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

• ClinicalTrials.gov Identifier: NCT03693703
• Recruitment Status: Completed
• First Posted: October 3, 2018
• Last Update Posted: August 12, 2020
• Sponsor: Fondazione del Piemonte per l'Oncologia
• Information provided by (Responsible Party): Fondazione del Piemonte per l'Oncologia

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Prostatic Neoplasm	Diagnostic Test: bi-parametric MRI; Diagnostic Test: multi-parametric MRI	Not Applicable

Detailed Description:

The trial is a prospective, randomized, two-arms study with a 2:1 ratio. Subjects meeting the inclusion criteria will be randomized either into the bp-MRI group (arm A), or the mp-MRI one (arm B). All subjects will perform blood sampling in EDTA tubes before undergoing imaging session. Plasma will be isolated within 1 hour from sampling, with a double round centrifugation, aliquoted and stored at -80°C before undergoing miR analysis.

MRI will be performed with a 1.5 T using axial T2w and diffusion-weighted imaging for subjects in arm A with no endorectal coil and no intravenous contrast agent. Men randomized in arm B will undergo MRI with T2w in the three acquisition planes, diffusion-weighted and dynamic contrast-enhanced imaging usign endorectal coil.

Random biopsy will be performed in subjects with no suspicious regions for PCa found on MRI. Men with suspicious regions on MRI will be invited to a targeted or in-bore biopsy.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 391 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Cost-efficacy of a Preliminary Diagnostic Program Using Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer and no Previous Prostate Biopsy: a Prospective Randomized Clinical Study Comparing Multiparametric and Bi-parametric Magnetic Resonance Imaging Results
• Actual Study Start Date: April 18, 2018
• Actual Primary Completion Date: March 31, 2020
• Actual Study Completion Date: March 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: bi-parametric MRI; Patients will undergo axial T2-weighted and diffusion-weighted imaging (no contrast agent injection)	Diagnostic Test: bi-parametric MRI; Axial T2-weighted and diffusion-weighted imaging with no endorectal coil nor intravenous contrast agent administration
Active Comparator: multi-parametric MRI; 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; T2-weighted imaging in the three planes, diffusion-weighted and dynamic contrast-enhanced imaging using endorectal coil and intravenous contrast agent administration

Outcome Measures

Primary Outcome Measures :

1. Detection rate of bi-parametric MRI, and of mp-MRI in men at risk for PCa and with no previous prostate biopsy [ Time Frame: 3 months ]
   Sensitivity, specificity, PPV and NPV will be measured

Secondary Outcome Measures :

1. Dimension of lesions identified at bp-MRI/mp-MRI; [ Time Frame: 2 weeks ]
   Mean lesion dimension will be assessed in each study arm
2. The proportion of clinically significant PCa identified at bp-MRI; [ Time Frame: 2 weeks ]
   The number of clinically significant PCa over the total number of PCa detected at bp-MRI will be measured
3. Positive predictive value of miR test alone and in combination with PSA blood test in identifying histologically confirmed PCa patients [ Time Frame: 3 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

Italy

Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute

Candiolo, Turin, Italy, 10060

Sponsors and Collaborators

Fondazione del Piemonte per l'Oncologia

Investigators

• Principal Investigator: Filippo Russo, MD; Fondazione del Piemonte per l'Oncologia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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-naïve Men. Eur Urol Oncol. 2021 Dec;4(6):855-862. doi: 10.1016/j.euo.2021.03.007. Epub 2021 Apr 21.

• Responsible Party: Fondazione del Piemonte per l'Oncologia
• ClinicalTrials.gov Identifier: NCT03693703
• Other Study ID Numbers: bpMRscr16
• First Posted: October 3, 2018
• Last Update Posted: August 12, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondazione del Piemonte per l'Oncologia:

magnetic resonance imaging; prostate biopsy; microRNA

Additional relevant MeSH terms:

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