Tumor Molecular Profiling in Patients With Prostate Cancer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05573789

Enrollment

220

Registered

2022-10-10

Start date

2018-01-01

Completion date

2022-09-01

Last updated

2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Prostate Adenocarcinoma, Prostate Cancer

Keywords

tumor molecular profiling, Mutations, homologous recombination repair, BRCA2, Prognostic

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.

Interventions

GENETICTumor molecular profiling

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

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	3 years	Time from diagnosis to the date of death, through the completion of the study

Secondary

Measure	Time frame	Description
Prevalence of somatic mutations in clinically relevant genes	3 years	Number of patients with somatic mutations

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026