Genetics of Prostate Cancer in Young Patients (ProK55)
November 28, 2024 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bologna, Italy, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population will consist of patients aged 18 years or older with a diagnosis of prostate cancer and age ≤55 years at first diagnosis.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients diagnosed with prostate carcinoma before the age of 55
Exome sequencing (WES) of genomic DNA
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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4 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cesare Rossi, Biologist, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2023
Primary Completion (Actual)
June 11, 2024
Study Completion (Actual)
September 30, 2024
Study Registration Dates
First Submitted
November 28, 2024
First Submitted That Met QC Criteria
November 28, 2024
First Posted (Actual)
December 3, 2024
Study Record Updates
Last Update Posted (Actual)
December 3, 2024
Last Update Submitted That Met QC Criteria
November 28, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ProK55
- RC 2022-2024 (Other Grant/Funding Number: Ministero della Salute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD not included in the protocol approved by the ethics committee
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.