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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03424694
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven prostate adenocarcinoma
* Clinical Stage T1c - T2c
* Gleason Score between 6 and 7
* PSA \< 15 ng / ml
* Prostate volume \< 70 cc as determined by ultrasound or IRM
* Signed informer consent
* Clinical conditions for complete diagnosis checkup and treatment procedure
* Should be able to complete IIEFS,IPSS and QLQ-C30 questionnaires
* Bone and pelvic scan negative for metastasis
Exclusion Criteria:
* Prior pelvis radiation
* Prior Transurethral resection of the prostate (TURP) (less than 6 months)
* International Prostate Symptom Score: IPSS \> 16
* Contraindication to radiotherapy
* No prior use of Androgen deprivation therapy (ADT)
* Observation: 5 alpha-reductase (5AR) inhibitors is authorized.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03424694
Study Brief:
Protocol Section:
NCT03424694