Clinical trial NCT03819751: MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Prostate Neoplasm
Keywords: prostatic neoplasms
biopsy
Multimodal Imaging
prostate
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 96
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients receive both types of biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* willing to participate in the study by giving written informed consent.
* male subjects aged between 50 to 75 years.
* with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE).
* good health condition based on medical history, physical examination and vital sign measurements.
* with target lesion on dedicated MRI of the prostate (PI-RADS 3 to 5).

Exclusion Criteria:

* has a prior history of prostate cancer.
* had prior prostate biopsy.
* has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).
* has evidence of lymph nodes involvement on prostate MRI or abdominal CT
* has evidence of bone metastasis on bone scan.
* has a prior history of hip prosthesis, pelvic radiation therapy or androgen deprivation therapy
* unable to perform transrectal ultrasound due to prior rectal surgery or active rectal diseases (rectitis, ...)
* has any condition, physical, mental, familial or sociological, that could impede compliance with the study protocol and further follow-up. This is not an absolute contra-indication, but should be discussed with patient prior to registration in the trial.

Primary outcomes:
measure: Accuracy of the two MR-guided registration techniques (visual and software-based) in the detection of clinically significant prostate cancer
timeFrame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Secondary outcomes:
measure: Analysis of the performance of software versus visual registration biopsy in subgroups
timeFrame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
measure: Added value of systematic biopsies
timeFrame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
measure: Discriminative features of PI-RADS 3 lesions on MRI
timeFrame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
measure: Features of prostate cancer differentiation grade on MRI
timeFrame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-brabant
Study officials:
affiliation: University Hospital Leuven, Department of Radiology
name: Cindy Mai, MD
role: PRINCIPAL_INVESTIGATOR
References:
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