Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03693703
Study type Interventional
Source Fondazione del Piemonte per l'Oncologia
Contact
Status Completed
Phase N/A
Start date April 18, 2018
Completion date March 31, 2020

See also
  Status Clinical Trial Phase
Completed NCT03982095 - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Recruiting NCT05667636 - Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP Phase 2
Terminated NCT01996696 - Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to Androgen Deprivation Therapy and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate Phase 2
Completed NCT01431391 - Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer Phase 2
Completed NCT03289130 - Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness
Recruiting NCT04462926 - Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed N/A
Completed NCT00001446 - A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer Phase 2
Completed NCT02729103 - Treatment Patterns in Metastatic Prostate Cancer N/A
Completed NCT00956228 - Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer Phase 1/Phase 2
Completed NCT00126854 - High Field Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Brachytherapy Implantation N/A
Completed NCT00247312 - Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial Phase 3
Completed NCT00174863 - Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer Phase 2
Terminated NCT04221828 - Trial of NanoPac Focal Therapy for Prostate Cancer Phase 2
Completed NCT00001266 - A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma Phase 2
Active, not recruiting NCT03935282 - Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors N/A
Completed NCT03693742 - MSG Use With 18F-DCFPyL PET/CT Imaging N/A
Recruiting NCT06236789 - Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
Completed NCT02966535 - The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial N/A
Completed NCT02977143 - Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery N/A
Completed NCT00252460 - CT/MRI Co-registration Prostate Cancer Phase 1