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Tumor Molecular Profiling in Patients With Prostate Cancer

Sponsor
Hellenic Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT05573789
Collaborator
NIPD Genetics (Other)
220
Enrollment
1
Location
56
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Tumor molecular profiling

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 Design

Study Type:
Observational
Actual Enrollment :
220 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Investigation of Mutations in DNA Damage Repair Genes and Other Actionable Molecular Aberrations as Biomarkers in Patients With Prostate Cancer
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Genetic: Tumor molecular profiling
Tumor molecular profiling was assessed using the ForeSENTIA® Prostate panel developed by NIPD Genetic
Other Names:
  • Next-generation sequencing

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [3 years]

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

    Secondary Outcome Measures

    1. Prevalence of somatic mutations in clinically relevant genes [3 years]

      Number of patients with somatic mutations

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hellenic Cooperative Oncology Group Athens Greece 11524

    Sponsors and Collaborators

    • Hellenic Cooperative Oncology Group
    • NIPD Genetics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hellenic Cooperative Oncology Group
    ClinicalTrials.gov Identifier:
    NCT05573789
    Other Study ID Numbers:
    • TR19/9
    First Posted:
    Oct 10, 2022
    Last Update Posted:
    Oct 19, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hellenic Cooperative Oncology Group
    tumor molecular profiling
    Mutations
    homologous recombination repair
    BRCA2
    Prognostic
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Oct 19, 2022