MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection (PROSOVI)

June 14, 2019 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Unknown

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.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MRI-targeted prostate biopsy
Participants receive both type of MRI-targeted biopsy. Patients are randomized with one half having visual registration first and the other half having software registration first.
All participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy)
Other Names:
  • MRI/TRUS fusion biopsy with Philips Percunav

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the two MR-guided registration techniques (visual and software-based) in the detection of clinically significant prostate cancer
Time Frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Assessment of the detection rate of clinically significant prostate cancer of software registration biopsy and visual registration biopsy, using traditional TRUS-guided systematic biopsy, whole mount radical prostatectomy specimen and follow-up as reference.
From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the performance of software versus visual registration biopsy in subgroups
Time Frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit

Assessment of the performance of software registration biopsy and visual registration biopsy in the detection of clinically significant cancer in :

  • lesions in small volume prostates (<50 gram) versus large volume prostates (>50 gram).
  • transitional zone versus peripheral zone lesions
  • basal versus apical lesions
  • small (max. diameter < or = 10 mm) versus large lesions (max. diameter > 10 mm)
  • intermediate suspicious lesions (PI-RADS 3) versus highly suspicious lesions (PI-RADS 4-5).
From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Added value of systematic biopsies
Time Frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Assessment of the added value of systematic biopsies on top of MRI-targeted biopsy of PI-RADS 3, 4 and 5 lesions. Compare MRI-targeted + systematic biopsies versus MRI-targeted biopsies alone in T-staging and therapy options.
From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Discriminative features of PI-RADS 3 lesions on MRI
Time Frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Lesion diameters, shape, intensity on T2 and aspect, ADC-values on ADC-map will be measured to identify possible discriminative features of 'malignant' s "benigne" PI-RADS 3 lesions.
From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Features of prostate cancer differentiation grade on MRI
Time Frame: From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit
Measure ADC-value to differentiate prostate cancer differentiation grade.
From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cindy Mai, MD, University Hospital Leuven, Department of Radiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2019

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 25, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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