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:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03996005
Eligibility Criteria:
Inclusion Criteria:
* Male patient ≥ 50 years old
* Histologically confirmed adenocarcinoma of the prostate
* Gleason ≤ 7 (3 + 4) ; Grade group ≤ 2 according to Epstein
* Clinically \<T3, N0, M0
* PSA \< 15 ng/mL
* Prostate volume \<100g
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Life expectancy higher than 12 months in the judgement of the investigator
* Radiological TNM (prostate MRI) T ≤ 2 (absence of extra-capsular extension, absence of seminal vesicle invasion), N = 0, M = 0
* First line of treatment or relapse after initial radiotherapy
* Willing to give signed, informed consent freely
* Able to adhere to the follow-up schedule and other protocol requirements.
Exclusion Criteria:
* Contraindication to MRI
* Contraindication to general anesthesia
* Presence or history of any other malignancy except for non-melanoma skin cancer adequately treated at least 2 years before study entry
* Unreversible haemostasis disorder
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
80 Years
Study:
NCT03996005
Study Brief:
Protocol Section:
NCT03996005