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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT03920033
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed intermediate- or high-risk prostate cancer
* Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng/mL and \<=1.0 ng/mL)
* ECOG performance status 0-1
* Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl
* Appropriate values of kidney function within 6 months after enrollment Creatinine \< 2.0 ng/dL
* Appropriate values of liver function within 6 months after enrollment total bilirubin \< 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \< 2.5 X maximum normal value
Exclusion Criteria:
* Clinically gross recurrent tumor
* Presence of distant metastasis
* Presence of pelvic LN metastasis
* History of pelvic irradiation
* History of cryotherapy or brachytherapy for prostate cancer
* Double primary cancer other than skin/thyroid cancer
* Combined serious morbidity
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT03920033
Study Brief:
Protocol Section:
NCT03920033