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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT00121212
Eligibility Criteria:
Inclusion Criteria
* Newly diagnosed prostate cancer
* Has completed conventional staging examinations, including biopsy with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy AND conventional staging examinations negative
* Candidate for curative radical prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery
* Deemed to be at medium or high risk for recurrence after initial curative treatment, as defined by 1 of the following criteria:
* Gleason score 7 AND prostate-specific antigen (PSA) 10-20 ng/mL
* Gleason score ≥ 8 AND PSA \< 10 ng/mL
* Gleason score ≥ 8 AND PSA \> 10 ng/mL
* Any Gleason score AND PSA \> 20 ng/mL
Exclusion Therapy:
* Not a candidate for treatment by surgery or radiation therapy with curative intent
* Inability to give informed consent
* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00121212
Study Brief:
Protocol Section:
NCT00121212