All-in-One Prostate Cancer Staging with MRI

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 35
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Italy
Spedali Civili di Brescia
RECRUITING
Brescia
Istituto Europeo di Oncologia
RECRUITING
Milan
Azienda Ospedaliera Universitaria Integrata di Verona, Ospedale Borgo Roma
NOT_YET_RECRUITING
Verona
Contact Information
Primary
Giuseppe Petralia, MD
giuseppe.petralia@ieo.it
+39 02 94372901
Backup
Paul Summers, PhD
paul.summers@ieo.it
Time Frame
Start Date: 2021-12-22
Estimated Completion Date: 2026-08-22
Participants
Target number of participants: 400
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Azienda Ospedaliera Universitaria Integrata Verona, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov