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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03819751
Other study ID # s.nr
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 18, 2019
Est. completion date July 2022

Study information

Verified date January 2019
Source Universitaire Ziekenhuizen Leuven
Contact Cindy Mai, MD
Phone 016345032
Email cindy.mai@uzleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
MRI-targeted prostate biopsy
All participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy)

Locations

Country Name City State
Belgium UZ Leuven Leuven Vlaams-brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (9)

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Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of the two MR-guided registration techniques (visual and software-based) in the detection of clinically significant prostate cancer 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 Analysis of the performance of software versus visual registration biopsy in subgroups 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
Secondary Added value of systematic biopsies 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
Secondary Discriminative features of PI-RADS 3 lesions on MRI 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
Secondary Features of prostate cancer differentiation grade on MRI 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
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