Trial Title:
All-in-One Prostate Cancer Staging with MRI
NCT ID:
NCT06071195
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
Staging
Whole-Body Magnetic Resonance Imaging
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Prostate Cancer Patients
Description:
see arm/group description
Arm group label:
Prostate Cancer Patients
Summary:
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.
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.
Criteria for eligibility:
Study pop:
unfavorable intermediate- and high-risk prostate cancer patients
Sampling method:
Probability Sample
Criteria:
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;
Gender:
Male
Minimum age:
35 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Spedali Civili di Brescia
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luigi Grazioli, MD
Email:
luigi.grazioli@asst-spedalicivili.it
Contact backup:
Last name:
Luigi Grazioli, MD
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Petralia, MD
Phone:
+39 02 9437 2901
Email:
giuseppe.petralia@ieo.it
Contact backup:
Last name:
Paul Summers, PhD
Email:
paul.summers@ieo.it
Contact backup:
Last name:
Giuseppe Petralia, MD
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata di Verona, Ospedale Borgo Roma
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Nicolò Cardobi, MD
Email:
nicolo.cardobi@gmail.com
Contact backup:
Last name:
Mirko Onofrio, MD
Contact backup:
Last name:
Nicolò Cardobi, MD
Start date:
December 22, 2021
Completion date:
August 22, 2026
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Collaborator:
Agency:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliera Universitaria Integrata Verona
Agency class:
Other
Source:
European Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06071195
