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OpenTrials
Completed

NCT Number: NCT06714227

Genetics of Prostate Cancer in Young Patients

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Molecular analysis of genomic DNA (exome sequencing) from peripheral blood sample

Genetic

The first level of investigation will focus on genes already described in cases of pathogenic germline variants of prostate cancer and/or DNA repair system genes. The second level of investigation will consider variants in genes known to confer increased risk of cancer development, e.g., genes listed in the UK health system's solid tumor predisposition gene panel. Finally, pathogenic/probably pathogenic variants in the exome in genes attributable to increased risk will be evaluated on the basis of molecular pathway and findings in the scientific literature.

Primary outcomes

  1. Presence/absence and type of pathogenic/probably pathogenic germline variants in genes previously implicated in prostate cancer etiology

    Time frame: 4 years

    molecular analysis of genomic DNA

Secondary outcomes

  1. Presence/absence and type of variants in genes potentially implicated in the etiology of prostate cancer (candidate genes).

    Time frame: 4 years

    molecular analysis of genomic DNA

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: ProK55

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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