Clinical trial · Observational
PROSABI: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Abiraterone Acetate.
Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Abiraterone Acetate.
NCT02787837CI-TRIAL-00042987PROSABIunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abiraterone ACetate | — | UNRESOLVED | — |
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Abiraterone Acetate
- description
- Abiraterone Acetate 1000 mg/24h plus Prednisone 5mg/12h
Primary outcomes (1)
- measure
- 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
- timeFrame
- Initially 48 months, currently 60 months
Secondary outcomes (7)
- measure
- To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival
- timeFrame
- Initially 48 months, currently 60 months
- measure
- To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.