All-in-One Prostate Cancer Staging With MRI (AllinOne_MRI)

October 11, 2023 updated by: European Institute of Oncology
Prior to treatment, it is essential to assess not only the extent of prostate cancer within the prostate, but also to determine whether the disease has initiated metastatic spread. Whole-body MRI has become a viable option for the detection of metastatic disease derived from a number of cancers, but is typically performed in a separate scanning session to an initial dedicated prostate MRI in which the local disease is assessed. In patients known to be at high risk for significant prostate cancer prior to this initial MRI, and thus highly likely to proceed to treatment, this delays arriving at a definitive treatment decision. The investigators will evaluate the sensitivity of a protocol that combines bi-parametric prostate MRI, performed according to PI-RADS v2.1 guidelines, with a whole-body MRI based on the METastasis Reporting and Data System for Prostate Cancer (MET-RADS-P) guidelines, for an All-in-One, local and systemic staging of intermediate-favorable or high risk prostate cancer patients. The resulting staging decisions will be compared to the results of systemic staging with those obtained by computed tomography and bone scintigraphy in the standard staging pathway.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Accurate tumor staging for unfavorable intermediate- and high-risk prostate cancer patients should underpin both prognostication and management decisions. This void necessitates evaluation of the local, primary disease as well as spread to distant sites including lymph nodes and possible distant metastases.

Multi-parametric magnetic resonance imaging (mp-MRI) has become the reference standard practice for local imaging-based assessment in prostate cancer (PCa). Whole-body MRI (WB-MRI) is seeing growing for detection of distant, metastatic disease, and is particularly suited to detection of bone metastases, which are common in PCa. The possibility of a one-stop staging modality has been raised, wherein mp-MRI + whole body MRI (WB-MRI) would be used to further assess nodal and metastatic disease status in a single sitting. Currently however, international guidelines consider bone scintigraphy (BS) and pelvic computed tomography (CT) for distant disease to be the mainstays of imaging-based staging decisions. A further concern with transitioning to All-in-One prostate staging with MRI relates to the duration of scanning required, as an excessive scan duration is likely to lead to patient discomfort, motion and consequently reduce image quality.

The prostate imaging reporting and data system (PI-RADS) v2.1 standard published by Turkbey et al. provides guidelines for mp-MRI of the prostate that are widely used as the basis for assessment of local, primary PCa. Recent evidence suggests that some components of the PI-RADS mp-MRI protocol are of little or no benefit to men with a very high risk of aggressive PCa, defined as prostate specific antigen (PSA) ≥10 ng/mL and + digital rectal exam, even before initial biopsy or repeated biopsy. In particular, dynamic contrast enhanced (DCE) imaging and T2-weighted images (T2WI) in a third orthogonal plane does not improve the overall accuracy of mp-MRI. Therefore, biparametric MRI (bp-MRI; i.e. T2WI in two planes, diffusion-weighted imaging (DWI, without contrast agent injection)) has been suggested to reduce examination time and cost, while retaining sufficient diagnostic accuracy to "rule out" high-grade PCa in biopsy-naïve men.

WB-MRI offers greater sensitivity and diagnostic accuracy for bone and nodal disease than BS and conventional CT. Further, a meta-analysis by Woo et al. has shown MRI (DWI + conventional sequences) to have excellent sensitivity and specificity in particular for detection of bone metastases in patients with PCa. The pooled per-patient sensitivity and specificity of MRI in the 10 studies included in the meta-analysis were 0.96 (95% confidence interval (CI) 0.87-0.99) and 0.98 (95% CI 0.93-0.99), respectively. Similar performance for WB-MRI is reported in the meta-analysis of Shen et al. who found the diagnostic performance of WB-MRI to be similar to that of choline PET/CT, with both being superior to BS in the detection of bone metastases. The pooled sensitivities and specificities in this meta-analysis were 0.97/0.95 and 0.79/0.82 for WB-MRI and BS respectively. WB-MRI appears to be more accurate than conventional CT, which not surprising the pooled sensitivities and specificities of CT alone have been reported as 0.42 and 0.82 in a pair of meta-analyses . A recent work by Johnston et al., found that a WB-MRI protocol consisting of unenhanced T1-weighted DIXON and diffusion-weighted scans provides much higher diagnostic accuracy than BS (sensitivity/specificity 0.90/0.88 vs 0.60/1.00) for the primary staging of intermediate- and high-risk PCa. They also found high and very similar sensitivities/specificities for WB-MRI and BS in respect to nodal disease, with values of 1.00/0.96 and 1.00/0.82 for N1 disease and 0.75/ 0.93 and 0.75/0.92 for M1a disease respectively.

The investigators are continuing their studies into the role and the added value of WB-MRI in oncologic patients with advanced cancer (prostate, breast, melanoma], lymphoma).

The investigators propose to evaluate the sensitivity of a protocol that combines bp-MRI of the prostate, following the PI-RADS v2.1 guideline, with WB-MRI based on MET-RADS-P guidelines, for an All-in-One, local and systemic staging of unfavorable intermediate- and high-risk prostate cancer patients and to compare the results of systemic staging with those obtained with CT and BS in the standard staging pathway. The combination of bp-MRI and WB-MRI is expected to require a scan time of roughly 40 minutes, allowing it to be performed in a conventional mp-MRI scan time allotment.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • BS
      • Brescia, BS, Italy, 25123
    • MI
      • Milano, MI, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giuseppe Petralia, MD
    • VR
      • Verona, VR, Italy, 37134
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Integrata di Verona, Ospedale Borgo Roma
        • Contact:
        • Principal Investigator:
          • Mirko Onofrio, MD
        • Principal Investigator:
          • Nicolò Cardobi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

unfavorable intermediate- and high-risk prostate cancer patients

Description

Inclusion Criteria:

  • at least one of: International Society of Urological Pathology Grade Group ≥ 3 (Gleason Score ≥ 4+3); cT3 initial diagnosis with any PSA level; PSA ≥ 20 ng/mL with any Gleason score;
  • and all the following: Signed informed consent; Patients eligible to active treatment (either radical prostatectomy or radiotherapy) and/or hormone therapy; Life expectancy ≥ 10 years;

Exclusion Criteria:

  • Contraindications to MRI (e.g. severe claustrophobia or MRI unsafe device);
  • Previous or ongoing hormone therapy or radiation therapy for prostate cancer;
  • Significant intercurrent morbidity that, in the judgment of the investigator, would limit compliance with study protocols;
  • Previous mp-MRI performed within six weeks of the outpatient visit and compliant with PI-RADS v2.1 guidelines;
  • Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostate Cancer Patients

Patients will undergo a combined whole-body MRI + multiparametric prostate MRI examination along with routine staging examinations (PET, CT / bone scintigraphy).

Reporting will be performed without and with reference to the whole-body MRI examination. Differences in the resulting staging and in management recommendations based on the two reportings will be recorded.
Diagnostic test: Prostate Cancer Patients
see arm/group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staging Sensitivity
Time Frame: 1 year
Sensitivity (SE) of the evaluated diagnostic procedures based on the case report forms (CRFs) compiled at the time of reporting
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staging Specificity
Time Frame: 1 year
Specificity (SP) and the overall accuracy of the evaluated diagnostic procedures based on the CRFs compiled at the time of reporting
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Collaborators

Azienda Ospedaliera Universitaria Integrata Verona
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

  • Principal Investigator: Giuseppe Petralia, MD, European Institute of Oncology, IEO IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2021

Primary Completion (Estimated)

June 22, 2026

Study Completion (Estimated)

August 22, 2026

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 1537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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