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| ID | Type | Description | Link |
|---|---|---|---|
| CNI-RAD-2016-01 | Other Identifier | CNIO |
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| Name | Class |
|---|---|
| Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | OTHER |
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PRORADIUM is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with radium-223.
This study is a prospective biomarker study of patients with mCRPC undergoing treatment with radium-223 as standard of care treatment. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radium-223 | Radium-223 55 mBq/Kg every 4 weeks IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium 223 55mBq/Kg every 4 weeks intravenously | Drug | Radium-223 55kBq/kg infusion IV every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To validate the prognostic value for overall survival of serum bone metabolism markers descibed by Primo N Lara et al (JNCI 2014) in mCRPC patients treated with Radium-223 | Initially 48 months, currently 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| To analyze the prognostic value for biochemical and/or radiological progression-free survival of serum bone metabolism markers described by Primo N Lara et al in mCRPC patients treated with Radium-223 | Initially 48 months, currently 60 months | |
| To assess the prognostic value of alkaline phosphatase before- and after 3 cycles of treatment in these patients |
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Inclusion Criteria:
Exclusion Criteria:
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metastatic Castration-Resistant Prostate Cancer
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| Name | Affiliation | Role |
|---|---|---|
| David Olmos, MD | CNIO-Centro Nacionald e Investigaciones Oncológicas | Study Chair |
| Elena Castro, MD | CNIO-Centro Nacionald e Investigaciones Oncológicas | Study Chair |
| Rafael Morales, MD | Hospital Vall d'Hebron | Study Chair |
| Maria Isabel Saez, MD | Hospital Universitario Virgen de la Victoria | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Arquitecto Marcide | Ferrol | A Coruña | 15405 | Spain | ||
| Hospital Universitario de Santiago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37838555 | Derived | 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. |
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Whole blood and FFPE
| Initially 48 months, currently 60 months |
| To analyze the prognostic value of "Bone Scan Index" in mCRPC patients treated with Radium-223 | Initially 48 months, currently 60 months |
| To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients treated with Radium-223 | Initially 48 months, currently 60 months |
| To validate the prognostic value of the gene-expression signature from peripheral blood described by Olmos et al (Lancet Oncol 2012) on overall survival of mCRPC patients | Initially 48 months, currently 60 months |
| To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients | Initially 48 months, currently 60 months |
| Exploratory aims include: Validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients and analyze the prognostic value of the gene-expression signature described by Olmos et al on progression-free survival. | Initially 48 months, currently 60 months |
| Santiago de Compostela |
| A Coruña |
| 15706 |
| Spain |
| Hospital Universitario de Elche | Elche | Alicante | 03203 | Spain |
| Hospital San Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| ICO L'Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Althaia Manresa | Manresa | Barcelona | 08243 | Spain |
| Hospital de Mataró | Mataró | Barcelona | 08304 | Spain |
| Hospital Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Hospital Moisès Broggi | Sant Joan Despí | Barcelona | 08907 | Spain |
| Consorci Sanitari de Terrassa | Terrassa | Barcelona | 08227 | Spain |
| Hospital Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital de Especialidades de Jerez de la Frontera | Jerez de la Frontera | Cádiz | 11407 | Spain |
| Hospital Onkologikoa, Instituto Oncológico de Kutxa | Donostia / San Sebastian | Guipúzcoa | 20014 | Spain |
| Hospital San Pedro de La Rioja | Logroño | La Rioja | 26006 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrín | Las Palmas | Las Palmas de Gran Canaria | 35010 | Spain |
| Fundación Hospital de Alcorcón | Alcorcón | Madrid | 28922 | Spain |
| Hospital Universitario Quirón | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Infanta Sofía | San Sebastián de los Reyes | Madrid | 28702 | Spain |
| Hospital Costa del Sol | Marbella | Málaga | 29603 | Spain |
| Clínica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Complejo Hospitalario de Navarra | Pamplona | Navarre | 31008 | Spain |
| Complejo Hospitalario Universitario de Vigo | Vigo | Pontevedra | 36200 | Spain |
| Hospital Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital Lluis Alcanyis | Xátiva | Valencia | 46800 | Spain |
| Fundacion Centro Oncologico de Galicia | A Coruña | 15009 | Spain |
| Hospital Nuestra Señora de Sonsoles | Ávila | 05004 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario Vall D'Hebron | Barcelona | 08035 | Spain |
| Nuclear Medicine Coordination PROCURE-PRORADIUM | Barcelona | Spain |
| Hospital de Burgos | Burgos | 09006 | Spain |
| Hospital Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital San Pedro de Alcántara | Cáceres | 10003 | Spain |
| Hospital de Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Instituto Catalán de Oncología de Girona-ICO Girona | Girona | 17007 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Universitario de Guadalajara | Guadalajara | 19002 | Spain |
| Complejo Hospitalario de Jaén | Jaén | 23007 | Spain |
| Hospital Lucus Augusti | Lugo | 27003 | Spain |
| Hospital Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| CNIO-Centro Nacional de Investigaciones Oncológicas | Madrid | 28029 | Spain |
| Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas | Madrid | 28029 | Spain |
| Hospital Universitario Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28041 | Spain |
| Centro Integral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Anatomical Pathology PROCURE | Málaga | 29010 | Spain |
| Hospital Regional Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Morales Messeguer | Murcia | 30008 | Spain |
| Complejo Hospitalario Universitario de Ourense | Ourense | 32005 | Spain |
| Hospital Son Espases | Palma de Mallorca | 07120 | Spain |
| Complejo Hospitalario de Pontevedra | Pontevedra | 36002 | Spain |
| Hospital Clínico de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Universxitario Nuestra Señora de Valme | Seville | 41014 | Spain |
| Hospital Virgen de la Salud-Complejo Hospitalario de Toledo | Toledo | 45071 | Spain |
| Fundación Instituto Valenciano de Oncología | Valencia | 46009 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Arnau Vilanova | Valencia | 46015 | Spain |
| Hospital Universitario La Fe | Valencia | 46026 | Spain |
| Hospital Clínico Lozano Blesa | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
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