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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04021394
Eligibility Criteria:
Inclusion Criteria (all patients):
* histologically diagnosed prostate cancer
* signed informed consent
HR-HSPC cohort
* previous prostatectomy
* previous treatment with androgen deprivation therapy for \<90 days and/or recommended but not yet started new line of androgen deprivation therapy
* adverse pathological findings (\>=1 of extracapsular extension, positive margins, and/or seminal vesicle invasion)
* documented evidence of biochemical failure following adjuvant/salvage radiation therapy
* PSA of \>1 ng/ml
LV-mHSPC cohort
* previous treatment with androgen deprivation therapy for \<90 days and/or recommended but not yet started new line of androgen deprivation therapy
* documented evidence of metastatic disease (bone only; less than 4 lesions contained within the vertebral column or pelvis)
HV-mHSPC cohort
* previous treatment with androgen deprivation therapy for \<90 days and/or recommended but not yet started new line of androgen deprivation therapy
* documented evidence of "high volume" metastatic disease (visceral metastases \[extranodal\] and/or bone metastases \[\>=4 bone lesions with \>=1 lesion outside the vertebral column or pelvis\])
mCRPC cohort
* documented evidence of progression while receiving androgen ablation therapy (medical or surgical castration) according to PCWG2 criteria
* documented evidence of metastatic disease (bone or visceral)
Exclusion Criteria:
* patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer (all cohorts)
* documented evidence of metastatic disease (HR-HSPC cohort)
* documented evidence of castrate-resistance (all HSPC cohorts)
* currently on active androgen deprivation therapy (all HSPC cohorts)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04021394
Study Brief:
Protocol Section:
NCT04021394