Tumor Molecular Profiling in Patients With Prostate Cancer

NCT05573789 | Completed DMC

• 1 other identifier: TR19/9
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Metastatic Prostate Adenocarcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  3 years

Secondary Outcomes (1)

• Prevalence of somatic mutations in clinically relevant genes

  3 years

Study Arms (1)

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

Interventions

Tumor molecular profiling GENETIC

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

Also known as: Next-generation sequencing

Patients with prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent locally advanced, metastatic and/or high-grade operable prostate cancer

You may qualify if:

• Metastatic prostate cancer Recurrent prostate cancer Locally advanced prostate cancer High-risk operable prostate cancer Available FFPE tumor tissue

You may not qualify if:

• Absence of tumor tissue available for analysis Lack of informed consent Lack of clinicopathological data

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead
• NIPD Genetics: collaborator

Study Sites (1)

Hellenic Cooperative Oncology Group

Athens, 11524, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

FFPE tumor blocks from patients with recurrent locally advanced, metastatic and/or high-grade operable prostate cancer

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: September 1, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)