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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT00882232
Eligibility Criteria:
Inclusion Criteria:
1. Histologically-confirmed adenocarcinoma of the prostate, clinical stage T1c-T2c, NX, N0, M0.
2. Nodes determined to be negative by imaging methods will be classified as NX. Only nodes determined to be negative by surgical sampling will be classified as N0.
3. Prostate cancer biopsy grading by Gleason score classification is mandatory.
4. No prior pelvic radiotherapy. Induction hormonal therapy for less than or equal to 6 months is acceptable.
5. Prostate volume by TRUS \< 50 cc prior to HDR brachytherapy.
6. Prostate specific antigen (PSA) less than or equal to 30 ng/ml.
7. Patient has provided informed consent.
Exclusion Criteria:
1. Clinical stage T3 or T4.
2. Clinical evidence of lymph node involvement (N1).
3. Clinical evidence of distant metastases (M1).
4. Radical surgery for carcinoma of the prostate.
5. Allergy to avian products.
6. Significant mental, medical, or physical impairment.
7. Prisoners.
8. Employees of the Cancer Center of Irvine.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00882232
Study Brief:
Protocol Section:
NCT00882232