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NCT05573789 Clinical Trial

Tumor Molecular Profiling in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05573789
Other study ID # TR19/9
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date September 1, 2022

Study information
Verified date October 2022
Source Hellenic Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date September 1, 2022
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Greece Hellenic Cooperative Oncology Group Athens

Sponsors (2)
Lead Sponsor Collaborator
Hellenic Cooperative Oncology Group NIPD Genetics

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival Time from diagnosis to the date of death, through the completion of the study 3 years
Secondary Prevalence of somatic mutations in clinically relevant genes Number of patients with somatic mutations 3 years
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