Prostate Cancer Screening: a Pilot Study

Prostate Cancer Clinical Trial

— ProScreenMRI  

Official title:

Prostate Cancer Screening With PSA, Risk Calculator and Multiparametric MRI: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06238661
• Other study ID #: ProScreenMRI
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: March 2024
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Daniele Regge, MD
• Phone: +390119933021
• Email: daniele.regge[@]ircc.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4500
• Est. completion date: July 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Urology 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

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l'Oncologia	Candiolo

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia	Epidemiology and Screening Unit - CPO, Turin, Italy, San Luigi Gonzaga Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of clinically significant prostate cancer (Gleason Group =2)	No. of detected clinically significant prostate cancer with Gleason Group = 2 over the total no. of men enrolled in the trial	24 months
Primary	Comparison of the detection rate of clinically significant prostate cancer with and without screening	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	24 months
Primary	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	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	24 months
Secondary	Changes in number of biopsy procedures	Estimation of the number of biopsy that could be avoided using the new screening strategy compared to the use of PSA only.	24 months
Secondary	Assessment of positive and negative predictive values	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	24 months