Clinical trial NCT06238661: Prostate Cancer Screening: a Pilot Study
Official title: Prostate Cancer Screening With PSA, Risk Calculator and Multiparametric MRI: a Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
PSA
Risk Calculator
Magnetic Resonance Imaging
Prostate biopsy
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
Collaborators: name: San Luigi Gonzaga Hospital
name: Epidemiology and Screening Unit - CPO, Turin, Italy
name: ASL TO5
First posted: 2024-02-02
Enrollment: 4500
Sex: MALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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.

Primary outcomes:
measure: Detection rate of clinically significant prostate cancer (Gleason Group ≥2)
timeFrame: 24 months
measure: Comparison of the detection rate of clinically significant prostate cancer with and without screening
timeFrame: 24 months
measure: Verify that the detection rate of clinically significant prostate cancer with the screening strategy is not inferior to that of the Italian cohort in the ERSPC study
timeFrame: 24 months
Secondary outcomes:
measure: Changes in number of biopsy procedures
timeFrame: 24 months
measure: Assessment of positive and negative predictive values
timeFrame: 24 months
Other outcomes:
Locations:
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia
Study officials:
affiliation: Fondazione del Piemonte per l'Oncologia
name: Daniele Regge, MD
role: PRINCIPAL_INVESTIGATOR
References: