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 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT00899912
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed, locally confined adenocarcinoma of the prostate
* Zubrod performance 0-1
* Clinical stages T1c - T2b, N0, M0
* Combined Gleason score 7 if prostate specific antigen (PSA) \< 10, combined Gleason score \< 7 if PSA 10 - 20; PSA must be ≤ 20 ng/mL, before hormone therapy, if given, and a prostate volume by transrectal ultrasound (TRUS) ≤ 60 cc.
* American Urological Association (AUA) score ≤ 15 (alpha blockers are allowed).
* Age ≥ 18 years old and must sign a study-specific informed consent form
Exclusion Criteria:
* No clinically or pathologically involved lymph nodes
* No distant metastases or significant obstructive symptoms
* No prior chemotherapy, pelvic radiation, transurethral prostatectomy (TURP), cryosurgery, TUNA, transurethral microwave thermotherapy (TUMT) or radical surgery for carcinoma of the prostate is allowed.
* No previous hormonal therapy beginning \< 2 months or \> 6 months prior to registration is allowed.
* No previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless the patient is disease free for ≥ 5 years.
* No hip prosthesis or major medical or psychiatric illnesses are allowed. prior to study entry.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00899912
Study Brief:
Protocol Section:
NCT00899912