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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT00392535
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:
* Clinical stage T1b-T3a, N0, M0
* Locally confined disease
* Previously untreated disease
* Prostate-specific antigen (PSA) ≤ 30 ng/mL
* Estimated risk of seminal vesicle involvement \< 30%
* Estimated risk of seminal vesicle involvement is defined as PSA + (\[Gleason score - 6\] x 10) (i.e., if Gleason score ≤ 6, then PSA must be ≤ 30 ng/mL; if Gleason score = 7, then PSA must be \< 20 ng/mL; if Gleason score = 8, then PSA must be \< 10 ng/mL; if Gleason score = 9 or 10 patient is ineligible)
PATIENT CHARACTERISTICS:
* WHO performance status 0 or 1
* Life expectancy \> 10 years (5 years for patients with poorly differentiated cancers)
* WBC \> 4,000/mm\^3
* Hemoglobin \> 11g/dL
* Platelet count \> 100,000/mm\^3
* No other active malignancy within the past 5 years except basal cell carcinoma
* No hip prosthesis or fixation that would interfere with standard radiation beam configuration
* No comorbid conditions likely to impact on the advisability of radical radiotherapy (e.g., previous inflammatory bowel disease, previous colorectal surgery, significant bladder instability, or urinary incontinence)
PRIOR CONCURRENT THERAPY:
* No prior pelvic radiotherapy
* No prior radical prostatectomy
* No prior androgen-deprivation therapy
* No concurrent full anticoagulation therapy with warfarin or heparin
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00392535
Study Brief:
Protocol Section:
NCT00392535