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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT00002633
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven locally advanced adenocarcinoma of the prostate, defined as 1 of the following:
* T3-4, N0 or NX, M0
* T2, PSA greater than 40 µg/L
* T2, PSA greater than 20 µg/L AND Gleason score at least 8
* Diagnosis made within the past 6 months
* Gleason score and PSA known
* Pelvic lymph nodes must be clinically negative
* Lymph nodes no more than 1.5 cm in greatest diameter by CT scan or MRI of the pelvis
* Negative needle aspirate required for any lymph node more than 1.5 cm
* If a lymph node dissection was performed, it must be histologically negative
* No small cell or transitional cell carcinoma by biopsy
* No bony metastases by bone scan
PATIENT CHARACTERISTICS:
Age:
* Under 80
Performance status:
* ECOG 0-2
Life expectancy:
* At least 5 years excluding malignancy
Hematopoietic:
* Hemoglobin at least 10.0 g/dL
* WBC at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 2 times upper limit of normal (ULN)
* SGOT and SGPT less than 2 times ULN
* Alkaline phosphatase less than 2 times ULN
* No history of chronic liver disease
Renal:
* Creatinine less than 2 times ULN
Other:
* No contraindication to wide-field pelvic irradiation (e.g., inflammatory bowel disease or severe bladder irritability)
* No other malignancy within the past 5 years except nonmelanoma skin cancer
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Prior hormonal therapy within the past 12 weeks allowed provided the following conditions are met:
* Negative bone scan before beginning any hormonal therapy
* Extracapsular extension remains palpable on rectal re-exam
* Baseline PSA known before beginning any hormonal therapy
* At least 4-6 weeks since prior 5-alpha-reductase inhibitor (e.g., finasteride) for benign prostatic hypertrophy
Radiotherapy:
* No prior pelvic irradiation
Surgery:
* No prior radical prostatectomy
* Prior transurethral resection of the prostate allowed
Other:
* No prior cytotoxic anticancer therapy
* No other prior treatment for prostate cancer
* No other concurrent anticancer therapy unless documented disease progression
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
79 Years
Study:
NCT00002633
Study Brief:
Protocol Section:
NCT00002633