Prospective Multi-Centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Enzalutamide.

Centro Nacional de Investigaciones Oncologicas CARLOS III26 sites in 1 country187 target enrollmentJune 2016

ConditionsAdvanced Prostate Cancer Castration Resistant Enzalutamide

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Advanced Prostate Cancer
Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
Enrollment: 187
Locations: 26
Primary Endpoint: To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

June 2016

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 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

Outcomes

Primary Outcomes

To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients

Time Frame: Initially 48 months, currently 60 months

Secondary Outcomes

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 validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these patients(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)