Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Docetaxel or Cabazitaxel.

Centro Nacional de Investigaciones Oncologicas CARLOS III25 sites in 1 country402 target enrollmentMay 2014

ConditionsAdvanced Prostate Cancer Cabazitaxel Docetaxel

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Advanced Prostate Cancer
Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
Enrollment: 402
Locations: 25
Primary Endpoint: 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
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

December 2020

Last Updated

6 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Centro Nacional de Investigaciones Oncologicas CARLOS III

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male age ≥ 18 years
•Histologically confirmed adenocarcinome of the prostate
•ECOG Performance Status ≤ 2
•Castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/mL (\< 2.0 nM).
•Men diagnosed with at least one metastatic lesion on CT or bone scan.
•Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.
•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.
•Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.
•Acceptable hematological, hepatic and renal functions.

Exclusion Criteria

•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.
•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

Outcomes

Primary Outcomes

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 Outcomes

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(48 months)
To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival(48 months)
To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al(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)(48 months)
To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these both cohorts of patients(48 months)
To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts(48 months)
To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients(48 months)