PRORADIUM: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Radium-223.
PRORADIUM
Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resitant Prostate Cancer Patients Treated With Radium-223.
2 other identifiers
observational
161
1 country
63
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2016
Longer than P75 for all trials
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 29, 2016
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedJanuary 27, 2020
February 1, 2019
2.9 years
September 29, 2016
January 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
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
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
- +2 more secondary outcomes
Study Arms (1)
Radium-223
Radium-223 55 mBq/Kg every 4 weeks IV
Interventions
Radium-223 55kBq/kg infusion IV every 4 weeks
Eligibility Criteria
metastatic Castration-Resistant Prostate Cancer
You may qualify if:
- Male age ≥ 18 years
- Histologically confirmed adenocarcinome of the prostate
- ECOG Performance Status ≤ 2
- Castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/mL (\< 2.0 nM).
- Men diagnosed with at least one metastatic lesion on CT or bone scan.
- Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
- Patients who are candidates for standard of care treatment with Radium-223 55mBq/Kg very 4 weeks intravenously
- Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
- Acceptable hematological, hepatic and renal functions.
You may not qualify if:
- Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Hospital Arquitecto Marcide
Ferrol, A Coruña, 15405, Spain
Hospital Universitario de Santiago
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
Related Publications (1)
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.
PMID: 37838555DERIVED
Biospecimen
Whole blood and FFPE
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
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 Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2016
First Posted
October 6, 2016
Study Start
February 1, 2016
Primary Completion
January 1, 2019
Study Completion
September 1, 2020
Last Updated
January 27, 2020
Record last verified: 2019-02