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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advanced Prostate Cancer, Cabazitaxel, Docetaxel

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Docetaxel<br>Docetaxel 75mg/m2 IV every 3 weeks | |
| Cabazitaxel<br>Cabazitaxel 20-25mg/m2 IV every 3 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 correlate the presence of somatic and/or germinal mutations with the outcomes of these patients |  | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic Castration Resistant Prostate Cancer, Taxanes, Biomarkers