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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT03819751
Eligibility Criteria:
Inclusion Criteria:
* willing to participate in the study by giving written informed consent.
* male subjects aged between 50 to 75 years.
* with a clinical suspicion of PCa: elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination (DRE).
* good health condition based on medical history, physical examination and vital sign measurements.
* with target lesion on dedicated MRI of the prostate (PI-RADS 3 to 5).
Exclusion Criteria:
* has a prior history of prostate cancer.
* had prior prostate biopsy.
* has a contra-indication for MRI (claustrophobia, non-compatible metallic implants).
* has evidence of lymph nodes involvement on prostate MRI or abdominal CT
* has evidence of bone metastasis on bone scan.
* has a prior history of hip prosthesis, pelvic radiation therapy or androgen deprivation therapy
* unable to perform transrectal ultrasound due to prior rectal surgery or active rectal diseases (rectitis, …)
* has any condition, physical, mental, familial or sociological, that could impede compliance with the study protocol and further follow-up. This is not an absolute contra-indication, but should be discussed with patient prior to registration in the trial.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT03819751
Study Brief:
Protocol Section:
NCT03819751