Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787837
Recruitment Status : Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Centro Nacional de Investigaciones Oncologicas CARLOS III

Tracking Information
First Submitted Date October 8, 2015
First Posted Date June 1, 2016
Last Update Posted Date January 27, 2020
Study Start Date May 2014
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2019)
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 ]
Original Primary Outcome Measures
 (submitted: May 26, 2016)
Prognostic value for global survival [ Time Frame: through study completion, an average of 2 years ]
Independently validate the prognostic value for global survival of the expression signature in peripheral blood of nine genes characterised by Olmos et al. (Lancet Oncol., 2012) in two cohorts of patients with castration-resistant prostate cancer (CRPC) who are candidates for treatment with abiraterone acetate
Change History
Current Secondary Outcome Measures
 (submitted: February 1, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts [ Time Frame: 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 [ Time Frame: Initially 48 months, currently 60 months ]
  • To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients [ Time Frame: Initially 48 months, currently 60 months ]
Original Secondary Outcome Measures
 (submitted: May 26, 2016)
  • Prognostic value for the progression-free survival [ Time Frame: through study completion, an average of 2 years ]
    Analyse the prognostic value for the progression-free survival (PSA and radiological) of the expression signature described by Olmos et al. (Lancet Oncol., 2012). Increased PSA units (ng/mL) and radiologic according RECIST 1.1
  • Global survival of the early changes [ Time Frame: through study completion, an average of 2 years ]
    Study the prognostic value for global survival of the early changes (prior to receiving the third cycle of treatment) in expression signatures described by Olmos et al. (Lancet Oncol., 2012).
  • Prognostic value for global survival [ Time Frame: through study completion, an average of 2 years ]
    Evaluate the prognostic value for global survival (PSA and radiological) of the early changes in expression signatures described by Olmos et al. (Lancet Oncol., 2012). Increased PSA units (ng/mL) and radiologic according RECIST 1.1
  • Prognostic and predictive utility of the expression signature [ Time Frame: through study completion, an average of 2 years ]
    Compare the prognostic and predictive utility of the expression signature described by Olmos et al. (Lancet Oncol., 2012) with that described by Ross et al., (Lancet Oncol., 2012).
  • Prognostic nomograms described for CRPC [ Time Frame: through study completion, an average of 2 years ]
    Validate in this patient cohorts treated with abiraterone, the prognostic nomograms described for CRPC in terms of the clinical, pathological and analytical variables recognised and recorded in the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PROSABI: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Abiraterone Acetate.
Official Title Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Abiraterone Acetate.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood and archival FFPE
Sampling Method Non-Probability Sample
Study Population metastatic Castration-Resistant Prostate Cancer patients
Condition
  • Advanced Prostate Cancer
  • Abiraterone ACetate
Intervention Not Provided
Study Groups/Cohorts Abiraterone Acetate
Abiraterone Acetate 1000 mg/24h plus Prednisone 5mg/12h
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 1, 2018)
220
Original Estimated Enrollment
 (submitted: May 26, 2016)
208
Estimated Study Completion Date December 2020
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02787837
Other Study ID Numbers CNIO-CP-03-2014
CNI-ABI-2014-02 ( Other Identifier: CNIO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centro Nacional de Investigaciones Oncologicas CARLOS III
Study Sponsor Centro Nacional de Investigaciones Oncologicas CARLOS III
Collaborators Not Provided
Investigators
Study Chair: David Olmos Centro Nacional de Investigaciones Oncológicas
PRS Account Centro Nacional de Investigaciones Oncologicas CARLOS III
Verification Date January 2020