Prostate Cancer Clinical Trial
Official title:
Prospective Multicentre Cohort Study of the Prevalence and Clinical Impact of Germline Deleterious Mutations in DNA Repair Genes of Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
PROREPAIR is a prospective multicenter observational cohort study of unselected patients with
metastatic Castration Resistant Prostate Cancer (mCRPC) with unknown germline mutational
status at study entry and who are candidates to start 1st line treatment with any approved
survival-prolonging agent.
The study aims to evaluate the impact of aberrations in DNA-repair genes,(BRCA1, BRCA2, ATM
and PALB2 and other genes) on cause-specific survival from the diagnosis of the metastatic
castration resistant status and other outcomes.
This is a non-interventional study in which eligible patients are prospectively followed-up
until death or the end-of-study, whichever happens first.
Patients are enrolled after mCRPC diagnosis and before or within the 6 first months of
starting a first-line treatment with any approved survival-prolonging agent for mCRPC. First
and subsequent treatment lines will be chosen according to the patients and their treating
physicians preferences and will not be dictated by this study.
A whole blood sample for germline DNA extraction as well as any available archival prostate
cancer tissue samples will be collected at baseline. Optional plasma, serum and whole blood
samples will be collected at baseline and at different time points along the evolution of the
disease. A sample will be collected within the last 6 months of life.
Survival and treatment outcomes including biochemical, radiological and clinical progression
with standard approved agents abiraterone, enzalutamide, docetaxel, cabazitaxel and
radium-223 will be prospectively collected.
Primary aim is to evaluate the prevalence and impact of DNA repair germline mutations in the
BRCA1, BRCA2, ATM and PALB2 genes on cause-specific survival from mCRPC. Secondary aims will
include the correlation of additional germline alterations in DNA-repair with survival and
treatment outcomes; the analyses of the survival and treatment outcomes impact of somatic
alterations in these genes and the role of germline and somatic defects in the clonal
evolution of prostate cancer.
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