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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00525720
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b (AJCC 6th Edition), N0, M0. Lymph node evaluation by either CT or MRI.
2. Zubrod performance status 0-1.
3. Patient must be greater than or equal to 18 years of age.
4. Patients with intermediate risk prostate cancer as determined by one of the following combinations: Gleason \< 7, PSA 10-15; Gleason 7, PSA must be \< 10.
5. Prostate specific antigen (PSA) prior to study entry must be less than or equal to 15 ng/ml.
6. Hormone naive.
7. Prostate volumes by TRUS less than or equal to 60 cc.
8. AUA voiding symptom scores \</= 15 (alpha blockers allowed); this is completed by the patient.
9. Patients must sign a study-specific informed consent form prior to study entry.
Exclusion Criteria:
1. Stage \< T1c, T2c, T3 or T4 disease (AJCC 6th Edition).
2. Lymph node involvement (N1).
3. Evidence of distant metastases (M1).
4. Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior TURP, prior cryosurgery, TUNA, TUMT of the prostate.
5. Active prostatitis.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00525720
Study Brief:
Protocol Section:
NCT00525720