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

C

Centro Nacional de Investigaciones Oncologicas CARLOS III

Status

Unknown

Conditions

Abiraterone ACetate
Advanced Prostate Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT02787837
CNI-ABI-2014-02 (Other Identifier)
CNIO-CP-03-2014

Details and patient eligibility

About

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

Full 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.

Enrollment

220 estimated patients

Sex

Male

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

220 participants in 1 patient group

Abiraterone Acetate
Description:
Abiraterone Acetate 1000 mg/24h plus Prednisone 5mg/12h

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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