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

Prostate Cancer Clinical Trial

— PROSOVI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03819751
• Other study ID #: s.nr
• Status: Recruiting
• Phase: N/A
• 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
• 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:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: July 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Neoplasm
• Prostatic Neoplasms

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)

Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20. — View Citation

Fütterer JJ, Briganti A, De Visschere P, Emberton M, Giannarini G, Kirkham A, Taneja SS, Thoeny H, Villeirs G, Villers A. Can Clinically Significant Prostate Cancer Be Detected with Multiparametric Magnetic Resonance Imaging? A Systematic Review of the Literature. Eur Urol. 2015 Dec;68(6):1045-53. doi: 10.1016/j.eururo.2015.01.013. Epub 2015 Feb 2. Review. — View Citation

Kasivisvanathan V, Emberton M, Moore CM. MRI-Targeted Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 Aug 9;379(6):589-590. doi: 10.1056/NEJMc1807507. — View Citation

Logan JK, Rais-Bahrami S, Turkbey B, Gomella A, Amalou H, Choyke PL, Wood BJ, Pinto PA. Current status of magnetic resonance imaging (MRI) and ultrasonography fusion software platforms for guidance of prostate biopsies. BJU Int. 2014 Nov;114(5):641-52. doi: 10.1111/bju.12593. Epub 2014 May 22. Review. — View Citation

Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Fütterer JJ, Gill IS, Grubb Iii RL, Hadaschik B, Klotz L, Margolis DJ, Marks LS, Melamed J, Oto A, Palmer SL, Pinto P, Puech P, Punwani S, Rosenkrantz AB, Schoots IG, Simon R, Taneja SS, Turkbey B, Ukimura O, van der Meulen J, Villers A, Watanabe Y; START Consortium. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an International Working Group. Eur Urol. 2013 Oct;64(4):544-52. doi: 10.1016/j.eururo.2013.03.030. Epub 2013 Mar 20. — View Citation

Moore CM, Robertson NL, Arsanious N, Middleton T, Villers A, Klotz L, Taneja SS, Emberton M. Image-guided prostate biopsy using magnetic resonance imaging-derived targets: a systematic review. Eur Urol. 2013 Jan;63(1):125-40. doi: 10.1016/j.eururo.2012.06.004. Epub 2012 Jun 13. Review. — View Citation

Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouvière O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25. — View Citation

Puech P, Rouvière O, Renard-Penna R, Villers A, Devos P, Colombel M, Bitker MO, Leroy X, Mège-Lechevallier F, Comperat E, Ouzzane A, Lemaitre L. Prostate cancer diagnosis: multiparametric MR-targeted biopsy with cognitive and transrectal US-MR fusion guidance versus systematic biopsy--prospective multicenter study. Radiology. 2013 Aug;268(2):461-9. doi: 10.1148/radiol.13121501. Epub 2013 Apr 11. — View Citation

Wysock JS, Rosenkrantz AB, Huang WC, Stifelman MD, Lepor H, Deng FM, Melamed J, Taneja SS. A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial. Eur Urol. 2014 Aug;66(2):343-51. doi: 10.1016/j.eururo.2013.10.048. Epub 2013 Nov 8. — View Citation

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