PRORADIUM: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Radium-223.
NCT ID: NCT02925702
Last Updated: 2020-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
161 participants
OBSERVATIONAL
2016-02-29
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Radium-223
Radium-223 55 mBq/Kg every 4 weeks IV
Radium 223 55mBq/Kg every 4 weeks intravenously
Radium-223 55kBq/kg infusion IV every 4 weeks
Interventions
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Radium 223 55mBq/Kg every 4 weeks intravenously
Radium-223 55kBq/kg infusion IV every 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed adenocarcinome of the prostate
3. ECOG Performance Status ≤ 2
4. Castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/mL (\< 2.0 nM).
5. Men diagnosed with at least one metastatic lesion on CT or bone scan.
6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
7. Patients who are candidates for standard of care treatment with Radium-223 55mBq/Kg very 4 weeks intravenously
8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
9. Acceptable hematological, hepatic and renal functions.
Exclusion Criteria
2. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
18 Years
99 Years
MALE
No
Sponsors
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
OTHER
Centro Nacional de Investigaciones Oncologicas CARLOS III
OTHER
Responsible Party
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Principal Investigators
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David Olmos, MD
Role: STUDY_CHAIR
CNIO-Centro Nacionald e Investigaciones Oncológicas
Elena Castro, MD
Role: STUDY_CHAIR
CNIO-Centro Nacionald e Investigaciones Oncológicas
Rafael Morales, MD
Role: STUDY_CHAIR
Hospital Vall d'Hebron
Maria Isabel Saez, MD
Role: STUDY_CHAIR
Hospital Universitario Virgen de la Victoria
Locations
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Hospital Arquitecto Marcide
Ferrol, A Coruña, Spain
Hospital Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital Universitario de Elche
Elche, Alicante, Spain
Hospital San Llatzer
Palma de Mallorca, Balearic Islands, Spain
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Althaia Manresa
Manresa, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital Parc Taulí
Sabadell, Barcelona, Spain
Hospital Moisès Broggi
Sant Joan Despí, Barcelona, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital de Especialidades de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Onkologikoa, Instituto Oncológico de Kutxa
Donostia / San Sebastian, Guipúzcoa, Spain
Hospital San Pedro de La Rioja
Logroño, La Rioja, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas, Las Palmas de Gran Canaria, Spain
Fundación Hospital de Alcorcón
Alcorcón, Madrid, Spain
Hospital Universitario Quirón
Pozuelo de Alarcón, Madrid, Spain
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital Lluis Alcanyis
Xátiva, Valencia, Spain
Fundacion Centro Oncologico de Galicia
A Coruña, , Spain
Hospital Nuestra Señora de Sonsoles
Ávila, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Vall D'Hebron
Barcelona, , Spain
Nuclear Medicine Coordination PROCURE-PRORADIUM
Barcelona, , Spain
Hospital de Burgos
Burgos, , Spain
Hospital Puerta del Mar
Cadiz, , Spain
Hospital San Pedro de Alcántara
Cáceres, , Spain
Hospital de Ciudad Real
Ciudad Real, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Instituto Catalán de Oncología de Girona-ICO Girona
Girona, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario de Guadalajara
Guadalajara, , Spain
Complejo Hospitalario de Jaén
Jaén, , Spain
Hospital Lucus Augusti
Lugo, , Spain
Hospital Universitario Gregorio Maranon
Madrid, , Spain
CNIO-Centro Nacional de Investigaciones Oncológicas
Madrid, , Spain
Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Anatomical Pathology PROCURE
Málaga, , Spain
Hospital Regional Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Morales Messeguer
Murcia, , Spain
Complejo Hospitalario Universitario de Ourense
Ourense, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Complejo Hospitalario de Pontevedra
Pontevedra, , Spain
Hospital Clínico de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universxitario Nuestra Señora de Valme
Seville, , Spain
Hospital Virgen de la Salud-Complejo Hospitalario de Toledo
Toledo, , Spain
Fundación Instituto Valenciano de Oncología
Valencia, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Arnau Vilanova
Valencia, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Clínico Lozano Blesa
Zaragoza, , Spain
Countries
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References
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Romero-Laorden N, Lorente D, de Velasco G, Lozano R, Herrera B, Puente J, Lopez PP, Medina A, Almagro E, Gonzalez-Billalabeitia E, Villla-Guzman JC, Gonzalez-Del-Alba A, Borrega P, Lainez N, Fernandez-Freire A, Hernandez A, Rodriguez-Vida A, Chirivella I, Fernandez-Parra E, Lopez-Campos F, Isabel Pacheco M, Morales-Barrera R, Fernandez O, Villatoro R, Luque R, Hernando S, Castellano DC, Castro E, Olmos D. Prospective Assessment of Bone Metabolism Biomarkers and Survival in Metastatic Castration-resistant Prostate Cancer Patients Treated with Radium-223: The PRORADIUM Study. Eur Urol Oncol. 2024 Jun;7(3):447-455. doi: 10.1016/j.euo.2023.09.015. Epub 2023 Oct 12.
Other Identifiers
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CNI-RAD-2016-01
Identifier Type: OTHER
Identifier Source: secondary_id
IBIMA-CNIO-CP-03-2015
Identifier Type: -
Identifier Source: org_study_id
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