Genetics of Prostate Cancer in Young Patients

Completed

• Conditions: Prostate Carcinoma

• Registration Number: NCT06714227
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The aim of the study is to identify genetic variants in genes responsible or potentially responsible for the etiology of prostate cancer in a population of patients with early onset of the malignancy.

Detailed Description

The data collected from the study will provide a preliminary picture of the prevalence and type of germline pathological variants in the context of early-onset prostate cancer in the Italian population. In addition, alterations in DNA repair genes other than BRCA1-2 and ATM, including any genes yet undescribed as causative or predisposing, have yet to be explored in detail: in many cases the significance of variants is not well defined in terms of pathogenicity, prognostic value, and predictive indicator of response to different treatments. Therefore, an extensive mutational analysis-even if performed on a limited number of patients-can generate a large number of variants for evaluation, bringing knowledge about the relationship between these variants and the onset of malignancy The information obtained, although merely exploratory, may indicate the desirability of conducting systematic genetic investigations in this particular patient population in the future, especially in view of the new therapeutic strategies available such as immunotherapy or PARP inhibitors

Study Timeline

• Study Start: 2023-09-25
• Primary Completion: 2024-06-11
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Patients with histologic or cytologic diagnosis of prostate cancer
• Age ≥18 years and ≤55 years at first diagnosis of prostate carcinoma
• Availability of clinical and instrumental data related to prostate cancer
• Patients who knowingly express willingness to participate in the study after signing written informed consent

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence/absence and type of pathogenic/probably pathogenic germline variants in genes previously implicated in prostate cancer etiology	4 years	molecular analysis of genomic DNA

Secondary Outcome Measures

Name	Time	Method
Presence/absence and type of variants in genes potentially implicated in the etiology of prostate cancer (candidate genes).	4 years	molecular analysis of genomic DNA

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy