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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

Study Description
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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

Condition or disease
Advanced Prostate Cancer Cabazitaxel Docetaxel

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 Design
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Study Type : Observational
Estimated Enrollment : 402 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 Docetaxel or Cabazitaxel.
Study Start Date : May 2014
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort
Docetaxel
Docetaxel 75mg/m2 IV every 3 weeks
Cabazitaxel
Cabazitaxel 20-25mg/m2 IV every 3 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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: 48 months ]
  2. To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al [ Time Frame: 48 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: 48 months ]
  4. 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 ]
  5. To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts [ Time Frame: 48 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: 48 months ]
  7. To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients [ Time Frame: 48 months ]

Biospecimen Retention:   Samples With DNA
Whole blood and FFPE tissue

Eligibility Criteria
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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
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 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
Contacts and Locations
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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): NCT02362620


Locations
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Sponsors and Collaborators
Centro Nacional de Investigaciones Oncologicas CARLOS III
Investigators
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Principal Investigator: David Olmos, MD, PhD Head of Prostate Cancer Clinical Research Unit CNIO
More Information
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Responsible Party: Centro Nacional de Investigaciones Oncologicas CARLOS III
ClinicalTrials.gov Identifier: NCT02362620    
Other Study ID Numbers: CNI-DOC-2014-02
CNIO-CP-02-2014 ( Other Identifier: CNIO )
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Keywords provided by Centro Nacional de Investigaciones Oncologicas CARLOS III:
metastatic Castration Resistant Prostate Cancer
Taxanes
Biomarkers
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases