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

NCT03819751 | Recruiting

• 1 other identifier: s.nr
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Neoplasm

Keywords

prostatic neoplasms; biopsy; Multimodal Imaging; prostate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Analysis of the performance of software versus visual registration biopsy in subgroups

  From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit

• Added value of systematic biopsies

  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

  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

  From MRI-visit till results of radical prostatectomy is known or till up to 2 years after MRI-visit

Study Arms (1)

MRI-targeted prostate biopsy

OTHER

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.

Procedure: MRI-targeted prostate biopsy

Interventions

MRI-targeted prostate biopsy PROCEDURE

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

Also known as: MRI/TRUS fusion biopsy with Philips Percunav

MRI-targeted prostate biopsy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Gender Eligibility Details: Participants need to have a prostate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-brabant, 3000, Belgium

RECRUITING

Related Publications (9)

• 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, Rouviere 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.

  PMID: 27568654 BACKGROUND

• Futterer 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.

  PMID: 25656808 BACKGROUND

• 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.

  PMID: 28110982 BACKGROUND

• 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. No abstract available.

  PMID: 30089067 BACKGROUND

• 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.

  PMID: 22743165 BACKGROUND

• 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.

  PMID: 24298917 BACKGROUND

• 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.

  PMID: 24262102 BACKGROUND

• Puech P, Rouviere O, Renard-Penna R, Villers A, Devos P, Colombel M, Bitker MO, Leroy X, Mege-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.

  PMID: 23579051 BACKGROUND

• Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Futterer 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.

  PMID: 23537686 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Cindy Mai, MD

  University Hospital Leuven, Department of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy Mai, MD

CONTACT

016345032; cindy.mai@uzleuven.be

Frederik De Keyzer

CONTACT

016347755; frederik.dekeyzer@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 28, 2019
• Study Start: March 18, 2019
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)