PROSABI: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Abiraterone Acetate.

• Conditions: Advanced Prostate Cancer; Abiraterone ACetate

• Registration Number: NCT02787837
• Lead Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-01
• Primary Completion: 2018-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 220

Inclusion Criteria

1. Male age ≥ 18 years
2. Histologically confirmed adenocarcinome of the prostate
3. ECOG Performance Status ≤ 2
4. Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/mL (< 2.0 nM).
5. Men diagnosed with at least one metastatic lesion on CT or bone scan.
6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
7. Patients who are candidates for standard of care treatment with abiraterone acetate: 1000 mg every 24 hours plus prednisone 5 mg every 12 hours.
8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
9. Acceptable hematological, hepatic and renal functions.9. Acceptable haematological, hepatic and renal functions.

Exclusion Criteria

1. 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.
2. 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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al	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
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 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 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 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 the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival	Initially 48 months, currently 60 months

Trial Locations

Locations (24)

Hospital Arquitecto Marcide; 🇪🇸 Ferrol, A Coruña, Spain

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; 🇪🇸 La Laguna, Tenerife, Spain

Hospital de Burgos; 🇪🇸 Burgos, Spain

Hospital de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario Reina Sofia; 🇪🇸 Cordoba, Spain

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