Prostate Cancer
Conditions
Keywords
Prostate Cancer, PSA, Risk Calculator, Magnetic Resonance Imaging, Prostate biopsy
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.
Interventions
DIAGNOSTIC_TESTUrology visit with Risk Calculator and MRI
Patients with PSA ≥3 ng/ml will undergo urology visit with risk calculator and MRI assessment of the prostate
Sponsors
Fondazione del Piemonte per l'Oncologia
San Luigi Gonzaga Hospital
Epidemiology and Screening Unit - CPO, Turin, Italy
ASL TO5
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
55 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of clinically significant prostate cancer (Gleason Group ≥2) | 24 months | No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial |
| Comparison of the detection rate of clinically significant prostate cancer with and without screening | 24 months | No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial compared to the same proportion of men calculated in the 2-year period before the introduction of the screening protocol |
| 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 | 24 months | No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial compared to the same proportion of men included in the Italian cohort of the ERSPC study screened using PSA only |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in number of biopsy procedures | 24 months | Estimation of the number of biopsy that could be avoided using the new screening strategy compared to the use of PSA only. |
| Assessment of positive and negative predictive values | 24 months | Definition of positive and negative predictive values of the proposed screening strategy and comparison with those obtained in the ERSPC screening study with PSA only |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORDaniele Regge, MD
Fondazione del Piemonte per l'Oncologia
Outcome results
None listed