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PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel. (PROSTAC)

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ClinicalTrials.gov Identifier: NCT02362620
Recruitment Status : Unknown
Verified January 2020 by Centro Nacional de Investigaciones Oncologicas CARLOS III.
Recruitment status was:  Active, not recruiting
First Posted : February 13, 2015
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Centro Nacional de Investigaciones Oncologicas CARLOS III

Tracking Information
First Submitted Date February 9, 2015
First Posted Date February 13, 2015
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 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: 48 months ]
Original Primary Outcome Measures
 (submitted: February 12, 2015)		 prognostic value for global survival [ Time Frame: months ]
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 Taxotere o cabazitaxel
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: 48 months ]
  • To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al [ Time Frame: 48 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: 48 months ]
  • To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these both cohorts of patients [ Time Frame: 48 months ]
  • To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts [ Time Frame: 48 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: 48 months ]
  • To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients [ Time Frame: 48 months ]
Original Secondary Outcome Measures
 (submitted: February 12, 2015)
  • progression-free survival [ Time Frame: months ]
    Analyse (in an independent and joint manner in the two cohorts) the prognostic value for the progression-free survival (PSA and radiological) of the expression signature described by Olmos et al. (Lancet Oncol., 2012).
  • global survival of the early changes [ Time Frame: months ]
    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) in an independent and joint manner in the two cohorts.
  • prognostic value for global survival [ Time Frame: months ]
    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) in an independent and joint manner in the two cohorts.
  • biochemical response to the treatment [ Time Frame: months ]
    Study the asociation or not of the for biochemical response to the treatment with the expression signature described by Olmos et al. (Lancet Oncol., 2012) in an independent and joint manner in the two cohorts
  • prognostic and predictive utilit [ Time Frame: months ]
    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) in an independent and joint manner in the two cohorts.
  • prognostic nomograms described for CRPC [ Time Frame: months ]
    Validate in these two patient cohorts treated with docetaxel or cabazitaxel, the prognostic nomograms described for CRPC in terms of the clinical, pathological and analytical variables recognised and recorded in the study. The analysis will be perform in an independent and joint manner in the two cohorts.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel.
Official Title Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Docetaxel or Cabazitaxel.
Brief Summary PROSTAC is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with docetaxel or cabazitaxel
Detailed Description This study is a prospective biomarker study of patients with mCRPC undergoing treatment with docetaxel or cabazitaxel 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 FFPE tissue
Sampling Method Non-Probability Sample
Study Population Castration-Resistant Prostate Cancer patients
Condition
  • Advanced Prostate Cancer
  • Cabazitaxel
  • Docetaxel
Intervention Not Provided
Study Groups/Cohorts
  • Docetaxel
    Docetaxel 75mg/m2 IV every 3 weeks
  • Cabazitaxel
    Cabazitaxel 20-25mg/m2 IV every 3 weeks
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 Unknown status
Estimated Enrollment
 (submitted: February 12, 2015)		 402
Original Estimated Enrollment Same as current
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 docetaxel 75mg/m2 every 3 weeks or cabazitaxel 20-25mg/m2 every 3 weeks intravenously.
  8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
  9. Acceptable hematological, 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 NCT02362620
Other Study ID Numbers CNI-DOC-2014-02
CNIO-CP-02-2014 ( Other Identifier: CNIO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Centro Nacional de Investigaciones Oncologicas CARLOS III
Original Responsible Party Same as current
Current Study Sponsor Centro Nacional de Investigaciones Oncologicas CARLOS III
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: David Olmos, MD, PhD Head of Prostate Cancer Clinical Research Unit CNIO
PRS Account Centro Nacional de Investigaciones Oncologicas CARLOS III
Verification Date January 2020