Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer

NCT03693703 | Completed

• 1 other identifier: bpMRscr16
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the detection rate of biparametric (bp) magnetic resonance imaging (MRI) for clinically significant prostate cancer (PCa) with that of multiparametric (mp)-MRI, in biopsy-naïve patients. Today, bp-MRI is not the standard diagnostic procedure, however preliminary studies showed its non-inferiority with respect to mp-MRI. Its implementation on a wide scale could significantly reduce examination costs (no iv contrast agent and no endorectal coil), and study time. Secondary objectives will be:

• to assess specificity of a blood test based on microRNA (miR) score in biopsy-naïve patients, using pathological assessment after MR-guided biopsy as reference standard. If specificity of the miR score is higher than that of PSA, then fewer patients will undergo unnecessary MRI, thus increasing the efficiency of the diagnostic pipeline for PCa;
• to develop a clinical decision support system (CDSS) based on MRI and circulating miR evaluation, to stratify patients according to their risk of PCa progression, using pathological assessment after prostatectomy as reference standard. Patients will be stratified into two classes of risk: i) low-risk PCa, in which patients may benefit from a conservative approach (i.e. active surveillance), and ii) medium/high-risk PCa in which patients should undergo radical treatment (i.e. surgery or radiation therapy).

Conditions

Prostatic Neoplasm

Keywords

magnetic resonance imaging; prostate biopsy; microRNA

Outcome Measures

Primary Outcomes (1)

• Detection rate of bi-parametric MRI, and of mp-MRI in men at risk for PCa and with no previous prostate biopsy

  Sensitivity, specificity, PPV and NPV will be measured

  3 months

Secondary Outcomes (3)

• Dimension of lesions identified at bp-MRI/mp-MRI;

  2 weeks

• The proportion of clinically significant PCa identified at bp-MRI;

  2 weeks

• Positive predictive value of miR test alone and in combination with PSA blood test in identifying histologically confirmed PCa patients

  3 months

Study Arms (2)

bi-parametric MRI

EXPERIMENTAL

Patients will undergo axial T2-weighted and diffusion-weighted imaging (no contrast agent injection)

Diagnostic Test: bi-parametric MRI

multi-parametric MRI

ACTIVE COMPARATOR

Patients will undergo multiparametric MRI including morphological study (T2- and T1-weighted imaging) and functional acquisitions (diffusion-weighted and dynamic contrast-enhanced imaging)

Diagnostic Test: multi-parametric MRI

Interventions

bi-parametric MRI DIAGNOSTIC_TEST

Axial T2-weighted and diffusion-weighted imaging with no endorectal coil nor intravenous contrast agent administration

bi-parametric MRI

multi-parametric MRI DIAGNOSTIC_TEST

T2-weighted imaging in the three planes, diffusion-weighted and dynamic contrast-enhanced imaging using endorectal coil and intravenous contrast agent administration

multi-parametric MRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \<= 75 years
• PSA \<= 15 ng/ml
• no previous prostate biopsy
• negative digital rectal examination
• signed infomed conset

You may not qualify if:

• known prostate cancer diagnosis
• previous prostate biopsy or surgery
• contraindication to MRI
• non-cooperative subjects

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute

Candiolo, Turin, 10060, Italy

Location

Related Publications (1)

• Russo F, Mazzetti S, Regge D, Ambrosini I, Giannini V, Manfredi M, De Luca S, Bollito E, Porpiglia F. Diagnostic Accuracy of Single-plane Biparametric and Multiparametric Magnetic Resonance Imaging in Prostate Cancer: A Randomized Noninferiority Trial in Biopsy-naive Men. Eur Urol Oncol. 2021 Dec;4(6):855-862. doi: 10.1016/j.euo.2021.03.007. Epub 2021 Apr 21.

  PMID: 33893066 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Filippo Russo, MD

  Fondazione del Piemonte per l'Oncologia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: April 18, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

IT (1)