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

Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Abiraterone Acetate.

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

Study Overview

• Status: Unknown
• Conditions: Advanced Prostate Cancer; Abiraterone ACetate

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 Type: Observational
• Enrollment (Anticipated): 220

Contacts and Locations

Study Locations

• Spain
  • Burgos, Spain, 09006
    • Hospital de Burgos
  • Ciudad Real, Spain, 13005
    • Hospital de Ciudad Real
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Guadalajara, Spain, 19002
    • Hospital Universitario de Guadalajara
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28040
    • Hospital Universitario Clinico San Carlos
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Marañón
  • Madrid, Spain, 28050
    • Centro Integral Oncológico Clara Campal
  • Madrid, Spain, 28029
    • Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
  • Madrid, Spain, 28660
    • Hospital Madrid Sanchinarro
  • Malaga, Spain, 29010
    • Hospital Regional Universitario Virgen de la Victoria
  • Malaga, Spain, 29010
    • Anatomical Pathology PROCURE-PROSABI
  • Murcia, Spain, 30008
    • Hospital Morales Messeguer
  • Palma de Mallorca, Spain, 07120
    • Hospital Son Espases
  • Pontevedra, Spain, 36002
    • Complejo Hospitalario de Pontevedra
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe
  • A Coruña
    • Ferrol, A Coruña, Spain, 15405
      • Hospital Arquitecto Marcide
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Hospital Universitario de Santiago
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • ICO l'Hospitalet
    • Manresa, Barcelona, Spain, 08243
      • Hospital Althaia Manresa
  • Cádiz
    • Jerez de la Frontera, Cádiz, Spain, 11407
      • Hospital de Especialidades de Jerez de la Frontera
  • Málaga
    • Marbella, Málaga, Spain, 29603
      • Hospital Costa del Sol
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

metastatic Castration-Resistant Prostate Cancer patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Abiraterone Acetate; Abiraterone Acetate 1000 mg/24h plus Prednisone 5mg/12h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients	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
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 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

Collaborators and Investigators

• Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
• Investigators: Study Chair: David Olmos, Centro Nacional de Investigaciones Oncológicas

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): April 1, 2018
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 8, 2015
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Biomarkers; Abiraterone Acetate; metastatic Castration Resistant Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CNIO-CP-03-2014; CNI-ABI-2014-02 (Other Identifier: CNIO)