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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT03225235
Eligibility Criteria:
Inclusion Criteria:
* men from 40 to 75 years of age with a confirmed adenocarcinoma prostate, prostate biopsy will be performed \<180 days prior to the randomization date,
* completed assessment of tumor differentiation according to Gleason grading allows to perform stratification;
* general Performance Status according to the Eastern Cooperative Oncology Group (ECOG) classification ( 0 -1),
* belonging to the group of low and intermedium risk of progression; (cT1-cT2c, Gleason 7, PSA to 19.9 ng / ml), cT specified by AJCC 7 Edition (appendix 2),
* PSA marked at least 10 days after or before the biopsy, and for patients taking phytosterol 30 days after discontinuation,
* no distant metastases,
* signing informed consent,
* morphological and biochemical blood parameters within the normal limits.
Exclusion Criteria:
* the presence of active cancer, except skin cancer preceding period 5 years prior to randomization,
* surgical treatment (radical prostatectomy) or RT in the pelvic area,
* co-morbidities that may significantly affect the expectancy life of the patients
* do not meet the criteria for inclusion.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03225235
Study Brief:
Protocol Section:
NCT03225235