PROSENZA: Prospective Multi-Centre Study of Prognostic Factors in mCRPC Patients Treated With Enzalutamide.

Study Overview
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Brief Summary
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PROSENZA is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with enzalutamide

Detailed Description
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This study is a prospective biomarker study of patients with mCRPC undergoing treatment with enzalutamide 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 Enzalutamide.

Conditions
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Advanced Prostate Cancer, Castration Resistant, Enzalutamide

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male age ≥ 18 years Histologically confirmed adenocarcinoma 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 enzalutamide 160 mg every 24 hours. 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 |
| --- | --- |
| Enzalutamide<br>Enzalutamide 160 mg/day c/24h | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients |  | Initially 48 months, currently 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze the correlation between biochemical and/or radiological response with AR-V7 expression and/or AR amplification in mCRPC patients treated with Enzalutamide. |  | Initially 48 months, currently 60 months | 
| To assess AR-V7 expression and/or AR amplification changes before and after enzalutamide treatment |  | Initially 48 months, currently 60 months | 
| To explore the correlation between AR-V7 expression and AR amplification with other biomarkers as testosterone serum levels, PTEN loss or TMPRSS-ERG fusions in mCRPC patients treated with Enzalutamide |  | 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 |  | Initially 48 months, currently 60 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, Enzalutamide, Biomarkers