Actively Recruiting
All-in-One Prostate Cancer Staging with MRI
Led by European Institute of Oncology · Updated on 2024-09-27
400
Participants Needed
3
Research Sites
243 weeks
Total Duration
On this page
Sponsors
E
European Institute of Oncology
Lead Sponsor
A
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
All-in-One Prostate Cancer Staging with MRI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one of the following: International Society of Urological Pathology Grade Group 63; 3 (Gleason Score 63; 4+3); clinical stage T3 at initial diagnosis with any PSA level; PSA 63; 20 ng/mL with any Gleason score
- Signed informed consent
- Eligible for active treatment such as radical prostatectomy, radiotherapy, and/or hormone therapy
- Life expectancy of 10 years or more
You will not qualify if you...
- Contraindications to MRI, such as severe claustrophobia or unsafe MRI devices
- Previous or ongoing hormone therapy or radiation therapy for prostate cancer
- Significant other medical conditions that may limit study compliance
- Multi-parametric MRI performed within six weeks prior to outpatient visit that follows PI-RADS v2.1 guidelines
- Prostate cancer with significant sarcomatoid, spindle cell, or neuroendocrine small cell components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Spedali Civili di Brescia
Brescia, BS, Italy, 25123
Actively Recruiting
2
Istituto Europeo di Oncologia
Milan, MI, Italy, 20141
Actively Recruiting
3
Azienda Ospedaliera Universitaria Integrata di Verona, Ospedale Borgo Roma
Verona, VR, Italy, 37134
Not Yet Recruiting
Research Team
G
Giuseppe Petralia, MD
CONTACT
P
Paul Summers, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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