Status:
UNKNOWN
Prostate Cancer Secondary Screening in Sapienza and Policlinico Umberto I
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Prostate Cancer (Diagnosis)
Eligibility:
MALE
40-69 years
Phase:
NA
Brief Summary
Prostate Cancer (PCa) screening is still a controversial topic in the urology community, this is mostly linked to the low specificity of Prostate Specific Antigen (PSA) value. Screening with total PSA...
Detailed Description
ENDPOINTS Primary endpoint To investigate the role of non-contrast Magnetic Resonance Imaging (MRI), as a secondary prevention test for the early diagnosis of prostate cancer (PCa), comparing it with ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Males aged between 49-69 years (from the age of 40 for those with family history of prostate cancer) at the time of enrollment
- Life expectancy greater than or equal to 10 years
- Sufficient understanding of the Italian language for written and verbal understanding of the information for enrollment in the Trial and for the process of obtaining informed consent.
- Patient with the ability to understand and want, able to express informed consent and to perform all the visits and procedures required by the study
- Exclusion criteria:
- General contraindications to MRI
- Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer
- Any contraindications to prostate biopsy, such as severe coagulation abnormalities (INR\> 1.5), active urinary tract infection and acute prostatitis (NIH category I, II and III).
- Dementia or altered mental status that would prohibit understanding or granting informed consent
Exclusion
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
710 Patients enrolled
Trial Details
Trial ID
NCT04803188
Start Date
September 21 2020
End Date
September 1 2022
Last Update
March 17 2021
Active Locations (1)
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1
Sapienza University of Rome
Rome, Roma, Italy, 00185