Status:
RECRUITING
All-in-One Prostate Cancer Staging with MRI
Lead Sponsor:
European Institute of Oncology
Collaborating Sponsors:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Azienda Ospedaliera Universitaria Integrata Verona
Conditions:
Prostate Cancer
Eligibility:
MALE
35+ years
Brief 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 ...
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 loca...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
December 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 22 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06071195
Start Date
December 22 2021
End Date
August 22 2026
Last Update
September 27 2024
Active Locations (3)
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1
Spedali Civili di Brescia
Brescia, BS, Italy, 25123
2
Istituto Europeo di Oncologia
Milan, MI, Italy, 20141
3
Azienda Ospedaliera Universitaria Integrata di Verona, Ospedale Borgo Roma
Verona, VR, Italy, 37134