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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT00573833
Eligibility Criteria:
DISEASE CHARACTERISTICS:
Inclusion criteria:
* Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:
* PSA 10-20 ng/mL
* Gleason score ≥ 7
* Stage ≥ T2b AND \< T3
* Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT)
* Prostate size \< 60 cc by MRI or CT imaging
* International Prostate Symptom Score Index ≤ 15
Exclusion criteria:
* Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)
* Suspected extracapsular disease will not be considered an exclusion criteria
* PSA \> 20 ng/mL
* Presence of distant metastases
PATIENT CHARACTERISTICS:
* WBC ≥ 3,500/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 10 g/dL
* Creatinine ≤ 1.5 mg/dL
* Liver function tests ≤ 1.5 times normal
* INR ≤ 2.5
* Able to complete quality of life questionnaires
* Able to give informed consent
* No active perineal infections
* No history of urethral stricture
* No prior history of pelvic malignancy
* No prior history of lymphoma disease, ulcerative colitis, or anal fissures
* No contraindications to general anesthesia
* No pacemaker
PRIOR CONCURRENT THERAPY:
* No prior transurethral resection of the prostate
* No prior pelvic radiotherapy
* No prior treatment for prostate cancer except for hormone therapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00573833
Study Brief:
Protocol Section:
NCT00573833