairaalaRecruiting
  • Seinäjoen keskussairaalaRecruiting
  • Tampereen yliopistollinen sairaala, keskussairaalaRecruiting
  • Hopital Jean Minjoz
  • Hôpital Saint André - BordeauxRecruiting
  • Institut Bergonié - Unicancer Nouvelle Aquitaine
  • Hôpital Morvan - BrestRecruiting
  • Centre de Lutte Contre le Cancer François BaclesseRecruiting
  • Hôpital Henri MondorRecruiting
  • Centre Georges Francois Leclerc DijonRecruiting
  • Centre Hospitalier Universitaire - GrenobleRecruiting
  • Clinique Sainte Marguerite - Hyères
  • Centre Oscar Lambret - Lille
  • Centre Léon Bérard
  • Institut Paoli-Calmettes - MarseilleRecruiting
  • Institut du Cancer de Montpellier - Val d'Aurelle
  • Centre Antoine LacassagneRecruiting
  • Institut de Cancérologie Jean GodinotRecruiting
  • Centre Eugène Marquis - Rennes CedexRecruiting
  • CHU STRASBOURG - Hôpital de HautepierreRecruiting
  • Institut Claudius Regaud - iUCT Oncopole
  • Hôpital Bretonneau
  • Institut de Cancérologie de Lorraine - Alexis VautrinRecruiting
  • Institut Gustave Roussy - Département de Médecine OncologiqueRecruiting
  • Universitätsklinikum Münster (UKM)Recruiting
  • Universitätsmedizin der Johannes Gutenberg Universität MainzRecruiting
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Urologische Gemeinschaftspraxis Bremen
  • Universitätsmedizin Göttingen - Hämatologie und medizin. Onkologie
  • Pamela Youde Nethersole Eastern HospitalRecruiting
  • Hong Kong Sanatorium & Hospital
  • Hong Kong Integrated Oncology Centre
  • Queen Mary HospitalRecruiting
  • Tuen Mun HospitalRecruiting
  • Prince of Wales Hospital Hong KongRecruiting
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Semmelweis UniversityRecruiting
  • Debreceni Egyetem Klinikai Kozpont
  • Tolna Varmegyei Balassa Janos Korhaz
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza KorhazRecruiting
  • Rambam Health Corporation
  • Lady Davis Carmel Medical CenterRecruiting
  • Edith Wolfson Medical Center
  • Hadassah Hebrew University Hospital Ein Kerem
  • Clalit Health Services Rabin Medical Center-Beilinson Campus
  • Tel-Aviv Sourasky Medical CenterRecruiting
  • A.O.R.N. Antonio Cardarelli
  • A.O.U. di FerraraRecruiting
  • A.O.U. di Modena - PoliclinicoRecruiting
  • A.O.U. di ParmaRecruiting
  • AUSL-IRCCS di Reggio Emilia
  • IRCCS Centro di Riferimento Oncologico (CRO)Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
  • E.O. Ospedali GallieraRecruiting
  • IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)Recruiting
  • A.O. Nazionale SS Antonio e Biagio e Cesare Arrigo - OncologiaRecruiting
  • A.O.U. Pisana
  • APSS TrentoRecruiting
  • A.O. Santa Maria Terni
  • Istituto Oncologico Veneto IRCCS (IOV)Recruiting
  • National Cancer CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Seoul St. Mary's HospitalRecruiting
  • The Hospital of Lithuanian University of Health SciencesLUHSRecruiting
  • PI Klaipedos University HospitalRecruiting
  • National Cancer InstituteRecruiting
  • Vilnius University Hospital Santaros Klinikos
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka
  • Swietokrzyskie Centrum Onkologii
  • Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie - Oddzial Dzienny ChemioterapiiRecruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-CurieRecruiting
  • Scanmed SA ZOZ GastromedRecruiting
  • Szpital Grochowski im. dr.med. Rafala MasztakaRecruiting
  • Uniwersytecki Szpital Kliniczny UM we WroclawiuRecruiting
  • Chelyabinsk Regional Oncology Dispensary
  • Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
  • National Medical Research Radiology Center
  • Clinical Oncological Dispensary of Omsk Region
  • Samara Regional Clinical Oncology Dispensary
  • Tomsk National Research Medical Center of RAS
  • Singapore General HospitalRecruiting
  • National Cancer Center SingaporeRecruiting
  • Hospital Clínico Universitario de Santiago de CompostelaRecruiting
  • Hospital Universitario Puerta del MarRecruiting
  • Hospital Central de AsturiasRecruiting
  • Hospital Universitari Germans Trias i PujolRecruiting
  • Hospital Universitari Son EspasesRecruiting
  • Hospital Universitario Clinica Puerta de HierroRecruiting
  • Centro Oncológico de GaliciaRecruiting
  • Hospital de la Santa Creu i Sant Pau | Gynecology DepartmentRecruiting
  • Ciutat Sanitaria i Universitaria de la Vall d'HebronRecruiting
  • Consorcio Hospitalario Provincial de CastellónRecruiting
  • I.C.O GironaRecruiting
  • Complejo Hospitalario de JaénRecruiting
  • Hospital Lucus AugustíRecruiting
  • Hospital Ramón y Cajal
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario Virgen de la Victoria | Cardiology DepartmentRecruiting
  • Instituto Valenciano de OncologíaRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Chang Gung Memorial Hospital at LinkouRecruiting
  • Baskent Universitesi Seyhan HastanesiRecruiting
  • Hacettepe Universitesi Tip FakultesiRecruiting
  • Ankara Yildirim Beyazit Universitesi Tip FakültesiRecruiting
  • Ankara Universitesi Tip Fakultesi HastanesiRecruiting
  • Trakya Univ. Tip Fak.Recruiting
  • Gaziantep Universitesi Tip FakultesiRecruiting
  • Koc Universitesi Tip Fakultesi - Radyoloji
  • Istanbul Universitesi Istanbul Tip FakultesiRecruiting
  • Istanbul Egitim ve Arastirma HastanesiRecruiting
  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip FakultesiRecruiting
  • TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir HasRecruiting
  • Medipol Universitesi Tip FakultesiRecruiting
  • Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. HastanesiRecruiting
  • Izmir Tepecik Egitim ve Arastirma HastanesiRecruiting
  • Ege Universitesi Tip FakultesiRecruiting
  • Dokuz Eylul Universitesi Tip FakultesiRecruiting
  • Izmir Ekonomi Universitesi Medikal Point HastanesiRecruiting
  • Erciyes Universitesi Tip FakultesiRecruiting
  • Mersin Universitesi Tip FakultesiRecruiting
  • Ondokuz Mayis Uni Tip FakultesiRecruiting
  • Royal Berkshire HospitalRecruiting
  • Royal Preston Hospital
  • Royal Surrey County Hospital
  • Beatson West of Scotland Cancer Centre
  • Royal Free Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Participants with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH will be randomized to receive radium-223 dichloride

Participants with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH will be randomized to receive second novel anti-hormonal therapy (NAH)

Outcomes

Primary Outcome Measures

Overall survival (OS)

Secondary Outcome Measures

Time to first symptomatic skeletal event (SSE)
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.
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.
Adverse events assessments using NCI CTCAE (v5.0)
Incidence of fractures
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.

Full Information

First Posted
October 16, 2020
Last Updated
September 26, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04597125
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castrate Resistant Prostate Cancer (mCRPC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
696 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Participants with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH will be randomized to receive radium-223 dichloride
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Participants with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH will be randomized to receive second novel anti-hormonal therapy (NAH)
Intervention Type
Drug
Intervention Name(s)
Radium-223 dichloride (Xofigo, BAY88-8223)
Intervention Description
Participants will receive Radium-223 (BAY88-8223) every 4 weeks for a total of 6 administrations via intravenous (IV) injection
Intervention Type
Drug
Intervention Name(s)
NAH therapy
Other Intervention Name(s)
Second novel anti-hormonal therapy
Intervention Description
Participants will receive continuous NAH (either Abiraterone acetate plus prednisone/prednisolone [AAP] or enzalutamide) by mouth (per os) daily
Primary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
Up to five years
Secondary Outcome Measure Information:
Title
Time to first symptomatic skeletal event (SSE)
Time Frame
Up to five years
Title
Radiological Progression-free survival (rPFS)
Description
rPFS is defined as the time from the date of randomization to the date of confirmed radiological progression or death, whichever occurs first.
Time Frame
Up to five years
Title
Time to pain progression (BPI-SF)
Description
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.
Time Frame
Up to five years
Title
Adverse events assessments using NCI CTCAE (v5.0)
Time Frame
After first administration of study intervention up to 30 days after the last dose of study intervention
Title
Incidence of fractures
Time Frame
Up to five years
Title
Time to deterioration of FACT-P total score
Description
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.
Time Frame
Up to five years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bayer Clinical Trials Contact
Phone
(+)1-888-84 22937
Email
clinical-trials-contact@bayer.com
Facility Information:
Facility Name
Specialist Services Medical Group
City
Castle Hill
State/Province
New South Wales
ZIP/Postal Code
2154
Country
Australia
Individual Site Status
Recruiting
Facility Name
Gosford Hospital (GH) - Central Coast Cancer Centre
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
North West Cancer Centre
City
North Tamworth
State/Province
New South Wales
ZIP/Postal Code
2340
Country
Australia
Individual Site Status
Recruiting
Facility Name
Prince of Wales Hospital NSW
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Name
Northern Cancer Institute
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Wollongong Private Hospital
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Name
Wollongong Hospital
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2521
Country
Australia
Individual Site Status
Withdrawn
Facility Name
The Wesley Hospital
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Icon Cancer Care
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Tasman Health Care
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Tweed Hospital
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Calvary North Adelaide Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Nepean Hospital
City
Penrith
ZIP/Postal Code
2757
Country
Australia
Individual Site Status
Recruiting
Facility Name
Kepler Universitätsklinikum Campus III
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinik Ottakring - Wilhelminenspital
City
Wien
ZIP/Postal Code
1160
Country
Austria
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice u sv. Anny
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Nemocnice Chomutov, o.z.
City
Chomutov
ZIP/Postal Code
430 12
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Krajska Nemocnice Liberec
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni Nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Fakultni Thomayerova Nemocnice
City
Prague
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Urocentrum Praha, s.r.o.
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultní nemocnice Bulovka
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Docrates Klinikka
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Individual Site Status
Completed
Facility Name
Kuopion yliopistollinen sairaala
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Individual Site Status
Withdrawn
Facility Name
Oulun yliopistollinen sairaala
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Individual Site Status
Recruiting
Facility Name
Seinäjoen keskussairaala
City
Seinäjoki
ZIP/Postal Code
FIN 60220
Country
Finland
Individual Site Status
Recruiting
Facility Name
Tampereen yliopistollinen sairaala, keskussairaala
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Name
Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Withdrawn
Facility Name
Hôpital Saint André - Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Bergonié - Unicancer Nouvelle Aquitaine
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Withdrawn
Facility Name
Hôpital Morvan - Brest
City
Brest
ZIP/Postal Code
29285
Country
France
Individual Site Status
Recruiting
Facility Name
Centre de Lutte Contre le Cancer François Baclesse
City
Caen Cedex 5
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Georges Francois Leclerc Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire - Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
Clinique Sainte Marguerite - Hyères
City
Hyeres
ZIP/Postal Code
83400
Country
France
Individual Site Status
Withdrawn
Facility Name
Centre Oscar Lambret - Lille
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Individual Site Status
Withdrawn
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Withdrawn
Facility Name
Institut Paoli-Calmettes - Marseille
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Name
Institut du Cancer de Montpellier - Val d'Aurelle
City
Montpellier Cedex
ZIP/Postal Code
34298
Country
France
Individual Site Status
Withdrawn
Facility Name
Centre Antoine Lacassagne
City
Nice Cedex 2
ZIP/Postal Code
06102
Country
France
Individual Site Status
Recruiting
Facility Name
Institut de Cancérologie Jean Godinot
City
Reims
ZIP/Postal Code
51726
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Eugène Marquis - Rennes Cedex
City
Rennes
ZIP/Postal Code
35042
Country
France
Individual Site Status
Recruiting
Facility Name
CHU STRASBOURG - Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Claudius Regaud - iUCT Oncopole
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Withdrawn
Facility Name
Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Institut de Cancérologie de Lorraine - Alexis Vautrin
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy - Département de Médecine Oncologique
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster (UKM)
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin der Johannes Gutenberg Universität Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Urologische Gemeinschaftspraxis Bremen
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsmedizin Göttingen - Hämatologie und medizin. Onkologie
City
Göttingen
ZIP/Postal Code
D-37077
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Chai Wan
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Hong Kong Sanatorium & Hospital
City
Happy Valley
Country
Hong Kong
Individual Site Status
Withdrawn
Facility Name
Hong Kong Integrated Oncology Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Prince of Wales Hospital Hong Kong
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1086
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Tolna Varmegyei Balassa Janos Korhaz
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
City
Szolnok
ZIP/Postal Code
H-5004
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Hadassah Hebrew University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Clalit Health Services Rabin Medical Center-Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
A.O.R.N. Antonio Cardarelli
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O.U. di Ferrara
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U. di Modena - Policlinico
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U. di Parma
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Recruiting
Facility Name
AUSL-IRCCS di Reggio Emilia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Centro di Riferimento Oncologico (CRO)
City
Pordenone
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
E.O. Ospedali Galliera
City
Genova
State/Province
Liguria
ZIP/Postal Code
16128
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Nazionale SS Antonio e Biagio e Cesare Arrigo - Oncologia
City
Alessandria
State/Province
Piemonte
ZIP/Postal Code
15121
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U. Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Withdrawn
Facility Name
APSS Trento
City
Trento
State/Province
Trentino-Alto Adige
ZIP/Postal Code
38100
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Santa Maria Terni
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Istituto Oncologico Veneto IRCCS (IOV)
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggido
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggido
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Hospital of Lithuanian University of Health SciencesLUHS
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
PI Klaipedos University Hospital
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
National Cancer Institute
City
Vilnius
ZIP/Postal Code
LT-08660
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Individual Site Status
Completed
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Swietokrzyskie Centrum Onkologii
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie - Oddzial Dzienny Chemioterapii
City
Koszalin
ZIP/Postal Code
75-851
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Individual Site Status
Recruiting
Facility Name
Scanmed SA ZOZ Gastromed
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Grochowski im. dr.med. Rafala Masztaka
City
Warszawa
ZIP/Postal Code
04-073
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Name
Chelyabinsk Regional Oncology Dispensary
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
City
Moscow
ZIP/Postal Code
115552
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
National Medical Research Radiology Center
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Clinical Oncological Dispensary of Omsk Region
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Samara Regional Clinical Oncology Dispensary
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Tomsk National Research Medical Center of RAS
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Name
National Cancer Center Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta del Mar
City
Cádiz
State/Province
Andalucía
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona (Barcelona)
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Son Espases
City
Palma de Mallorca
State/Province
Illes Baleares
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Clinica Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro Oncológico de Galicia
City
A Coruña
ZIP/Postal Code
15009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau | Gynecology Department
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Consorcio Hospitalario Provincial de Castellón
City
Castellón
ZIP/Postal Code
12002
Country
Spain
Individual Site Status
Recruiting
Facility Name
I.C.O Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario de Jaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Lucus Augustí
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de la Victoria | Cardiology Department
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
State/Province
Kaohsiung
ZIP/Postal Code
807377
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital at Linkou
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Baskent Universitesi Seyhan Hastanesi
City
Adana
ZIP/Postal Code
1250
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Yildirim Beyazit Universitesi Tip Fakültesi
City
Ankara
ZIP/Postal Code
6050
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Universitesi Tip Fakultesi Hastanesi
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya Univ. Tip Fak.
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gaziantep Universitesi Tip Fakultesi
City
Gaziantep
ZIP/Postal Code
27010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Koc Universitesi Tip Fakultesi - Radyoloji
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul Egitim ve Arastirma Hastanesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has
City
Istanbul
ZIP/Postal Code
34772
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medipol Universitesi Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34810
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Izmir Tepecik Egitim ve Arastirma Hastanesi
City
Izmir
ZIP/Postal Code
35020
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Izmir Ekonomi Universitesi Medikal Point Hastanesi
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Erciyes Universitesi Tip Fakultesi
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Mersin Universitesi Tip Fakultesi
City
Mersin
ZIP/Postal Code
33070
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz Mayis Uni Tip Fakultesi
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Royal Berkshire Hospital
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Preston Hospital
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 4HT
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Royal Surrey County Hospital
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Learn more about this trial

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

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