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| ID | Type | Description | Link |
|---|---|---|---|
| CNI-ABI-2014-02 | Other Identifier | CNIO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone Acetate | Abiraterone Acetate 1000 mg/24h plus Prednisone 5mg/12h |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Initially 48 months, currently 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival | Initially 48 months, currently 60 months | |
| To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al |
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Inclusion Criteria:
Exclusion Criteria:
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metastatic Castration-Resistant Prostate Cancer patients
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| Name | Affiliation | Role |
|---|---|---|
| David Olmos | Centro Nacional de Investigaciones Oncológicas | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Arquitecto Marcide | Ferrol | A Coruña | 15405 | Spain | ||
| Hospital Universitario de Santiago |
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Whole blood and archival FFPE
| 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) | 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 | Initially 48 months, currently 60 months |
| To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts | 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 | 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 |
| Santiago de Compostela |
| A Coruña |
| 15706 |
| Spain |
| ICO L'Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Althaia Manresa | Manresa | Barcelona | 08243 | Spain |
| Hospital de Especialidades de Jerez de la Frontera | Jerez de la Frontera | Cádiz | 11407 | Spain |
| Hospital Costa del Sol | Marbella | Málaga | 29603 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital de Burgos | Burgos | 09006 | Spain |
| Hospital de Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Universitario de Guadalajara | Guadalajara | 19002 | Spain |
| Hospital Universitario Gregorio Maranon | Madrid | 28007 | 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 |
| Centro Integral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Hospital Madrid Sanchinarro | Madrid | 28660 | Spain |
| Anatomical Pathology PROCURE-PROSABI | Málaga | 29010 | Spain |
| Hospital Regional Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Morales Messeguer | Murcia | 30008 | Spain |
| Hospital Son Espases | Palma de Mallorca | 07120 | Spain |
| Complejo Hospitalario de Pontevedra | Pontevedra | 36002 | Spain |
| Hospital Universitario La Fe | Valencia | 46026 | Spain |