NCT04983628

Brief Summary

We aim to employ targeted DNA NGS to evaluate the prevalence of germline and somatic mutations in cancer predisposing genes, such as BRCA1 and BRCA2, and other HR and DDR genes, including also a few additional clinically relevant genes, in patients with metastatic, locally advanced or high-grade prostate cancer. In addition, we will investigate the prognostic role of these mutations as well as their association with various clinicopathological parameters. This will be the first study investigating the prevalence of germline and somatic pathogenic mutations in Greek patients with prostate cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

February 16, 2021

Last Update Submit

February 28, 2023

Conditions

Prostate Cancer MetastaticProstate Cancer RecurrentGermline BRCA1 Gene MutationGermline BRCA2 Gene MutationMutation

Keywords

Prostate cancerPredictive biomarkerPrognostic biomarker

Outcome Measures

Primary Outcomes (1)

  • Prevalence of germline and somatic mutations in cancer predisposing genes

    Number of patients with either germline or somatic mutations

    1 year

Secondary Outcomes (1)

  • Overall survival

    3 years

Interventions

Tumor molecular profilingOTHER

targeted DNA NGS

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic, recurrent, locally advanced or "intermediate or high risk" (Gleason \>7), operable prostate cancer

You may qualify if:

  • metastatic prostate cancer
  • recurrent prostate cancer
  • locally advanced prostate cancer
  • "intermediate or high risk" (Gleason \>7), operable prostate cancer
  • available FFPE tumor tissue

You may not qualify if:

  • absence of tumor tissue available for analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hellenic Cooperative Oncology Group

Athens, 11524, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed paraffin-embedded tissue samples and germline DNA

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Elena Fountzila

    HeCOG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

July 30, 2021

Study Start

October 1, 2020

Primary Completion

January 30, 2023

Study Completion

August 1, 2023

Last Updated

March 1, 2023

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)