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Trial record 1 of 1 for:    CNIO-CP-03-2014
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PROSABI: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Abiraterone Acetate. (PROSABI)

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ClinicalTrials.gov Identifier: NCT02787837
Recruitment Status : Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Abiraterone Acetate.
Study Start Date : May 2014
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. 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 [ Time Frame: Initially 48 months, currently 60 months ]

Secondary Outcome Measures :
  1. To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival [ Time Frame: Initially 48 months, currently 60 months ]
  2. To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al [ Time Frame: Initially 48 months, currently 60 months ]
  3. 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) [ Time Frame: Initially 48 months, currently 60 months ]
  4. To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these patients [ Time Frame: Initially 48 months, currently 60 months ]
  5. To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts [ Time Frame: Initially 48 months, currently 60 months ]
  6. 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 [ Time Frame: Initially 48 months, currently 60 months ]
  7. To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients [ Time Frame: Initially 48 months, currently 60 months ]

Biospecimen Retention:   Samples With DNA
Whole blood and archival FFPE


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
metastatic Castration-Resistant Prostate Cancer patients
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787837


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

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Responsible Party: Centro Nacional de Investigaciones Oncologicas CARLOS III
ClinicalTrials.gov Identifier: NCT02787837     History of Changes
Other Study ID Numbers: CNIO-CP-03-2014
CNI-ABI-2014-02 ( Other Identifier: CNIO )
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

Keywords provided by Centro Nacional de Investigaciones Oncologicas CARLOS III:
metastatic Castration Resistant Prostate Cancer
Abiraterone Acetate
Biomarkers

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors