Tumor Molecular Profiling in Patients With Prostate Cancer

Study Overview
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Brief Summary
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The aim of the study was to evaluate the prevalence, the prognostic and predictive value of gene alterations in unselected patients with prostate cancer. Patients with histologically confirmed prostate cancer, treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments, were included. The presence of gene alterations was assessed using the ForeSENTIA® Prostate panel developed by NIPD Genetic.

Detailed Description
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Data on tumor molecular profiling of European patients with prostate cancer is limited. The aim of the study was to evaluate the prevalence, the prognostic and predictive value of gene alterations in unselected patients with prostate cancer. Patients with histologically confirmed prostate cancer, treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments, were included. The presence of gene alterations was assessed using the ForeSENTIA® Prostate panel developed by NIPD Genetic. The primary endpoint was the prevalence of gene alterations in homologous recombination repair (HRR) genes. Secondary endpoint was overall survival.

Official Title
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Investigation of Mutations in DNA Damage Repair Genes and Other Actionable Molecular Aberrations as Biomarkers in Patients With Prostate Cancer

Conditions
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Prostate Cancer, Metastatic Prostate Adenocarcinoma

Intervention / Treatment
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* Genetic: Tumor molecular profiling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic prostate cancer Recurrent prostate cancer Locally advanced prostate cancer High-risk operable prostate cancer Available FFPE tumor tissue Exclusion Criteria: Absence of tumor tissue available for analysis Lack of informed consent Lack of clinicopathological data

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Patients with prostate cancer<br>Patients with recurrent locally advanced, metastatic and/or high-grade operable prostate cancer and available formalin-fixed paraffin-embedded tumor tissue. Patients received treatment at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology. Tumor molecular profiling was performed. | Genetic: Tumor molecular profiling<br>* Tumor molecular profiling was assessed using the ForeSENTIA® Prostate panel developed by NIPD Genetic<br>* Other names: Next-generation sequencing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from diagnosis to the date of death, through the completion of the study | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of somatic mutations in clinically relevant genes | Number of patients with somatic mutations | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor molecular profiling, Mutations, homologous recombination repair, BRCA2, Prognostic