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 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT00684905
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Biopsy-proven adenocarcinoma of the prostate
* Locally recurrent disease, defined by digital rectal examination and/or rising prostate-specific antigen (PSA)
* No evidence of nodal or distant metastasis (i.e., N0, M0) on physical examination, bone scan, or CT scan of the pelvis
* Clinical stage T1c-T3a disease at the time of recurrence
* PSA \< 10 ng/mL
* Prostate volume by transrectal ultrasonography \< 60 cc
* Received prior external beam radiotherapy
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* WBC ≥ 3,000/μL
* Platelet count ≥ 90,000/μL
* Hemoglobin ≥ 10 g/dL
* Alkaline phosphatase \< 2 times normal
* AST \< 2 times normal
* Normal prothrombin time and partial thromboplastin time
* No significant obstructive urinary symptoms (AUA score ≤ 16)
* No contraindication for general anesthesia
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior transurethral resection of the prostate
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00684905
Study Brief:
Protocol Section:
NCT00684905