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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT00006359
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Must have one of the following prognostic factors:
* Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason score \> 6
* Stage T1-2, N0; PSA \> 10 ng/mL and \< 20 ng/mL; and Gleason score ≤ 6
* Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6
* Prostate volume \< 60 cc by transrectal ultrasound
* No distant or nodal metastases
* No metastatic disease by bone scan, CT scan, or MRI
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic:
* Bilirubin ≤ 1.5 times upper limit of normal
Renal:
* Not specified
Other:
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy for prostate cancer
Chemotherapy:
* No prior chemotherapy for prostate cancer
Endocrine therapy:
* Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated within 4 weeks of study radiotherapy
* No other prior hormonal therapy
Radiotherapy:
* No prior radiotherapy for prostate cancer
Surgery:
* No prior surgery for prostate cancer
* No prior transurethral resection of the prostate
Other:
* No prior alternative therapy (e.g., PC-SPES) for prostate cancer
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00006359
Study Brief:
Protocol Section:
NCT00006359