Tumor Molecular Profiling in Patients With Prostate Cancer

Completed

• Conditions: Metastatic Prostate Adenocarcinoma; Prostate Cancer
• Interventions: Genetic: Tumor molecular profiling

• Registration Number: NCT05573789
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2022-09-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with prostate cancer	Tumor molecular profiling	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	3 years	Time from diagnosis to the date of death, through the completion of the study

Secondary Outcome Measures

Name	Time	Method
Prevalence of somatic mutations in clinically relevant genes	3 years	Number of patients with somatic mutations

Trial Locations

Locations (1)

Hellenic Cooperative Oncology Group; 🇬🇷 Athens, Greece