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NCT Number: NCT03693703

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

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).

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute

Candiolo, Turin, 10060, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bi-parametric MRI

Diagnostic Test

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

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

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

    Time frame: 3 months

    Sensitivity, specificity, PPV and NPV will be measured

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 3, 2018
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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