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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT02723734
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with Karnofsky Performance Status \>70
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Pathologically (histologically) proven diagnosis of prostate cancer (PCa) undergoing their first line of treatment
* Meet National Comprehensive Cancer Network (NCCN) criteria for either: Low risk PCa (defined as Gleason score 6 in ≥ 3 cores; T-stage T1c- T2a); Intermediate risk PCa (defined as Gleason score 7, or prostatic specific antigen (PSA) ≥ 10 ng/ml \& \< 20 ng/ml, or T-stage ≤ T2c)
* Eligible for either radical prostatectomy (RP) or definitive radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT))
* Age \> 18 years
* Biopsy specimen available
Exclusion Criteria:
* Inability to acquire biopsy or prostatectomy tissue
* History of prior PCa directed chemotherapy or pelvic irradiation (prior to study enrollment)
* Documented distant metastatic disease or pelvic lymphadenopathy
* Prior radical prostatectomy (RP) or cryosurgery for prostate cancer or bilateral orchiectomy
* Targeted for active surveillance after diagnostic biopsy
* Selecting ADT alone after diagnostic biopsy
* On active surveillance for \> 6 months after diagnosis
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02723734
Study Brief:
Protocol Section:
NCT02723734