do_not_disturb_altRecruitment Complete
metastatic castrate resistant prostate cancer (mCRPC)
Bayer Identifier:
20510
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
2023-505830-89-00
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.
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
MaleAge
18 - N/ATrial summary
Enrollment Goal
696Trial Dates
November 2020 - October 2026Phase
Phase 4Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | The Hospital of Lithuanian University of Health SciencesLUHS | Kaunas, LT-50009, Lithuania |
Completed | PI Klaipedos University Hospital | Klaipeda, LT-92288, Lithuania |
Completed | National Cancer Institute | Vilnius, LT-08660, Lithuania |
Completed | Vilnius University Hospital Santaros Klinikos | Vilnius, LT-08661, Lithuania |
Withdrawn | Fakultní Nemocnice Olomouc | Olomouc, 77900, Czech Republic |
Active, not recruiting | Fakultni Thomayerova Nemocnice | Prague, 140 59, Czech Republic |
Completed | Nemocnice Chomutov, o.z. | Chomutov, 430 12, Czech Republic |
Completed | Fakultní nemocnice Bulovka | Praha 8, 180 81, Czech Republic |
Active, not recruiting | Fakultni nemocnice u sv. Anny | Brno, 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 Praze | Praha 2, 12808, Czech Republic |
Active, not recruiting | Krajska Nemocnice Liberec | Liberec, 460 63, Czech Republic |
Withdrawn | Edith Wolfson Medical Center | Internal Medicine Department | Holon, 5822012, Israel |
Withdrawn | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem, 9112001, Israel |
Withdrawn | Rambam Health Corporation | Haifa, 3109601, Israel |
Active, not recruiting | Lady Davis Carmel Medical Center | Haifa, 3436212, Israel |
Active, not recruiting | Tel-Aviv Sourasky Medical Center | Tel Aviv, 6423906, Israel |
Active, not recruiting | Gustave Roussy - Departement Oncologie-Radiotherapie | VILLEJUIF CEDEX, 94805, France |
Completed | Dokuz Eylul Universitesi Tip Fakultesi | Izmir, 35100, Turkey |
Withdrawn | Koc Universitesi Tip Fakultesi - Radyoloji | Istanbul, 34010, Turkey |
Active, not recruiting | Medipol Universitesi Tip Fakultesi | Istanbul, 34810, Turkey |
Active, not recruiting | Izmir Tepecik Egitim ve Arastirma Hastanesi | Izmir, 35180, Turkey |
Active, not recruiting | Gaziantep Universitesi Tip Fakultesi | Gaziantep, 27070, Turkey |
Completed | Istanbul Universitesi Istanbul Tip Fakultesi | Istanbul, 34093, Turkey |
Active, not recruiting | Erciyes Universitesi Tip Fakultesi | Kayseri, 38039, Turkey |
Completed | Hacettepe Universitesi Tip Fakultesi | Ankara, 6100, Turkey |
Active, not recruiting | Ege Universitesi Tip Fakultesi | Izmir, 35100, Turkey |
Active, not recruiting | Baskent Universitesi Seyhan Hastanesi | Adana, 1250, Turkey |
Completed | Ondokuz Mayis Uni Tip Fakultesi | Samsun, 55139, Turkey |
Active, not recruiting | Marmara University Medical Faculty | Pediatric Nephrology | Istanbul, 34899, Turkey |
Active, not recruiting | Ankara Universitesi Tip Fakultesi Hastanesi | Ankara, 6100, Turkey |
Completed | Ankara Yildirim Beyazit Universitesi Tip Fakültesi | ANKARA, 6050, Turkey |
Active, not recruiting | TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has | ISTANBUL, 34722, Turkey |
Active, not recruiting | Trakya Univ. Tip Fak. | Edirne, 22030, Turkey |
Active, not recruiting | Consorcio Hospitalario Provincial de Castellón | Castellón, 12002, Spain |
Active, not recruiting | Hospital Universitari Son Espases | Palma De Mallorca, 7120, Spain |
Active, not recruiting | Hospital Universitario 12 de Octubre | Madrid, 28041, Spain |
Withdrawn | Hospital Universitario Ramon y Cajal | Departamento de Medicina Interna | Madrid, 28034, Spain |
Active, not recruiting | Instituto Valenciano de Oncología | Valencia, 46009, Spain |
Completed | Hospital Universitari Germans Trias i Pujol | Badalona, 08916, Spain |
Active, not recruiting | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Active, not recruiting | Hospital Universitario Clinica Puerta de Hierro | Majadahonda, 28222, Spain |
Active, not recruiting | Hospital de la Santa Creu i Sant Pau | Gynecology Department | Barcelona, 8041, Spain |
Active, not recruiting | Centro Oncológico de Galicia | A Coruña, 15009, Spain |
Active, not recruiting | Asan Medical Center | Seoul, 05505, Korea,_republic_of |
Completed | Seoul St. Mary's Hospital | Seoul, 6591, Korea,_republic_of |
Active, not recruiting | National Cancer Center | Goyang-si, 10408, Korea,_republic_of |
Active, not recruiting | Seoul National University Bundang Hospital | Seongnam-si, 13620, Korea,_republic_of |
Completed | Seoul National University Hospital | Seoul, 3080, Korea,_republic_of |
Active, not recruiting | Queen Mary Hospital | Hong Kong, MISSING, Hong Kong |
Active, not recruiting | Prince of Wales Hospital | Hong Kong, MISSING, Hong Kong |
Active, not recruiting | Pamela Youde Nethersole Eastern Hospital | Chai Wan, Hong Kong |
Active, not recruiting | Tuen Mun Hospital | TBC, TBC, Hong Kong |
Not yet recruiting | Hong Kong Integrated Oncology Centre (HKIOC) | Central, Hong Kong |
Withdrawn | Hong Kong Sanatorium & Hospital | Hong Kong, N/A, Hong Kong |
Completed | Taipei Veterans General Hospital | Taipei, 11217, Taiwan |
Active, not recruiting | Chang Gung Memorial Hospital at Linkou | Taoyuan, 33305, Taiwan |
Active, not recruiting | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Active, not recruiting | National Cheng Kung University Hospital | Tainan, 704, Taiwan |
Active, not recruiting | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City, 807377, Taiwan |
Withdrawn | Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department | Petah Tikva, 4941492, Israel |
Completed | Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi | Istanbul, 34098, Turkey |
Active, not recruiting | Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia Medica | Trento, 38122, Italy |
Active, not recruiting | Ente Ospedaliero Ospedali Galliera Di Genova - Oncologia Medica | Genova, 16128, Italy |
Active, not recruiting | Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia | Modena, 41124, Italy |
Withdrawn | Azienda Ospedaliera S Maria Di Terni | Terni, 6129, Italy |
Active, not recruiting | Centro di Riferimento Oncologico di Aviano | Pordenone, 33081, Italy |
Withdrawn | A.O.U. Pisana | Pisa, 56126, Italy |
Active, not recruiting | Istituto Oncologico Veneto_Padova - UOC Oncologia 1 | Padova, 35128, Italy |
Active, not recruiting | Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica | Parma, 43126, Italy |
Completed | Istituto Europeo di Oncologia s.r.l | Milano, 20141, Italy |
Active, not recruiting | Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria_Presidio Civile - Oncologia | Alessandria, 15121, Italy |
Active, not recruiting | University Hospital Of Ferrara - Oncologia Clinica | Ferrara, 44124, Italy |
Withdrawn | Azienda USL IRCCS di Reggio Emilia | Reggio Emilia, 42123, Italy |
Withdrawn | Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli | Napoli, 80131, Italy |
Completed | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Servizio di Radioterapia Oncologica | Roma, 00168, Italy |
Completed | Beatson West of Scotland Cancer Centre | Glasgow, G12 0YN, United Kingdom |
Withdrawn | Royal Surrey County Hospital | Guildford, GU2 7XX, United Kingdom |
Withdrawn | Royal Preston Hospital | Preston, PR2 4HT, United Kingdom |
Active, not recruiting | Royal Berkshire NHS Foundation Trust¦Royal Berkshire Hospital - Oncology | Reading, RG1 5AN, United Kingdom |
Completed | Mersin Universitesi Tip Fakultesi | Mersin, 33079, Turkey |
Active, not recruiting | Klinik Ottakring - Wilhelminenspital | Wien, 1160, Austria |
Completed | Kepler Universitätsklinikum Campus III | Linz, 4020, Austria |
Completed | Istanbul Egitim ve Arastirma Hastanesi | Istanbul, 34098, Turkey |
Withdrawn | Clinique Sainte Marguerite - Hyères | HYERES, 83400, France |
Completed | Institut de Cancérologie de Lorraine - Alexis Vautrin | Vandoeuvre-les-Nancy, 54519, France |
Completed | Centre Georges Francois Leclerc Dijon | DIJON, 21079, France |
Withdrawn | Centre Oscar Lambret - Lille | LILLE CEDEX, 59020, France |
Withdrawn | Institut Bergonié - Unicancer Nouvelle Aquitaine | Bordeaux, 33076, France |
Completed | Centre de Lutte Contre le Cancer François Baclesse | CAEN CEDEX 5, 14076, France |
Withdrawn | Hopital Jean Minjoz | BESANCON, 25030, France |
Active, not recruiting | Centre Antoine Lacassagne | NICE CEDEX 2, 6189, France |
Active, not recruiting | Centre Hospitalier Universitaire - Grenoble | grenoble, 38700, France |
Active, not recruiting | Centre Eugène Marquis - Rennes Cedex | RENNES CEDEX, 35062, France |
Active, not recruiting | Hôpital Henri Mondor | Creteil, 94010, France |
Active, not recruiting | Hôpital Morvan - Brest | BREST, 29470, France |
Withdrawn | Centre Léon Bérard | lyon, 69008, France |
Completed | CHU Strasbourg - Hopital Hautepierre | Strasbourg, 67200, France |
Active, not recruiting | Hôpital Saint André - Bordeaux | BORDEAUX, 33000, France |
Withdrawn | Hopital Bretonneau | Tours, 37044, France |
Withdrawn | Institut du Cancer de Montpellier - Val d'Aurelle | MONTPELLIER CEDEX, 34298, France |
Withdrawn | Centrum Onkologii im. Prof. Franciszka Lukaszczyka | Bydgoszcz, 85-796, Poland |
Active, not recruiting | Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie - Oddzial Dzienny Chemioterapii | Koszalin, 75-851, Poland |
Completed | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie | Krakow, 31-115, Poland |
Active, not recruiting | Szpital Grochowski im. dr.med. Rafala Masztaka | Warszawa, 04-073, Poland |
Active, not recruiting | Uniwersytecki Szpital Kliniczny UM we Wroclawiu | Wroclaw, 50-556, Poland |
Active, not recruiting | Tampereen yliopistollinen sairaala | Tampere, 33520, Finland |
Withdrawn | Kuopion yliopistollinen sairaala | Kuopio, 70210, Finland |
Completed | Seinäjoen keskussairaala | Seinäjoki, 60220, Finland |
Completed | Docrates Klinikka | Helsinki, 00180, Finland |
Completed | Oulun yliopistollinen sairaala | Oulu, 90220, Finland |
Active, not recruiting | Singapore General Hospital | Singapore, 169608, Singapore |
Active, not recruiting | National Cancer Center Singapore | Singapore, 168583, Singapore |
Completed | Semmelweis University | Budapest, 1083, Hungary |
Withdrawn | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Withdrawn | Tolna Varmegyei Balassa Janos Korhaz | Szekszard, 7100, Hungary |
Withdrawn | Magyar Honvedseg Egeszsegugyi Kozpont | Budapest, 1062, Hungary |
Withdrawn | Clinical Oncological Dispensary of Omsk Region | Omsk, 644013, Russian Federation |
Completed | Chelyabinsk Regional Oncology Dispensary | Chelyabinsk, 454087, Russia |
Completed | National Medical Research Radiology Center | Obninsk, 249036, Russia |
Withdrawn | Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS | Moscow, 115552, Russian Federation |
Withdrawn | Samara Regional Clinical Oncology Dispensary | Samara, 443031, Russian Federation |
Withdrawn | Tomsk National Research Medical Center of RAS | Tomsk, 634009, Russian Federation |
Active, not recruiting | Icon Cancer Care | Brisbane, 4101, Australia |
Active, not recruiting | Tasman Health Care | Southport, 4215, Australia |
Active, not recruiting | Specialist Services Medical Group | Castle Hill, 2154, Australia |
Active, not recruiting | Nepean Hospital | Kingswood, 2747, Australia |
Active, not recruiting | Prince of Wales Hospital NSW | Sydney, 2031, Australia |
Active, not recruiting | North West Cancer Centre | North Tamworth, 2340, Australia |
Active, not recruiting | Royal Adelaide Hospital | Adelaide, 5000, Australia |
Withdrawn | Calvary North Adelaide Hospital | North Adelaide, 5006, Australia |
Active, not recruiting | Illawarra Shoalhaven Local Health District | Wollongong, 2500, Australia |
Completed | The Tweed Hospital | Tugun, 4224, Australia |
Active, not recruiting | Universitaetsklinikum Muenster | Münster, 48149, Germany |
Withdrawn | Urologische Gemeinschaftspraxis Bremen | Bremen, 28277, Germany |
Withdrawn | Universitätsklinikum Carl Gustav Carus Dresden | Dresden, 01307, Germany |
Completed | Universitätsmedizin der Johannes Gutenberg Universität Mainz | Mainz, 55101, Germany |
Active, not recruiting | Institut de Cancerologie Jean Godinot | Reims, 51726, France |
Active, not recruiting | Hospital Universitario Virgen de la Victoria | Cardiology Department | Malaga, 29010, Spain |
Withdrawn | Institut Claudius Regaud - iUCT Oncopole | TOULOUSE CEDEX 9, 31059, France |
Active, not recruiting | Institut Paoli-Calmettes - Marseille | MARSEILLE, 13273, France |
Completed | Northern Cancer Institute | St Leonards, 2065, Australia |
Withdrawn | The Wesley Hospital | Auchenflower, 4066, Australia |
Active, not recruiting | Izmir Ekonomi Universitesi Medikal Point Hastanesi | Izmir, 35575, Turkey |
Active, not recruiting | Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz | Szolnok, 5000, Hungary |
Active, not recruiting | Scanmed SA ZOZ Gastromed | Lublin, 20-582, Poland |
Active, not recruiting | Hospital Lucus Augustí | Lugo, 27003, Spain |
Active, not recruiting | Complejo Hospitalario de Jaén | Jaén, 23007, Spain |
Active, not recruiting | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela, 15706, Spain |
Active, not recruiting | Hospital Universitario Puerta del Mar | Cadiz, 11009, Spain |
Withdrawn | Swietokrzyskie Centrum Onkologii | Kielce, 25-734, Poland |
Active, not recruiting | Hospital Central de Asturias | Oviedo, 33011, Spain |
Withdrawn | Royal Free Hospital | London, NW3 2QG, United Kingdom |
Active, not recruiting | I.C.O Girona | Girona, 17007, Spain |
Withdrawn | Universitätsmedizin Göttingen - Hämatologie und medizin. Onkologie | Göttingen, D-37077, Germany |
Completed | Gosford Hospital | Gosford, 2250, Australia |
Withdrawn | Illawarra Shoalhaven Local Health District | Wollongong, 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 fracturesdate_rangeTime Frame:Up to five years
- Time to deterioration of FACT-P total scoreThe 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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2