Clinical trial • Phase IV • Oncology
Radium Ra 223 dichloride for Metastatic castration-resistant prostate cancer
Phase IV trial of Radium Ra 223 dichloride for Metastatic castration-resistant prostate cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic castration-resistant prostate cancer
- Trial Stage
- Phase IV
- Drug Modality
- Radiopharmaceutical|Small molecule
Key dates
- Initial CTIS Submission Date
- 15-11-2023
- First CTIS Authorization Date
- 08-02-2024
Trial design
Randomised, open-label, comparator arm (arm b): second novel anti-hormonal therapy (nah) – examples listed in product/comparator information include zytiga 500 mg film-coated tablets (abiraterone acetate) – max daily dose shown 1000 mg (oral, daily) and xtandi - 40 mg soft capsules (enzalutamide) – max daily dose shown 160 mg (oral, daily). concomitant corticosteroid options listed include deltacortene 5 mg (prednisone) and prednisolone 5mg tablets (prednisolone) (oral, up to 10 mg daily as documented).-controlled Phase IV trial in Austria, Czechia, Finland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Comparator arm (Arm B): Second novel anti-hormonal therapy (NAH) – examples listed in product/comparator information include ZYTIGA 500 mg film-coated tablets (abiraterone acetate) – max daily dose shown 1000 mg (oral, daily) and Xtandi - 40 mg soft capsules (enzalutamide) – max daily dose shown 160 mg (oral, daily). Concomitant corticosteroid options listed include DELTACORTENE 5 mg (prednisone) and Prednisolone 5mg Tablets (prednisolone) (oral, up to 10 mg daily as documented).
- Target Sample Size
- 292
Eligibility
Recruits 292 No vulnerable populations selected. Participants must be ≥18 years and "Capable of giving signed informed consent"; signed informed consent (ICF) is required. Subject information and consent documents (including parent/expecting-parents ICFs for male participants where applicable) are provided in multiple languages per country..
- Vulnerable Population
- No vulnerable populations selected. Participants must be ≥18 years and "Capable of giving signed informed consent"; signed informed consent (ICF) is required. Subject information and consent documents (including parent/expecting-parents ICFs for male participants where applicable) are provided in multiple languages per country.
Inclusion criteria
- {"criterion_text":"- Participant must be ≥18 years of age inclusive, at the time of signing the informed consent. The lower limit may be higher if legally required in the participating country.\n- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n- Participants who have histologically confirmed adenocarcinoma of the prostate.\n- 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.\n- One prior taxane treatment regimen (at least 2 cycles) for metastatic prostate cancer (mHSPC and mCRPC) or refusal or ineligibility of such a regimen.\n- 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.\n- 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.\n- 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.\n- 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. Skin cancer or low-grade superficial bladder cancer)\n- 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. Magnetic resonance imaging (MRI). Participants with history of spinal cord compression should have completely recovered.\n- Male. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants who have partners of childbearing potential (or whose partner is pregnant at study start) must use a condom during intercourse or sexual activity while receiving treatment and for 6 months following completion of treatment with radium-223 dichloride, 13 weeks after the last administration of abiraterone and 3 months after the last administration of enzalutamide. The contraception measures must be discussed with the participant. For a non-pregnant partner of childbearing potential, additional contraception recommendations should also be considered. Suitable contraception could be, for example, the use of an oral contraceptive by the partner. Note: Conservation of sperm: There are no human data on the effect of radium-223 dichloride on fertility; however, based on studies in animals, there is a potential risk that radiation from radium-223 dichloride could cause adverse effects on fertility. Participants should seek advice on conservation of sperm prior to treatment. b. Female participants: not applicable\n- Able to swallow abiraterone and prednisone / prednisolone or enzalutamide as whole tablets/capsules.\n- Laboratory requirements: a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L b. Platelet count ≥ 100 x 10^9/L c. Hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L; 5.6 mmol/L) d. Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (except for participants with documented Gilbert's disease) e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN f. 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 g. International normalized ratio (INR) of prothrombin time (PT; PTINR) 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) h. Serum albumin > 30 g/L I. Serum potassium ≥ 3.5 mmol/L\n- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.\n- Life expectancy ≥ 6 months."}
Exclusion criteria
- {"criterion_text":"- Active infection or other medical condition that would make prednisone / prednisolone (corticosteroid) use contraindicated.\n- Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone / prednisolone equivalent daily for more than 2 months.\n- Pathological finding consistent with tumors with predominant neuroendocrine features or small cell carcinoma of the prostate (ie. tumors documented as having a small cell carcinoma histology and those having predominant neuroendocrine features [if mixed histology]).\n- History of pituitary or adrenal dysfunction.\n- Any other serious illness or medical condition such as, but not limited to: a. Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 Grade 2. b. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe orunstable angina, or New York Heart Association (NYHA) Class II to IV heart disease or cardiac ejection fraction measurement of <50% at baseline. c. Current clinical evidence of any uncontrolled cardiac arrhythmia. d. Crohn's disease or ulcerative colitis. e. Bone marrow dysplasia. f. Moderate and severe hepatic impairment (Child-Pugh Classes B and C). g. Unmanageable fecal incontinence.\n- Hypersensitivity to the active substances or to any excipients of radium-223 dichloride, or abiraterone acetate or enzalutamide.\n- Prior therapeutic systemic radiation with any radiopharmaceutical medication for the treatment of prostate cancer, including but o tlimited 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.\n- 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.\n- Blood transfusion or erythropoietin stimulating agents 4 weeks prior to Screening and during the whole Screening period before randomization.\n- 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.\n- 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 antihypertensive treatment.\n- Active or symptomatic viral hepatitis.\n- Any condition, which in the opinion of the investigator would preclude participation in this trial (eg, history of seizure).\n- Prior administration of an investigational therapeutic for CRPC.\n- Previous (within the last 4 weeks of randomization) or concurrent participation in any interventional clinical study with investigational study drug administration.\n- History of osteoporotic fracture.\n- History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations.\n- History of or known brain metastasis.\n- Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.\n- Other malignancy treated within the last 3 years (except nonmelanoma skin cancer or low-grade superficial bladder cancer)\n- 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."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"Main objective: To assess the overall survival of radium-223 dichloride compared to second NAH (as stated in the trial objective)."}
Secondary endpoints
- {"endpoint_text":"- Time to first symptomatic skeletal event (SSE)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Radiological Progression-free survival (rPFS)","definition_or_measurement_approach":"Radiological progression-free survival as stated (rPFS)."}
- {"endpoint_text":"- Time to pain progression (BPI-SF)","definition_or_measurement_approach":"Measured using the Brief Pain Inventory-Short Form (BPI-SF)."}
- {"endpoint_text":"- Adverse events assessments using NCI CTCAE (V5.0)","definition_or_measurement_approach":"Adverse events assessed and graded using NCI CTCAE version 5.0."}
- {"endpoint_text":"- Incidence of fractures","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to deterioration of FACT-P total score","definition_or_measurement_approach":"Measured using the FACT-P instrument (time to deterioration of FACT-P total score)."}
Recruitment
- Planned Sample Size
- 292
- Recruitment Window Months
- 40
- Consent Approach
- Signed informed consent (ICF) is required from each participant; participants must be capable of giving signed informed consent. Consent documents and country-specific ICFs/addenda are provided (documents available in multiple languages such as English, French, Spanish, Hungarian, Italian as indicated in public documents). There are also specific parent/expecting-parents ICFs for male participants where applicable (documents listed per country). No assent process is indicated (participants are adults ≥18).
Geography
- Total Number Of Sites
- 63
- Total Number Of Participants
- 514
Austria
- Earliest CTIS Part Ii Submission Date
- 05-12-2023
- Latest Decision Or Authorization Date
- 12-02-2024
- Processing Time Days
- 69
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Clinic for Urology and Andrology
- Principal Investigator Name
- Steffen Krause
- Principal Investigator Email
- steffen.krause@kepleruniklinikum.at
- Contact Person Name
- Steffen Krause
- Contact Person Email
- steffen.krause@kepleruniklinikum.at
- Site Name
- Stadt Wien Wiener Gesundheitsverbund
- Department Name
- Medical Department
- Principal Investigator Name
- Ercan Müldür
- Principal Investigator Email
- ercan.muelduer@wienkav.at
- Contact Person Name
- Ercan Müldür
- Contact Person Email
- ercan.muelduer@wienkav.at
Czechia
- Earliest CTIS Part Ii Submission Date
- 05-12-2023
- Latest Decision Or Authorization Date
- 08-02-2024
- Processing Time Days
- 65
- Number Of Sites
- 8
- Number Of Participants
- 40
Sites
- Site Name
- University Hospital Olomouc
- Department Name
- Oncology department
- Principal Investigator Name
- Bohuslav Melichar
- Principal Investigator Email
- bohuslav.melichar@fnol.cz
- Contact Person Name
- Bohuslav Melichar
- Contact Person Email
- bohuslav.melichar@fnol.cz
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- Oncology-surgery department
- Principal Investigator Name
- Jana Katolicka
- Principal Investigator Email
- jana.katolicka@fnusa.cz
- Contact Person Name
- Jana Katolicka
- Contact Person Email
- jana.katolicka@fnusa.cz
- Site Name
- Fakultni Nemocnice Bulovka
- Department Name
- Oncology department
- Principal Investigator Name
- Petra Holeckova
- Principal Investigator Email
- petra.holeckova@bulovka.cz
- Contact Person Name
- Petra Holeckova
- Contact Person Email
- petra.holeckova@bulovka.cz
- Site Name
- Krajska nemocnice Liberec a.s.
- Department Name
- Urology
- Principal Investigator Name
- Vladimir Samal
- Principal Investigator Email
- vladimir.samal@nemlib.cz
- Contact Person Name
- Vladimir Samal
- Contact Person Email
- vladimir.samal@nemlib.cz
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Oncology department
- Principal Investigator Name
- Tomas Buchler
- Principal Investigator Email
- tomas.buchler@ftn.cz
- Contact Person Name
- Tomas Buchler
- Contact Person Email
- tomas.buchler@ftn.cz
- Site Name
- Krajska zdravotni a.s.
- Department Name
- Oncology department
- Principal Investigator Name
- Martina Chodacka
- Principal Investigator Email
- martina.chodacka@kzcr.eu
- Contact Person Name
- Martina Chodacka
- Contact Person Email
- martina.chodacka@kzcr.eu
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Clinic of Oncolgy
- Principal Investigator Name
- Martin Mateju
- Principal Investigator Email
- marti.mateju@vfn.cz
- Contact Person Name
- Martin Mateju
- Contact Person Email
- marti.mateju@vfn.cz
- Site Name
- Urocentrum Praha s.r.o.
- Department Name
- Oncology
- Principal Investigator Name
- Michaela Matouskova
- Principal Investigator Email
- matouskova@urocentrum.cz
- Contact Person Name
- Michaela Matouskova
- Contact Person Email
- matouskova@urocentrum.cz
Finland
- Earliest CTIS Part Ii Submission Date
- 05-12-2023
- Latest Decision Or Authorization Date
- 08-02-2024
- Processing Time Days
- 65
- Number Of Sites
- 3
- Number Of Participants
- 25
Sites
- Site Name
- Oulu University Hospital
- Department Name
- Dept. of Urology
- Principal Investigator Name
- Hanna Ronkainen
- Principal Investigator Email
- hanna.ronkainen@ppshp.fi
- Contact Person Name
- Hanna Ronkainen
- Contact Person Email
- hanna.ronkainen@ppshp.fi
- Site Name
- Tampere University Hospital
- Department Name
- Dep. of Urology
- Principal Investigator Name
- Teemu Murtola
- Principal Investigator Email
- hanna.ronkainen@ppshp.fi
- Contact Person Name
- Teemu Murtola
- Contact Person Email
- hanna.ronkainen@ppshp.fi
- Site Name
- Etelae-Pohjanmaan hyvinvointialue
- Department Name
- Dept. of Urology
- Principal Investigator Name
- Timo Martilla
- Principal Investigator Email
- timo.marttila@hyvaep.fi
- Contact Person Name
- Timo Martilla
- Contact Person Email
- timo.marttila@hyvaep.fi
Germany
- Earliest CTIS Part Ii Submission Date
- 05-12-2023
- Latest Decision Or Authorization Date
- 09-02-2024
- Processing Time Days
- 66
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Klinik -und Poliklinik für Urologie und Kinderurologie
- Principal Investigator Name
- Maximilan Brandt
- Principal Investigator Email
- maximilian.brandt@unimedizin-mainz.de
- Contact Person Name
- Maximilan Brandt
- Contact Person Email
- maximilian.brandt@unimedizin-mainz.de
- Site Name
- Westfaelische Wilhelms-Universitaet Muenster
- Department Name
- Klinik für Urologie
- Principal Investigator Name
- Martin Bögemann
- Principal Investigator Email
- martin.boegemann@ukmuenster.de
- Contact Person Name
- Martin Bögemann
- Contact Person Email
- martin.boegemann@ukmuenster.de
Lithuania
- Earliest CTIS Part Ii Submission Date
- 05-12-2023
- Latest Decision Or Authorization Date
- 14-02-2024
- Processing Time Days
- 71
- Number Of Sites
- 3
- Number Of Participants
- 35
Sites
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- Urology
- Principal Investigator Name
- Kestutis Vaiciunas
- Principal Investigator Email
- kvaic@yahoo.co.uk
- Contact Person Name
- Kestutis Vaiciunas
- Contact Person Email
- kvaic@yahoo.co.uk
- Site Name
- Klaipedos universiteto ligonine VšĮ
- Department Name
- Urology
- Principal Investigator Name
- Raimundas Venckus
- Principal Investigator Email
- raveuro@gmail.com
- Contact Person Name
- Raimundas Venckus
- Contact Person Email
- raveuro@gmail.com
- Site Name
- Nacionalinis vezio institutas
- Department Name
- Oncology-Urology
- Principal Investigator Name
- Albertas Ulys
- Principal Investigator Email
- albertasulys@gmail.com
- Contact Person Name
- Albertas Ulys
- Contact Person Email
- albertasulys@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 27-02-2024
- Latest Decision Or Authorization Date
- 07-03-2024
- Processing Time Days
- 9
- Number Of Sites
- 6
- Number Of Participants
- 90
Sites
- Site Name
- Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
- Department Name
- Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. Oddział Chemioterapii
- Principal Investigator Name
- Iwona Skoneczna
- Principal Investigator Email
- skoneczna@grochowski.waw.pl
- Contact Person Name
- Iwona Skoneczna
- Contact Person Email
- skoneczna@grochowski.waw.pl
- Site Name
- Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
- Department Name
- Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie Oddział Dzienny Chemioterapii
- Principal Investigator Name
- Mariusz Kwiatkowski
- Principal Investigator Email
- mariusz.kwiatkowski@swk.med.pl
- Contact Person Name
- Mariusz Kwiatkowski
- Contact Person Email
- mariusz.kwiatkowski@swk.med.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Uniwerytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego
- Principal Investigator Name
- Teresa Zarzycka
- Principal Investigator Email
- zarzyckat@gmail.com
- Contact Person Name
- Teresa Zarzycka
- Contact Person Email
- zarzyckat@gmail.com
- Site Name
- Onko-Centrum Sp. z o.o.
- Department Name
- Onko-Centrum Sp z o.o.
- Principal Investigator Name
- Pawel Iberszer
- Principal Investigator Email
- piberszer@gmail.com
- Contact Person Name
- Pawel Iberszer
- Contact Person Email
- piberszer@gmail.com
- Site Name
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
- Department Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Świętokrzyskie Centrum Onkologii, Klinika Onkologii
- Principal Investigator Name
- Dariusz Kucharczyk
- Principal Investigator Email
- darekku@me.com
- Contact Person Name
- Dariusz Kucharczyk
- Contact Person Email
- darekku@me.com
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Narodowy Instytut Onkologii im. Marii Skłodowskiej – Curie, Państwowy Instytut Badawczy Oddział w Kr
- Principal Investigator Name
- Marek Ziobro
- Principal Investigator Email
- mz5@wp.pl
- Contact Person Name
- Marek Ziobro
- Contact Person Email
- mz5@wp.pl
Italy
- Earliest CTIS Part Ii Submission Date
- 05-12-2023
- Latest Decision Or Authorization Date
- 12-02-2024
- Processing Time Days
- 69
- Number Of Sites
- 9
- Number Of Participants
- 40
Sites
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Department Name
- Medicina Generale e Specialistica - UOC Oncologia Medica
- Principal Investigator Name
- Donatello Gasparro
- Principal Investigator Email
- gasparrodonatello@gmail.com
- Contact Person Name
- Donatello Gasparro
- Contact Person Email
- gasparrodonatello@gmail.com
- Site Name
- University Hospital Of Ferrara
- Department Name
- Uo Oncologia
- Principal Investigator Name
- Massimo GUIDOBONI
- Principal Investigator Email
- massimo.guidoboni@unife.it
- Contact Person Name
- Massimo GUIDOBONI
- Contact Person Email
- massimo.guidoboni@unife.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- Dipartimento di Oncologia, Ematologia e Radioterapia
- Principal Investigator Name
- Roberto Sabbatini
- Principal Investigator Email
- roberto.sabbatini@unimore.it
- Contact Person Name
- Roberto Sabbatini
- Contact Person Email
- roberto.sabbatini@unimore.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Dipartimento Radioterapia
- Principal Investigator Name
- Maria Antonietta GAMBACORTA
- Principal Investigator Email
- mariaantoniettagambacorta@policlinicogemelli.it
- Contact Person Name
- Maria Antonietta GAMBACORTA
- Contact Person Email
- mariaantoniettagambacorta@policlinicogemelli.it
- Site Name
- Ente Ospedaliero Ospedali Galliera Di Genova
- Department Name
- Oncologia medica
- Principal Investigator Name
- Monica Boitano
- Principal Investigator Email
- monica.boitano@galliera.it
- Contact Person Name
- Monica Boitano
- Contact Person Email
- monica.boitano@galliera.it
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- Oncologia medica
- Principal Investigator Name
- Lucia Frantino
- Principal Investigator Email
- lfratino@cro.it
- Contact Person Name
- Lucia Frantino
- Contact Person Email
- lfratino@cro.it
- Site Name
- Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
- Department Name
- S.C. Oncologia
- Principal Investigator Name
- Pamela Guglielmini
- Principal Investigator Email
- pfguglielmini@ospedale.al.it
- Contact Person Name
- Pamela Guglielmini
- Contact Person Email
- pfguglielmini@ospedale.al.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncologia
- Principal Investigator Name
- Marco Maruzzo
- Principal Investigator Email
- marco.maruzzo@iov.veneto
- Contact Person Name
- Marco Maruzzo
- Contact Person Email
- marco.maruzzo@iov.veneto
- Site Name
- Azienda Provinciale Per I Servizi Sanitari
- Department Name
- UO di Oncologia Medica
- Principal Investigator Name
- Orazio Caffo
- Principal Investigator Email
- orazio.caffo@apss.tn.it
- Contact Person Name
- Orazio Caffo
- Contact Person Email
- orazio.caffo@apss.tn.it
France
- Earliest CTIS Part Ii Submission Date
- 16-01-2024
- Latest Decision Or Authorization Date
- 12-02-2024
- Processing Time Days
- 27
- Number Of Sites
- 13
- Number Of Participants
- 107
Sites
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Oncology
- Principal Investigator Name
- Sylvain LADOIRE
- Principal Investigator Email
- sladoire@cgfl.fr
- Contact Person Name
- Sylvain LADOIRE
- Contact Person Email
- sladoire@cgfl.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Benjamin AUBERGER
- Principal Investigator Email
- benjamin.auberger@chu-brest.fr
- Contact Person Name
- Benjamin AUBERGER
- Contact Person Email
- benjamin.auberger@chu-brest.fr
- Site Name
- Institut De Cancerologie Strasbourg Europe
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Philippe BARTHELEMY
- Principal Investigator Email
- p.barthelemy@icans.eu
- Contact Person Name
- Philippe BARTHELEMY
- Contact Person Email
- p.barthelemy@icans.eu
- Site Name
- Institut Paoli-Calmettes
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Gwenaëlle GRAVIS-MESCAM
- Principal Investigator Email
- gravisg@ipc.unicancer.fr
- Contact Person Name
- Gwenaëlle GRAVIS-MESCAM
- Contact Person Email
- gravisg@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Médecine nucléaire
- Principal Investigator Name
- Loïc DJAILEB
- Principal Investigator Email
- ndeleiris@chu-grenoble.fr
- Contact Person Name
- Loïc DJAILEB
- Contact Person Email
- ndeleiris@chu-grenoble.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Delphine BORCHIELLINI
- Principal Investigator Email
- delphine.borchiellini@nice.unicancer.fr
- Contact Person Name
- Delphine BORCHIELLINI
- Contact Person Email
- delphine.borchiellini@nice.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncology
- Principal Investigator Name
- Karim FIZAZI
- Principal Investigator Email
- karim.fizazi@igr.fr
- Contact Person Name
- Karim FIZAZI
- Contact Person Email
- karim.fizazi@igr.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Marine GROSS-GOUPIL
- Principal Investigator Email
- marine.gross-goupil@chu-bordeaux.fr
- Contact Person Name
- Marine GROSS-GOUPIL
- Contact Person Email
- marine.gross-goupil@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Charlotte FENIOUX
- Principal Investigator Email
- charlotte.fenioux@aphp.fr
- Contact Person Name
- Charlotte FENIOUX
- Contact Person Email
- charlotte.fenioux@aphp.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Brigitte LAGUERRE
- Principal Investigator Email
- b.laguerre@rennes.unicancer.fr
- Contact Person Name
- Brigitte LAGUERRE
- Contact Person Email
- b.laguerre@rennes.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Jean-Christophe EYMARD
- Principal Investigator Email
- jc.eymard@reims.unicancer.fr
- Contact Person Name
- Jean-Christophe EYMARD
- Contact Person Email
- jc.eymard@reims.unicancer.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Florence JOLY
- Principal Investigator Email
- f.joly@baclesse.fr
- Contact Person Name
- Florence JOLY
- Contact Person Email
- f.joly@baclesse.fr
- Site Name
- Institut De Cancerologie De Lorraine
- Department Name
- Oncology
- Principal Investigator Name
- Lionnel GEOFFROIS
- Principal Investigator Email
- l.geoffrois@nancy.unicancer.fr
- Contact Person Name
- Lionnel GEOFFROIS
- Contact Person Email
- l.geoffrois@nancy.unicancer.fr
Hungary
- Earliest CTIS Part Ii Submission Date
- 16-01-2024
- Latest Decision Or Authorization Date
- 08-02-2024
- Processing Time Days
- 23
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
- Department Name
- Oncology
- Principal Investigator Name
- Hajnalka Németh
- Principal Investigator Email
- nemethhajnalka@hotmail.com
- Contact Person Name
- Hajnalka Németh
- Contact Person Email
- nemethhajnalka@hotmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 05-12-2023
- Latest Decision Or Authorization Date
- 08-02-2024
- Processing Time Days
- 65
- Number Of Sites
- 16
- Number Of Participants
- 135
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Principal Investigator Name
- Jose Pablo Maroto Rey
- Principal Investigator Email
- Jmaroto@santpau.cat
- Contact Person Name
- Jose Pablo Maroto Rey
- Contact Person Email
- Jmaroto@santpau.cat
- Site Name
- University Hospital Son Espases
- Department Name
- Oncology
- Principal Investigator Name
- Aitor Azkarate Martinez
- Principal Investigator Email
- aitor.azkarate@ssib.es
- Contact Person Name
- Aitor Azkarate Martinez
- Contact Person Email
- aitor.azkarate@ssib.es
- Site Name
- Consorcio Hospitalario Provincial De Castellon
- Department Name
- Oncology
- Principal Investigator Name
- Alfredo Sanchez Hernandez
- Principal Investigator Email
- asanchezh@seom.org
- Contact Person Name
- Alfredo Sanchez Hernandez
- Contact Person Email
- asanchezh@seom.org
- Site Name
- Hospital Universitario Puerta Del Mar
- Department Name
- Oncology
- Principal Investigator Name
- Maria Jose Ledo Cepero
- Principal Investigator Email
- uroled@gmail.com
- Contact Person Name
- Maria Jose Ledo Cepero
- Contact Person Email
- uroled@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncology
- Principal Investigator Name
- Ana Maria Carballo Castro
- Principal Investigator Email
- ana.maria.carballo.castro@sergas.es
- Contact Person Name
- Ana Maria Carballo Castro
- Contact Person Email
- ana.maria.carballo.castro@sergas.es
- Site Name
- Hospital Universitario De Jaen
- Department Name
- Oncology
- Principal Investigator Name
- Juan Moreno Jiménez
- Principal Investigator Email
- juanmoreno35@hotmail.com
- Contact Person Name
- Juan Moreno Jiménez
- Contact Person Email
- juanmoreno35@hotmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Oncology
- Principal Investigator Name
- Aranzazu Gonzalez del Alba
- Principal Investigator Email
- aranzazu.gonzalezdelalba@ssib.es
- Contact Person Name
- Aranzazu Gonzalez del Alba
- Contact Person Email
- aranzazu.gonzalezdelalba@ssib.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Medical Oncology
- Principal Investigator Name
- Lucia Oliva Fernandez
- Principal Investigator Email
- luciaolifer3@gmail.com
- Contact Person Name
- Lucia Oliva Fernandez
- Contact Person Email
- luciaolifer3@gmail.com
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Miguel Angel Climent Duran
- Principal Investigator Email
- macliment@fivo.org
- Contact Person Name
- Miguel Angel Climent Duran
- Contact Person Email
- macliment@fivo.org
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Oncology
- Principal Investigator Name
- Albert Font Pous
- Principal Investigator Email
- afont@iconcologia.net
- Contact Person Name
- Albert Font Pous
- Contact Person Email
- afont@iconcologia.net
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Oncology
- Principal Investigator Name
- Carlos Alvarez Fernandez
- Principal Investigator Email
- carlos.alvfer@gmail.com
- Contact Person Name
- Carlos Alvarez Fernandez
- Contact Person Email
- carlos.alvfer@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Nuria Sala Gonzalez
- Principal Investigator Email
- nsgonzalez@iconcologia.net
- Contact Person Name
- Nuria Sala Gonzalez
- Contact Person Email
- nsgonzalez@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Daniel Castellano
- Principal Investigator Email
- cdanicas@hotmail.com
- Contact Person Name
- Daniel Castellano
- Contact Person Email
- cdanicas@hotmail.com
- Site Name
- Hospital Universitario Lucus Augusti
- Department Name
- Oncology
- Principal Investigator Name
- Sergio Vázquez Estévez
- Principal Investigator Email
- sergio.vazquez.estevez@sergas.es
- Contact Person Name
- Sergio Vázquez Estévez
- Contact Person Email
- sergio.vazquez.estevez@sergas.es
- Site Name
- Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
- Department Name
- Oncology
- Principal Investigator Name
- Ana Medina Colmenero
- Principal Investigator Email
- ana.medina@cog.es
- Contact Person Name
- Ana Medina Colmenero
- Contact Person Email
- ana.medina@cog.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Joaquin Mateo Valderrama
- Principal Investigator Email
- jmateo@vhio.net
- Contact Person Name
- Joaquin Mateo Valderrama
- Contact Person Email
- jmateo@vhio.net
Sponsor
Primary sponsor
- Full Name
- Bayer Consumer Care AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Fortrea Inc.
- Responsibilities
- Monitoring, Inv. Recruitment, Data management, SUSAR reporting, Statistical analysis, Medical writing, Adjudication
- Name
- Eramol (UK) Limited
- Responsibilities
- UK QP Oversight certificate provider for Xofigo/Radium shipments into UK Clinical Sites. Clinical doses cannot be administered until certificate received at site.
Third parties
- {"country":"United Kingdom","full_name":"Eramol (UK) Limited","duties_or_roles":"UK QP Oversight certificate provider for Xofigo/Radium shipments into UK Clinical Sites. Clinical doses cannot be administered until certificate received at site.","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Monitoring, Investigational Recruitment, Data management, SUSAR reporting, Statistical analysis, Medical writing, Adjudication","organisation_type":"Pharmaceutical company"}
Co-sponsors
- Bayer AG
Investigational products
- Investigational Product Name
- Xofigo 1100 kBq/mL solution for injection
- Active Substance
- Radium Ra 223 dichloride
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Route
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Authorisation Status
- Marketing authorisation (authorized in EU)
- Maximum Dose
- Max daily dose amount 55 KBq/Kg; max total dose amount 330 KBq/Kg
- Investigational Product Name
- ZYTIGA 500 mg film-coated tablets
- Active Substance
- Abiraterone acetate
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation (authorized in EU)
- Starting Dose
- 1000 mg daily (max daily dose amount 1000 mg documented)
- Frequency
- Daily
- Maximum Dose
- 1000 mg/day
- Investigational Product Name
- Xtandi - 40 mg soft capsules
- Active Substance
- Enzalutamide
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation (authorized in EU)
- Starting Dose
- 160 mg daily (max daily dose amount 160 mg documented)
- Frequency
- Daily
- Maximum Dose
- 160 mg/day
- Investigational Product Name
- DELTACORTENE 5 mg compresse (Prednisone)
- Active Substance
- Prednisone
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorized (marketing authorisation documented in product info)
- Starting Dose
- Up to 10 mg daily (max daily dose amount 10 mg documented)
- Frequency
- Daily
- Maximum Dose
- 10 mg/day
- Investigational Product Name
- Prednisolone 5mg Tablets (Prednisolone)
- Active Substance
- Prednisolone
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorized (marketing authorisation documented)
- Starting Dose
- Up to 10 mg daily (max daily dose amount 10 mg documented)
- Frequency
- Daily
- Maximum Dose
- 10 mg/day
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