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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT00258466
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Stage I-III disease (T1-T3, N0, M0)
* No clinical or radiographic evidence of metastasis
* If prostate-specific antigen (PSA) ≥ 10.0 ng/mL and Gleason score is 7, a radioisotope bone scan must show no evidence of metastasis
* No evidence of lymphatic or visceral metastases of the abdomen or pelvis on CT scan or MRI
* PSA ≤ 20 ng/mL
* Gleason score ≤ 7 (if stage T3 , score must be \< 7)
PATIENT CHARACTERISTICS:
Performance status
* Not specified
Life expectancy
* More than 10 years
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Endocrine therapy
* Prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following:
* Luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide)
* Anti-androgens (e.g., flutamide, bicalutamide)
Radiotherapy
* No prior pelvic irradiation
Surgery
* No prior radical prostatectomy
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00258466
Study Brief:
Protocol Section:
NCT00258466