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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00005067
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven locally recurrent prostate adenocarcinoma previously treated with definitive radiotherapy
* No T3 or T4 primary tumors
* No evidence of regional or distant metastases by MRI or bone scan
* No pathologic demonstration of malignancy in pelvic or abdominal lymph nodes
* Prostate gland volume no greater than 50 mL by MRI or ultrasound
* PSA no greater than 20 ng/mL
* Performance status - ECOG 0-2
* WBC at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* No severe liver disease (e.g., cirrhosis or grade III-IV elevations in liver function studies)
* Bilirubin no greater than 1.5 mg/dL
* Creatinine normal
* Creatinine clearance at least 60 mL/min
* Medical suitability for implantation
* Fertile patients must use effective contraception during and for 6 months after study participation
* No history of grade III or IV genitourinary or gastrointestinal toxicity
* No known G6PD deficiency
* No porphyria
* At least 4 weeks since prior gene therapy
* At least 4 weeks since prior immunotherapy
* At least 4 weeks since prior combination chemotherapy
* No concurrent chemotherapy
* At least 4 weeks since prior hormonal therapy
* No concurrent hormonal therapy
* No prior cryosurgery for prostate cancer
* No other concurrent medication for prostate cancer
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00005067
Study Brief:
Protocol Section:
NCT00005067