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Trial Title:
Prostate Cancer Screening: a Pilot Study
NCT ID:
NCT06238661
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
PSA
Risk Calculator
Magnetic Resonance Imaging
Prostate biopsy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Urology visit with Risk Calculator and MRI
Description:
Patients with PSA ≥3 ng/ml will undergo urology visit with risk calculator and MRI
assessment of the prostate
Arm group label:
Subjects with PSA ≥ 3 ng/ml
Summary:
Prostate Cancer (PCa) is the second most frequently diagnosed tumour and the third most
lethal among men in Europe. The lack of precise tools and examinations to precisely
diagnose PCa has caused overtreatment of indolent and low-aggressive PCa, while in some
other cases, with aggressive disease, diagnosis and treatment are dangerously delayed
because cancer could be potentially missed. The present trial aims to study a new pathway
to early diagnose PCa with Magnetic Resonance Imaging (MRI) to identify men who will not
need treatment and those who will benefit from radical treatment, thus improving disease
control and quality of life.
Detailed description:
Men aged 55-65 years with neither previous biopsy nor prostate diseases will be invited
in the screening protocol and will perform an initial PSA test. Those cases with PSA ≥ 3
ng/ml will be invited to undergo a urologic examination with computed risk assessment and
an MRI, which is a non-invasive test with high positive and negative predictive value in
identifying clinically significant prostate cancer. Then, only men with medium-high risk
of harbouring clinically significant prostate cancer will be invited to undergo a
prostate biopsy to indentify cancer presence and its aggressiveness.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- age between 55-65 years;
- asymptomatic or paucisymptomatic from a urological point of view;
- no previous prostate biopsy;
- living in the ASL TO5 (Piedmont, Italy);
- signed written informed consent.
Exclusion Criteria:
- positive oncologic anamnesis for prostate cancer;
- previous biopsy or prostate surgery;
- previous radiotherapy of the pelvis;
- any contraindication to MRI examination;
- claustrophobic or uncollaborative subjects.
Gender:
Male
Gender based:
Yes
Minimum age:
55 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione del Piemonte per l'Oncologia
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Contact:
Last name:
Daniele Regge, MD
Phone:
+390119933021
Email:
daniele.regge@ircc.it
Start date:
May 1, 2024
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Fondazione del Piemonte per l'Oncologia
Agency class:
Other
Collaborator:
Agency:
San Luigi Gonzaga Hospital
Agency class:
Other
Collaborator:
Agency:
Epidemiology and Screening Unit - CPO, Turin, Italy
Agency class:
Other
Source:
Fondazione del Piemonte per l'Oncologia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06238661
