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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT04045756
Eligibility Criteria:
Inclusion Criteria:
* Male
* Over 45 years old
* Prostate cancer identified after prostatic biopsy with fusion of images with target and systematic samples (\> 12)
* Intermediate progression risk (Gleason Score 3 + 4 or 4 + 3; PSA \<15 ng / ml; clinical stage T1-T2a)
* Low risk of progression (Gleason score 3 + 3) only in patients who wish to leave or who refuse the active surveillance protocol and who refuse validated treatments for the treatment of organo-confined prostate cancer: radical surgery and / or radiotherapy
Exclusion Criteria:
* Prostate cancer Gleason Score\> = 4 + 4.
* Clinical stage\> T2a
* PSA\> 15 ng / ml
* Presence of metastases from prostate lymph node, bone or visceral carcinoma detected by bone scintigraphy, total body CT or PET-CT
* Serious coagulation disorders not correctable
* Unavailable or replaceable anticoagulant and / or antiplatelet therapy
* Inadequate compliance
* Presence of pacemakers
* Contraindications to MRI (claustrophobia, ear implants, metal prostheses)
* Paramagnetic contrast agent allergy
* Acute and / or chronic renal failure (GFR \<50 mL / min and serum creatinine\> 1.5 mg / dl)
* Tumor volume \<15 ml measured on MRI
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
46 Years
Maximum Age:
86 Years
Study:
NCT04045756
Study Brief:
Protocol Section:
NCT04045756