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Completed

NCT Number: NCT05573789

Tumor Molecular Profiling in Patients With Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Prostate Adenocarcinoma Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hellenic Cooperative Oncology Group

Athens, 11524, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumor molecular profiling

Genetic

Tumor molecular profiling was assessed using the ForeSENTIA® Prostate panel developed by NIPD Genetic

Other names: Next-generation sequencing

Primary outcomes

  1. Overall survival

    Time frame: 3 years

    Time from diagnosis to the date of death, through the completion of the study

Secondary outcomes

  1. Prevalence of somatic mutations in clinically relevant genes

    Time frame: 3 years

    Number of patients with somatic mutations

Sponsors and collaborators

Lead sponsor

Hellenic Cooperative Oncology Group

Other

Collaborators

  • NIPD Genetics

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Oct 10, 2022
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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