Trial Condition(s):
metastatic castrate resistant prostate cancer (mCRPC)
Investigation of Radium-223 dichloride (Xofigo), a treatment that gives off radiation that helps kill cancer cells, compared to a treatment that inactivates hormones (new antihormonal therapy, NAH) in patients with prostate cancer that has spread to the bone getting worse on or after earlier NAH
Bayer Identifier:
20510
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
2023-505830-89-00
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations The Hospital of Lithuanian University of Health SciencesLUHS Kaunas, Lithuania, LT-50009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PI Klaipedos University Hospital Klaipeda, Lithuania, LT-92288 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Institute Vilnius, Lithuania, LT-08660 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vilnius University Hospital Santaros Klinikos Vilnius, Lithuania, LT-08661 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Thomayerova Nemocnice Prague, Czech Republic, 140 59 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Chomutov, o.z. Chomutov, Czech Republic, 430 12 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultní nemocnice Bulovka Praha 8, Czech Republic, 180 81 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice u sv. Anny Brno, Czech Republic, 656 91 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urocentrum Praha, s.r.o. Praha 2, Czech Republic, 120 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vseobecna fakultni nemocnice v Praze Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krajska Nemocnice Liberec Liberec, Czech Republic, 460 63 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lady Davis Carmel Medical Center Haifa, Israel, 3436212 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tel-Aviv Sourasky Medical Center Tel Aviv, Israel, 6423906 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Gustave Roussy - Département de Médecine Oncologique VILLEJUIF CEDEX, France, 94805 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dokuz Eylul Universitesi Tip Fakultesi Izmir, Turkey, 35100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medipol Universitesi Tip Fakultesi Istanbul, Turkey, 34810 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Izmir Tepecik Egitim ve Arastirma Hastanesi Izmir, Turkey, 35180 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gaziantep Universitesi Tip Fakultesi Gaziantep, Turkey, 27070 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Istanbul Tip Fakultesi Istanbul, Turkey, 34093 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Erciyes Universitesi Tip Fakultesi Kayseri, Turkey, 38039 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hacettepe Universitesi Tip Fakultesi Ankara, Turkey, 6100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ege Universitesi Tip Fakultesi Izmir, Turkey, 35100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Baskent Universitesi Seyhan Hastanesi Adana, Turkey, 1250 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ondokuz Mayis Uni Tip Fakultesi Samsun, Turkey, 55139 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Marmara University Medical Faculty | Pediatric Nephrology Istanbul, Turkey, 34899 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ankara Universitesi Tip Fakultesi Hastanesi Ankara, Turkey, 6100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ankara Yildirim Beyazit Universitesi Tip Fakültesi ANKARA, Turkey, 6050 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has ISTANBUL, Turkey, 34722 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Trakya Univ. Tip Fak. Edirne, Turkey, 22030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Consorcio Hospitalario Provincial de Castellón Castellón, Spain, 12002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari Son Espases Palma De Mallorca, Spain, 7120 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Valenciano de Oncología Valencia, Spain, 46009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Clinica Puerta de Hierro Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de la Santa Creu i Sant Pau | Gynecology Department Barcelona, Spain, 8041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Oncológico de Galicia A Coruña, Spain, 15009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, Unmapped, 05505 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul St. Mary's Hospital Seoul, Unmapped, 6591 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Goyang-si, Unmapped, 10408 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Bundang Hospital Seongnam-si, Unmapped, 13620 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, Unmapped, 3080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Mary Hospital Hong Kong, Hong Kong, China, MISSING | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prince of Wales Hospital Hong Kong, Hong Kong, China, MISSING | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pamela Youde Nethersole Eastern Hospital Chai Wan, Hong Kong, China, 0 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tuen Mun Hospital TBC, Hong Kong, China, TBC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hong Kong Integrated Oncology Centre (HKIOC) Central, Hong Kong, China, 0 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 33305 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cheng Kung University Hospital Tainan, Taiwan, China, 704 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, Taiwan, China, 807377 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi Istanbul, Turkey, 34098 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations APSS Trento Trento, Italy, 38100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations E.O. Ospedali Galliera Genova, Italy, 16128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Modena - Policlinico Modena, Italy, 41100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro di Riferimento Oncologico di Aviano Pordenone, Italy, 33081 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Oncologico Veneto_Padova - UOC Oncologia 1 Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica Parma, Italy, 43126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Europeo di Oncologia s.r.l Milano, Italy, 20141 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. Nazionale SS Antonio e Biagio e Cesare Arrigo - Oncologia Alessandria, Italy, 15121 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Ferrara Ferrara, Italy, 44124 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Servizio di Radioterapia Oncologica Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beatson West of Scotland Cancer Centre Glasgow, United Kingdom, G12 0YN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Berkshire NHS Foundation Trust¦Royal Berkshire Hospital - Oncology Reading, United Kingdom, RG1 5AN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mersin Universitesi Tip Fakultesi Mersin, Turkey, 33079 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinik Ottakring - Wilhelminenspital Wien, Austria, 1160 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kepler Universitätsklinikum Campus III Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Egitim ve Arastirma Hastanesi Istanbul, Turkey, 34098 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut de Cancérologie de Lorraine - Alexis Vautrin Vandoeuvre-les-Nancy, France, 54519 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Georges Francois Leclerc Dijon DIJON, France, 21079 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre de Lutte Contre le Cancer François Baclesse CAEN CEDEX 5, France, 14076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Antoine Lacassagne NICE CEDEX 2, France, 6189 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire - Grenoble grenoble, France, 38700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Eugène Marquis - Rennes Cedex RENNES CEDEX, France, 35062 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Henri Mondor Creteil, France, 94010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Morvan - Brest BREST, France, 29470 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU STRASBOURG - Hôpital de Hautepierre Strasbourg, France, 67200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Saint André - Bordeaux BORDEAUX, France, 33000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie - Oddzial Dzienny Chemioterapii Koszalin, Poland, 75-851 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Krakow, Poland, 31-115 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital Grochowski im. dr.med. Rafala Masztaka Warszawa, Poland, 04-073 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniwersytecki Szpital Kliniczny UM we Wroclawiu Wroclaw, Poland, 50-556 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tampereen yliopistollinen sairaala Tampere, Finland, 33520 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seinäjoen keskussairaala Seinäjoki, Finland, 60220 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Docrates Klinikka Helsinki, Finland, 00180 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oulun yliopistollinen sairaala Oulu, Finland, 90220 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Singapore General Hospital Singapore, Singapore, 169608 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Singapore Singapore, Singapore, 168583 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Semmelweis University Budapest, Hungary, 1083 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chelyabinsk Regional Oncology Dispensary Chelyabinsk, Russia, 454087 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Medical Research Radiology Center Obninsk, Russia, 249036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Icon Cancer Care Brisbane, Australia, 4101 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tasman Health Care Southport, Australia, 4215 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Specialist Services Medical Group Castle Hill, Australia, 2154 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nepean Hospital Kingswood, Australia, 2747 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prince of Wales Hospital NSW Sydney, Australia, 2031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations North West Cancer Centre North Tamworth, Australia, 2340 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Illawarra Shoalhaven Local Health District Wollongong, Australia, 2500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Tweed Hospital Tugun, Australia, 4224 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitaetsklinikum Muenster Münster, Germany, 48149 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsmedizin der Johannes Gutenberg Universität Mainz Mainz, Germany, 55101 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut de Cancérologie Jean Godinot Reims, France, 51726 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de la Victoria | Cardiology Department Malaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Paoli-Calmettes - Marseille MARSEILLE, France, 13273 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northern Cancer Institute St Leonards, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Izmir Ekonomi Universitesi Medikal Point Hastanesi Izmir, Turkey, 35575 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz Szolnok, Hungary, 5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Scanmed SA ZOZ Gastromed Lublin, Poland, 20-582 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Lucus Augustí Lugo, Spain, 27003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Complejo Hospitalario de Jaén Jaén, Spain, 23007 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Puerta del Mar Cadiz, Spain, 11009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Central de Asturias Oviedo, Spain, 33011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations I.C.O Girona Girona, Spain, 17007 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gosford Hospital Gosford, Australia, 2250 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A Phase 4, randomized, open-label, multicenter efficacy and safety study of standard dose of radium-223 dichloride vs. standard doses of novel anti-hormonal therapy (NAH) in patients with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Overall survival (OS)Timeframe: Up to five years
Secondary Outcome
- Time to first symptomatic skeletal event (SSE)Timeframe: 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.Timeframe: 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.Timeframe: Up to five years
- Adverse events assessments using NCI CTCAE (v5.0)Timeframe: After first administration of study intervention up to 30 days after the last dose of study intervention
- Incidence of fracturesTimeframe: 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.Timeframe: Up to five years
Additional Information
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