Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT06071195
Eligibility 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;
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
35 Years
Study:
NCT06071195
Study Brief:
Protocol Section:
NCT06071195