PRORADIUM: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Radium-223.
- Conditions
- Advanced Prostate CancerRadium 223Castration Resistant
- Interventions
- Drug: Radium 223 55mBq/Kg every 4 weeks intravenously
- Registration Number
- NCT02925702
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 161
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Radium-223 Radium 223 55mBq/Kg every 4 weeks intravenously Radium-223 55 mBq/Kg every 4 weeks IV
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 analyze the prognostic value of "Bone Scan Index" in mCRPC patients treated with Radium-223 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 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 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
Trial Locations
- Locations (63)
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Hospital Universitario de Elche
🇪🇸Elche, Alicante, Spain
Hospital San Llatzer
🇪🇸Palma de Mallorca, Islas Baleares, Spain
Hospital Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital Lluis Alcanyis
🇪🇸Xátiva, Valencia, Spain
Hospital Puerta del Mar
🇪🇸Cádiz, Spain
Hospital Universitario de Guadalajara
🇪🇸Guadalajara, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Hospital Althaia Manresa
🇪🇸Manresa, Barcelona, Spain
Hospital Costa del Sol
🇪🇸Marbella, Málaga, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Complejo Hospitalario Universitario de Vigo
🇪🇸Vigo, Pontevedra, Spain
Hospital Arquitecto Marcide
🇪🇸Ferrol, A Coruña, Spain
Hospital Universitario de Santiago
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario Quirón
🇪🇸Pozuelo de Alarcón, Madrid, Spain
Hospital Infanta Sofía
🇪🇸San Sebastián de los Reyes, Madrid, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
ICO L'Hospitalet
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Onkologikoa, Instituto Oncológico de Kutxa
🇪🇸Donostia, Guipúzcoa, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
🇪🇸Las Palmas, Las Palmas De Gran Canaria, Spain
Fundacion Centro Oncologico de Galicia
🇪🇸A Coruna, Spain
Hospital Moisès Broggi
🇪🇸Sant Joan Despí, Barcelona, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Tenerife, Spain
Hospital de Especialidades de Jerez de la Frontera
🇪🇸Jerez de la Frontera, Cádiz, Spain
Hospital Universitario Vall D'Hebron
🇪🇸Barcelona, Spain
Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
🇪🇸Madrid, Spain
Hospital de Ciudad Real
🇪🇸Ciudad Real, Spain
Anatomical Pathology PROCURE
🇪🇸Malaga, Spain
Complejo Hospitalario de Pontevedra
🇪🇸Pontevedra, Spain
Hospital Universxitario Nuestra Señora de Valme
🇪🇸Sevilla, Spain
Hospital San Pedro de La Rioja
🇪🇸Logroño, La Rioja, Spain
Hospital de Burgos
🇪🇸Burgos, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Nuclear Medicine Coordination PROCURE-PRORADIUM
🇪🇸Barcelona, Spain
Hospital San Pedro de Alcántara
🇪🇸Cáceres, Spain
Instituto Catalán de Oncología de Girona-ICO Girona
🇪🇸Girona, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
CNIO-Centro Nacional de Investigaciones Oncológicas
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Lucus Augusti
🇪🇸Lugo, Spain
Hospital Morales Messeguer
🇪🇸Murcia, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Spain
Hospital Clínico de Salamanca
🇪🇸Salamanca, Spain
Fundación Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Centro Integral Oncologico Clara Campal
🇪🇸Madrid, Spain
Hospital Regional Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
Complejo Hospitalario Universitario de Ourense
🇪🇸Ourense, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Nuestra Señora de Sonsoles
🇪🇸Ávila, Spain
Hospital Virgen de la Salud-Complejo Hospitalario de Toledo
🇪🇸Toledo, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Arnau Vilanova
🇪🇸Valencia, Spain
Hospital de Mataró
🇪🇸Mataró, Barcelona, Spain
Consorci Sanitari de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Fundación Hospital de Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Hospital Universitario Clinico San Carlos
🇪🇸Madrid, Spain