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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

Sponsor
Bayer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04597125
Collaborator
(none)
696
Enrollment
155
Locations
2
Arms
41.5
Anticipated Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
  • Drug: NAH therapy
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
696 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 9, 2020
Anticipated Primary Completion Date :
Apr 25, 2024
Anticipated Study Completion Date :
Apr 25, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

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

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Participants will receive Radium-223 (BAY88-8223) every 4 weeks for a total of 6 administrations via intravenous (IV) injection
Active Comparator: Arm B

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)

Drug: NAH therapy
Participants will receive continuous NAH (either Abiraterone acetate plus prednisone/prednisolone [AAP] or enzalutamide) by mouth (per os) daily
Other Names:
  • Second novel anti-hormonal therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) [Up to five years]

    Secondary Outcome Measures

    1. Time to first symptomatic skeletal event (SSE) [Up to five years]

    2. Radiological Progression-free survival (rPFS) [Up to five years]

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

    3. Time to pain progression (BPI-SF) [Up to five years]

      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.

    4. Adverse events assessments using NCI CTCAE (v5.0) [After first administration of study intervention up to 30 days after the last dose of study intervention]

    5. Incidence of fractures [Up to five years]

    6. Time to deterioration of FACT-P total score [Up to five years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Specialist Services Medical Group Castle Hill New South Wales Australia 2154
    2 North West Cancer Centre North Tamworth New South Wales Australia 2340
    3 Prince of Wales Hospital NSW Randwick New South Wales Australia 2031
    4 Northern Cancer Institute St Leonards New South Wales Australia 2065
    5 Wollongong Private Hospital Wollongong New South Wales Australia 2500
    6 The Wesley Hospital Auchenflower Queensland Australia 4066
    7 Icon Cancer Care Brisbane Queensland Australia 4101
    8 Tasman Health Care Southport Queensland Australia 4215
    9 The Tweed Hospital Tugun Queensland Australia 4224
    10 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    11 Calvary North Adelaide Hospital North Adelaide South Australia Australia 5006
    12 Nepean Hospital Penrith Australia 2757
    13 Kepler Universitätsklinikum Campus III Linz Oberösterreich Austria 4020
    14 Klinik Ottakring - Wilhelminenspital Wien Austria 1160
    15 Fakultni nemocnice u sv. Anny Brno Czechia 656 91
    16 Nemocnice Chomutov, o.z. Chomutov Czechia 430 12
    17 Krajska Nemocnice Liberec a.s. Liberec Czechia 460 63
    18 Fakultni Nemocnice Olomouc Olomouc Czechia 775 20
    19 Urocentrum Praha, s.r.o. Praha 2 Czechia 120 00
    20 Vseobecna fakultni nemocnice v Praze Praha 2 Czechia 128 08
    21 Fakultni Thomayerova Nemocnice Praha 4 Czechia 140 59
    22 Fakultní nemocnice Bulovka Praha 8 Czechia 180 81
    23 Docrates Klinikka Helsinki Finland 00180
    24 Kuopion yliopistollinen sairaala Kuopio Finland 70210
    25 Oulun yliopistollinen sairaala Oulu Finland 90029
    26 Seinäjoen keskussairaala Seinäjoki Finland FIN 60220
    27 Tampereen yliopistollinen sairaala, keskussairaala Tampere Finland 33520
    28 Hopital Jean Minjoz Besancon France 25030
    29 Institut Bergonié - Unicancer Nouvelle Aquitaine Bordeaux Cedex France 33076
    30 Hôpital Saint André - Bordeaux Bordeaux France 33000
    31 Hôpital Morvan - Brest Brest France 29285
    32 Centre de Lutte Contre le Cancer François Baclesse Caen Cedex 5 France 14076
    33 Hôpital Henri Mondor Creteil France 94010
    34 Centre Georges Francois Leclerc Dijon Dijon France 21079
    35 Centre Hospitalier Universitaire - Grenoble Grenoble France 38043
    36 Clinique Sainte Marguerite - Hyères Hyeres France 83400
    37 Centre Oscar Lambret - Lille Lille Cedex France 59020
    38 Centre Léon Bérard Lyon Cedex France 69008
    39 Institut Paoli-Calmettes - Marseille Marseille France 13273
    40 Institut du Cancer de Montpellier - Val d'Aurelle Montpellier Cedex France 34298
    41 Centre Antoine Lacassagne Nice Cedex 2 France 06102
    42 Institut de Cancérologie Jean Godinot REIMS cedex France 51726
    43 Centre Eugène Marquis - Rennes Cedex Rennes France 35042
    44 CHU STRASBOURG - Hôpital de Hautepierre Strasbourg France 67098
    45 Institut Claudius Regaud - iUCT Oncopole Toulouse Cedex 9 France 31059
    46 Hôpital Bretonneau Tours France 37044
    47 Institut de Cancérologie de Lorraine - Alexis Vautrin Vandoeuvre Les Nancy France 54000
    48 Institut Gustave Roussy Villejuif Cedex France 94805
    49 Universitätsklinikum Münster (UKM) Münster Nordrhein-Westfalen Germany 48149
    50 Universitätsmedizin der Johannes Gutenberg Universität Mainz Mainz Rheinland-Pfalz Germany 55131
    51 Universitätsklinikum Carl Gustav Carus Dresden Dresden Sachsen Germany 01307
    52 Urologische Gemeinschaftspraxis Bremen Bremen Germany 28277
    53 Universitätsmedizin Göttingen Göttingen Germany D-37077
    54 Pamela Youde Nethersole Eastern Hospital Chai Wan Hong Kong
    55 Hong Kong Sanatorium & Hospital Happy Valley Hong Kong
    56 Hong Kong Integrated Oncology Centre Hong Kong Hong Kong
    57 Queen Mary Hospital Hong Kong Hong Kong
    58 Tuen Mun Hospital Hong Kong Hong Kong
    59 Prince of Wales Hospital Hong Kong Shatin Hong Kong
    60 MH Egeszsegugyi Kozpont Budapest Hungary 1062
    61 Semmelweis University Budapest Hungary 1086
    62 Debreceni Egyetem Klinikai Kozpont Debrecen Hungary 4032
    63 Tolna Megyei Balassa Janos Korhaz Szekszard Hungary 7100
    64 Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Szolnok Hungary H-5004
    65 Rambam Health Corporation Haifa Israel 3109601
    66 Lady Davis Carmel Medical Center Haifa Israel 3436212
    67 Edith Wolfson Medical Center Holon Israel 5822012
    68 Hadassah Hebrew University Hospital Ein Kerem Jerusalem Israel 9112001
    69 Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva Israel 4941492
    70 Tel-Aviv Sourasky Medical Center Tel Aviv Israel 6423906
    71 A.O.R.N. Antonio Cardarelli Napoli Campania Italy 80131
    72 A.O.U. di Ferrara Ferrara Emilia-Romagna Italy 44124
    73 A.O.U. di Modena - Policlinico Modena Emilia-Romagna Italy 41124
    74 A.O.U. di Parma Parma Emilia-Romagna Italy 43126
    75 AUSL-IRCCS di Reggio Emilia Reggio Emilia Emilia-Romagna Italy 42123
    76 IRCCS Centro di Riferimento Oncologico (CRO) Pordenone Friuli-Venezia Giulia Italy 33081
    77 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Lazio Italy 00168
    78 E.O. Ospedali Galliera Genova Liguria Italy 16128
    79 IRCCS Istituto Europeo di Oncologia s.r.l. (IEO) Milano Lombardia Italy 20141
    80 A.O. Nazionale SS Antonio e Biagio e Cesare Arrigo Alessandria Piemonte Italy 15121
    81 A.O.U. Pisana Pisa Toscana Italy 56126
    82 APSS Trento Trento Trentino-Alto Adige Italy 38100
    83 A.O. Santa Maria Terni Terni Umbria Italy 05100
    84 Istituto Oncologico Veneto IRCCS (IOV) Padova Veneto Italy 35128
    85 National Cancer Center Goyang-si Gyeonggido Korea, Republic of 10408
    86 Seoul National University Bundang Hospital Seongnam-si Gyeonggido Korea, Republic of 463-707
    87 Seoul National University Hospital Seoul Seoul Teugbyeolsi Korea, Republic of 03080
    88 Asan Medical Center Seoul Korea, Republic of 05505
    89 Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    90 The Hospital of Lithuanian University of Health SciencesLUHS Kaunas Lithuania LT-50009
    91 PI Klaipedos University Hospital Klaipeda Lithuania LT-92288
    92 National Cancer Institute Vilnius Lithuania LT-08660
    93 Vilnius University Hospital Santaros Klinikos Vilnius Lithuania LT-08661
    94 Centrum Onkologii im. Prof. Franciszka Lukaszczyka Bydgoszcz Poland 85-796
    95 Swietokrzyskie Centrum Onkologii Kielce Poland 25-734
    96 Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Koszalin Poland 75-851
    97 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Krakow Poland 31-115
    98 Scanmed SA ZOZ Gastromed Lublin Poland 20-582
    99 Szpital Grochowski im. dr.med. Rafala Masztaka Warszawa Poland 04-073
    100 Uniwersytecki Szpital Kliniczny UM we Wroclawiu Wroclaw Poland 50-556
    101 Chelyabinsk Regional Oncology Dispensary Chelyabinsk Russian Federation 454087
    102 Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS Moscow Russian Federation 115552
    103 National Medical Research Radiology Center Obninsk Russian Federation 249036
    104 Clinical Oncological Dispensary of Omsk Region Omsk Russian Federation 644013
    105 Samara Regional Clinical Oncology Dispensary Samara Russian Federation 443031
    106 Tomsk National Research Medical Center of RAS Tomsk Russian Federation 634009
    107 Singapore General Hospital Singapore Singapore 169608
    108 National Cancer Center Singapore Singapore Singapore 169610
    109 Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela A Coruña Spain 15706
    110 Hospital Universitario Puerta del Mar Cádiz Andalucía Spain 11009
    111 Hospital Central de Asturias Oviedo Asturias Spain 33011
    112 Hospital Universitari Germans Trias i Pujol Badalona (Barcelona) Barcelona Spain 08916
    113 Hospital Universitari Son Espases Palma de Mallorca Illes Baleares Spain 07120
    114 Hospital Universitario Clinica Puerta de Hierro Majadahonda Madrid Spain 28222
    115 Centro Oncológico de Galicia A Coruña Spain 15009
    116 Hospital de la Santa Creu i de Sant Pau Barcelona Spain 08025
    117 Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona Spain 08035
    118 Consorcio Hospitalario Provincial de Castellón Castellón Spain 12002
    119 I.C.O Girona Girona Spain 17007
    120 Complejo Hospitalario de Jaén Jaén Spain 23007
    121 Hopsital Lucus Agustí Lugo Spain 27003
    122 Hospital Ramón y Cajal Madrid Spain 28034
    123 Hospital Universitario 12 de Octubre Madrid Spain 28041
    124 Hospital Virgen de la Victoria Málaga Spain 29010
    125 Instituto Valenciano de Oncología Valencia Spain 46009
    126 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
    127 Taichung Veterans General Hospital Taichung Taiwan 40705
    128 National Cheng Kung University Hospital Tainan Taiwan 704
    129 Taipei Veterans General Hospital Taipei Taiwan 11217
    130 Chang Gung Memorial Hospital at Linkou Taoyuan Taiwan 33305
    131 Baskent Universitesi Seyhan Hastanesi Adana Turkey 1250
    132 Hacettepe Universitesi Tip Fakultesi Ankara Turkey 06100
    133 Ankara Yildirim Beyazit Universitesi Tip Fakültesi Ankara Turkey 6050
    134 Ankara Universitesi Tip Fakultesi Hastanesi Ankara Turkey
    135 Trakya Univ. Tip Fak. Edirne Turkey 22030
    136 Gaziantep Universitesi Tip Fakultesi Gaziantep Turkey 27010
    137 Koc Universitesi Tip Fakultesi Istanbul Turkey 34010
    138 Istanbul Universitesi Istanbul Tip Fakultesi Istanbul Turkey 34093
    139 Istanbul Egitim ve Arastirma Hastanesi Istanbul Turkey 34098
    140 Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi Istanbul Turkey 34098
    141 TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has Istanbul Turkey 34772
    142 Medipol Universitesi Tip Fakultesi Istanbul Turkey 34810
    143 Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi Istanbul Turkey 34899
    144 Izmir Tepecik Egitim ve Arastirma Hastanesi Izmir Turkey 35020
    145 Ege Universitesi Tip Fakultesi Izmir Turkey 35100
    146 Dokuz Eylul Universitesi Tip Fakultesi Izmir Turkey 35330
    147 Medical Park Izmir Hastanesi Izmir Turkey 35575
    148 Erciyes Universitesi Tip Fakultesi Kayseri Turkey 38039
    149 Mersin Universitesi Tip Fakultesi Mersin Turkey 33070
    150 Ondokuz Mayis Uni Tip Fakultesi Samsun Turkey 55139
    151 Royal Berkshire Hospital Reading Berkshire United Kingdom RG1 5AN
    152 Royal Preston Hospital Preston Lancashire United Kingdom PR2 4HT
    153 Royal Surrey County Hospital Guildford Surrey United Kingdom GU2 7XX
    154 Beatson West of Scotland Cancer Centre Glasgow United Kingdom G12 0YN
    155 Royal Free Hospital London United Kingdom NW3 2QG

    Sponsors and Collaborators

    • Bayer

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bayer
    ClinicalTrials.gov Identifier:
    NCT04597125
    Other Study ID Numbers:
    • 20510
    • 2019-000476-42
    First Posted:
    Oct 22, 2020
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Radium Ra 223 dichloride

    Study Results

    No Results Posted as of Aug 22, 2022