Prostate Cancer Clinical Trial
Official title:
MRI-targeted Biopsy of the Prostate: a Prospective Comparison of Software-based Fusion Versus Visual (Cognitive) Registration in the Accuracy of Clinically Significant Prostate Cancer Detection
With the general acceptance of MRI and technical advances in biopsy technique of the prostate, new questions arise concerning the selection of patients, the approach, the appropriate technique, the lesions to target and the number of biopsies. The purpose of this study is to address these issues in men suspicious of having prostate cancer and without prior biopsies.
Trial Design: This is a prospective, single center, comparative, diagnostic study of two
biopsy techniques. All men aged 50 to 75 years with clinical suspicion of PCa (elevated
prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination)
and an MRI with suspicious lesion(s) (presence of PI-RADS 3-5 lesion) will be included.
Participants receive both types of biopsy, but will be randomized concerning the order of the
biopsy. All men will also receive traditional systematic biopsies. Treatment and further
follow-up is according to EAU guidelines. Data of treatment and follow-up will be retrieved
till 2 years after initial MRI-visit.
Sample Size: Based on McNemar test for the comparison between the accuracy of the two biopsy
techniques, the required sample size is estimated on 96 patients.
Assessment of efficacy: Efficacy of software and visual registration biopsy will be
determined by histopathology: cancer core length (actual length and percentage) and
comparison with systematic biopsy as reference standard.
Direct access to source data and documents: The investigator(s) and the institution(s) will
permit trial-related monitoring, audits, EC review, and regulatory inspections (where
appropriate) by providing direct access to source data and other documents (i.e. patients'
case sheets, blood test reports, X-ray reports, histology reports, etc.).
Data handling and management: All data collected during the study remain confidential and
according to the GDPR regulation. Data of the participants will be retrieved from their
electronic patient files. Each participant will be given a unique identification number. When
data are coded, there continues to be a link between the data and the individual who provided
it. The research team is obligated to protect the data from disclosure outside the research
according to the terms of the research protocol and the informed consent document. The
subject's name or other identifiers should be stored separately (site file) from their
research data and replaced with a unique code to create a new identity for the subject. Note
that coded data are not anonymous. All data is collected and stored electronically by the
principal investigator and co-investigators.
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