PROSABI is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with abiraterone
This study is a prospective biomarker study of patients with mCRPC undergoing treatment with abiraterone 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.
Study Type
OBSERVATIONAL
Enrollment
220
Hospital Arquitecto Marcide
Ferrol, A Coruña, Spain
To validate the independent prognostic value of the gene-expression signature from peripheral blood described by Olmos et al (Lancet Oncol 2012) on overall survival of mCRPC patients
Time frame: Initially 48 months, currently 60 months
To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival
Time frame: Initially 48 months, currently 60 months
To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al
Time frame: Initially 48 months, currently 60 months
To compare the prognostic value of the gene-expression signature described by Olmos et al versus the gene-expression signature described by Ross et al (Lancet Oncol, 2012)
Time frame: Initially 48 months, currently 60 months
To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these patients
Time frame: Initially 48 months, currently 60 months
To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts
Time frame: Initially 48 months, currently 60 months
To analyze the prognostic value of AR splicing variants, serum chromogranine and serum testosterone levels measured by ultrasensitive method in these both cohorts of patients
Time frame: Initially 48 months, currently 60 months
To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients
Time frame: Initially 48 months, currently 60 months
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Hospital Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Althaia Manresa
Manresa, Barcelona, Spain
Hospital de Especialidades de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital de Burgos
Burgos, Spain
Hospital de Ciudad Real
Ciudad Real, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
...and 14 more locations