Tumor Molecular Profiling in Patients With Prostate Cancer

NCT ID: NCT05573789

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-09-01

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.

Conditions

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Prostate Cancer Metastatic Prostate Adenocarcinoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with prostate cancer

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.

Tumor molecular profiling

Intervention Type GENETIC

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

Interventions

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Tumor molecular profiling

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

Intervention Type GENETIC

Other Intervention Names

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Next-generation sequencing

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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NIPD Genetics

UNKNOWN

Sponsor Role collaborator

Hellenic Cooperative Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hellenic Cooperative Oncology Group

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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TR19/9

Identifier Type: -

Identifier Source: org_study_id

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