Spots Global Cancer Trial Database for 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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Trial Identification
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 ID: NCT04597125
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Specialist Services Medical Group, Castle Hill, New South Wales, Australia
Gosford Hospital, Gosford, New South Wales, Australia
North West Cancer Centre, North Tamworth, New South Wales, Australia
Prince of Wales Hospital NSW, Randwick, New South Wales, Australia
Northern Cancer Institute, St Leonards, New South Wales, Australia
Illawarra Shoalhaven Local Health District, Wollongong, New South Wales, Australia
Illawarra Shoalhaven Local Health District, Wollongong, New South Wales, Australia
The Wesley Hospital, Auchenflower, Queensland, Australia
Icon Cancer Care, Brisbane, Queensland, Australia
Tasman Health Care, Southport, Queensland, Australia
The Tweed Hospital, Tugun, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Calvary North Adelaide Hospital, North Adelaide, South Australia, Australia
Nepean Hospital, Penrith, , Australia
Kepler UniversitÀtsklinikum Campus III, Linz, Oberösterreich, Austria
Klinik Ottakring - Wilhelminenspital, Wien, , Austria
Fakultni nemocnice u sv. Anny, Brno, , Czechia
Nemocnice Chomutov, o.z., Chomutov, , Czechia
Krajska Nemocnice Liberec, Liberec, , Czechia
Fakultni Nemocnice Olomouc, Olomouc, , Czechia
Fakultni Thomayerova Nemocnice, Prague, , Czechia
Urocentrum Praha, s.r.o., Praha 2, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
FakultnĂ nemocnice Bulovka, Praha 8, , Czechia
Docrates Klinikka, Helsinki, , Finland
Kuopion yliopistollinen sairaala, Kuopio, , Finland
Oulun yliopistollinen sairaala, Oulu, , Finland
SeinÀjoen keskussairaala, SeinÀjoki, , Finland
Tampereen yliopistollinen sairaala, keskussairaala, Tampere, , Finland
Hopital Jean Minjoz, Besancon, , France
HÎpital Saint André - Bordeaux, Bordeaux, , France
Institut Bergonié - Unicancer Nouvelle Aquitaine, Bordeaux, , France
HĂŽpital Morvan - Brest, Brest, , France
Centre de Lutte Contre le Cancer François Baclesse, Caen Cedex 5, , France
HĂŽpital Henri Mondor, Creteil, , France
Centre Georges Francois Leclerc Dijon, Dijon, , France
Centre Hospitalier Universitaire - Grenoble, Grenoble, , France
Clinique Sainte Marguerite - HyĂšres, Hyeres, , France
Centre Oscar Lambret - Lille, Lille Cedex, , France
Centre LĂ©on BĂ©rard, Lyon, , France
Institut Paoli-Calmettes - Marseille, Marseille, , France
Institut du Cancer de Montpellier - Val d'Aurelle, Montpellier Cedex, , France
Centre Antoine Lacassagne, Nice Cedex 2, , France
Institut de Cancérologie Jean Godinot, Reims, , France
Centre EugĂšne Marquis - Rennes Cedex, Rennes, , France
CHU STRASBOURG - HĂŽpital de Hautepierre, Strasbourg, , France
Institut Claudius Regaud - iUCT Oncopole, Toulouse Cedex 9, , France
HĂŽpital Bretonneau, Tours, , France
Institut de Cancérologie de Lorraine - Alexis Vautrin, Vandoeuvre-les-Nancy, , France
Institut Gustave Roussy - DĂ©partement de MĂ©decine Oncologique, Villejuif Cedex, , France
UniversitĂ€tsklinikum MĂŒnster (UKM), MĂŒnster, Nordrhein-Westfalen, Germany
UniversitÀtsmedizin der Johannes Gutenberg UniversitÀt Mainz, Mainz, Rheinland-Pfalz, Germany
UniversitÀtsklinikum Carl Gustav Carus Dresden, Dresden, Sachsen, Germany
Urologische Gemeinschaftspraxis Bremen, Bremen, , Germany
UniversitÀtsmedizin Göttingen - HÀmatologie und medizin. Onkologie, Göttingen, , Germany
Hong Kong Integrated Oncology Centre (HKIOC), Central, , Hong Kong
Pamela Youde Nethersole Eastern Hospital, Chai Wan, , Hong Kong
Hong Kong Sanatorium & Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Prince of Wales Hospital, Shatin, , Hong Kong
Tuen Mun Hospital, TBC, , Hong Kong
Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, , Hungary
Semmelweis University, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, , Hungary
Tolna Varmegyei Balassa Janos Korhaz, Szekszard, , Hungary
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz, Szolnok, , Hungary
Rambam Health Corporation, Haifa, , Israel
Lady Davis Carmel Medical Center, Haifa, , Israel
Edith Wolfson Medical Center, Holon, , Israel
Hadassah Hebrew University Hospital Ein Kerem, Jerusalem, , Israel
Clalit Health Services Rabin Medical Center-Beilinson Campus, Petah Tikva, , Israel
Tel-Aviv Sourasky Medical Center, Tel Aviv, , Israel
A.O.R.N. Antonio Cardarelli, Napoli, Campania, Italy
A.O.U. di Ferrara, Ferrara, Emilia-Romagna, Italy
A.O.U. di Modena - Policlinico, Modena, Emilia-Romagna, Italy
A.O.U. di Parma, Parma, Emilia-Romagna, Italy
AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Emilia-Romagna, Italy
IRCCS Centro di Riferimento Oncologico (CRO), Pordenone, Friuli-Venezia Giulia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Lazio, Italy
E.O. Ospedali Galliera, Genova, Liguria, Italy
IRCCS Istituto Europeo di Oncologia s.r.l. (IEO), Milano, Lombardia, Italy
A.O. Nazionale SS Antonio e Biagio e Cesare Arrigo - Oncologia, Alessandria, Piemonte, Italy
A.O.U. Pisana, Pisa, Toscana, Italy
APSS Trento, Trento, Trentino-Alto Adige, Italy
A.O. Santa Maria Terni, Terni, Umbria, Italy
Istituto Oncologico Veneto IRCCS (IOV), Padova, Veneto, Italy
National Cancer Center, Goyang-si, Gyeonggido, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggido, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
The Hospital of Lithuanian University of Health SciencesLUHS, Kaunas, , Lithuania
PI Klaipedos University Hospital, Klaipeda, , Lithuania
National Cancer Institute, Vilnius, , Lithuania
Vilnius University Hospital Santaros Klinikos, Vilnius, , Lithuania
Centrum Onkologii im. Prof. Franciszka Lukaszczyka, Bydgoszcz, , Poland
Swietokrzyskie Centrum Onkologii, Kielce, , Poland
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie - Oddzial Dzienny Chemioterapii, Koszalin, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Krakow, , Poland
Scanmed SA ZOZ Gastromed, Lublin, , Poland
Szpital Grochowski im. dr.med. Rafala Masztaka, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny UM we Wroclawiu, Wroclaw, , Poland
Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, , Russian Federation
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS, Moscow, , Russian Federation
National Medical Research Radiology Center, Obninsk, , Russian Federation
Clinical Oncological Dispensary of Omsk Region, Omsk, , Russian Federation
Samara Regional Clinical Oncology Dispensary, Samara, , Russian Federation
Tomsk National Research Medical Center of RAS, Tomsk, , Russian Federation
Singapore General Hospital, Singapore, , Singapore
National Cancer Center Singapore, Singapore, , Singapore
Hospital ClĂnico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain
Hospital Universitario Puerta del Mar, Cadiz, AndalucĂa, Spain
Hospital Central de Asturias, Oviedo, Asturias, Spain
Hospital Universitari Germans Trias i Pujol, Badalona (Barcelona), Barcelona, Spain
Hospital Universitari Son Espases, Palma de Mallorca, Illes Baleares, Spain
Hospital Universitario Clinica Puerta de Hierro, Majadahonda, Madrid, Spain
Centro Oncológico de Galicia, A Coruña, , Spain
Hospital de la Santa Creu i Sant Pau | Gynecology Department, Barcelona, , Spain
Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona, , Spain
Consorcio Hospitalario Provincial de CastellĂłn, CastellĂłn, , Spain
I.C.O Girona, Girona, , Spain
Complejo Hospitalario de Jaén, Jaén, , Spain
Hospital Lucus AugustĂ, Lugo, , Spain
Hospital Universitario Ramon y Cajal | Departamento de Medicina Interna, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Virgen de la Victoria | Cardiology Department, MĂĄlaga, , Spain
Instituto Valenciano de OncologĂa, Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Kaohsiung, Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital at Linkou, Taoyuan, , Taiwan
Baskent Universitesi Seyhan Hastanesi, Adana, , Turkey
Hacettepe Universitesi Tip Fakultesi, Ankara, , Turkey
Ankara Yildirim Beyazit Universitesi Tip FakĂŒltesi, Ankara, , Turkey
Ankara Universitesi Tip Fakultesi Hastanesi, Ankara, , Turkey
Trakya Univ. Tip Fak., Edirne, , Turkey
Gaziantep Universitesi Tip Fakultesi, Gaziantep, , Turkey
Koc Universitesi Tip Fakultesi - Radyoloji, Istanbul, , Turkey
Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul, , Turkey
Istanbul Egitim ve Arastirma Hastanesi, Istanbul, , Turkey
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi, Istanbul, , Turkey
TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has, Istanbul, , Turkey
Medipol Universitesi Tip Fakultesi, Istanbul, , Turkey
Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi, Istanbul, , Turkey
Izmir Tepecik Egitim ve Arastirma Hastanesi, Izmir, , Turkey
Ege Universitesi Tip Fakultesi, Izmir, , Turkey
Dokuz Eylul Universitesi Tip Fakultesi, Izmir, , Turkey
Izmir Ekonomi Universitesi Medikal Point Hastanesi, Izmir, , Turkey
Erciyes Universitesi Tip Fakultesi, Kayseri, , Turkey
Mersin Universitesi Tip Fakultesi, Mersin, , Turkey
Ondokuz Mayis Uni Tip Fakultesi, Samsun, , Turkey
Royal Berkshire Hospital, Reading, Berkshire, United Kingdom
Royal Preston Hospital, Preston, Lancashire, United Kingdom
Royal Surrey County Hospital, Guildford, Surrey, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Royal Free Hospital, London, , United Kingdom
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