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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT00176605
Eligibility Criteria:
Inclusion Criteria
* Patients with histologically proven prostate cancer and tumors limited to the prostate (including seminal vesicle involvement, provided all visible disease was surgically removed) that have completed local therapy and have an rising PSA value, as defined in Section 5.1.5.
* Prior androgen ablation therapy is allowed as long as the patient completed therapy at least 1 year prior to entry into this study. The patient must be fully recovered from such therapy and must not have demonstrated progression while on androgen ablation therapy.
* Primary treatment to the prostate (surgery and/or radiation) must have been completed at least 3 months prior to entry into this study and the patient must be fully recovered from such therapy.
* Patients must have a negative CT of the chest, abdomen and pelvis and bone scan. The scans must be completed within 4 weeks prior to the date of starting therapy.
* PSA value for patients enrolled must be \> 2 ng/ml with a doubling time of £ 12 months. PSA value \> 2 ng/ml must be documented by two measurements at least four weeks apart. The final PSA measurement before study entry must be obtained within one week prior to therapy. This will be considered the baseline PSA. (Note: The website http://www.mskcc.org/mskcc/html/10088.cfm may be used to access a prostate normogram calculator.)
* The following lab values must be obtained within 4 weeks prior to therapy:
* ANC ≥1500/mm³,
* Hemoglobin ≥ 10 g/dl
* Platelet count ≥ 100,000/mm³
* Serum creatinine ≤ 1.5 mg/dL
* Total bilirubin ≤ 1.5 mg/dL
* Liver function tests (SGOT, SGPT) ≤ 1.5 times the upper limit of the institution's normal range.
* Men ≥ 18 years of age.
* An estimated life expectancy of at least 6 months.
* ECOG performance status ≤ 2.
* Able to give informed, written consent.
* Men must consent to using effective contraception (barrier method- latex condom) while on treatment and for 4 weeks after discontinuation of treatment.
Exclusion Criteria
* Patients with active infections or known infection with HIV (HIV testing will not be performed as part of this study).
* Any coexisting medical condition including uncontrolled cardiac, hepatic, renal or psychiatric disease defined as ³ Grade 3 (CTCAE Version 3).
* Concurrent use of other investigational agent.
* Patients that have previously received more than 2 months of therapy with any of the agents used in this study.
* PSA value \< 2 ng/ml.
* Prior chemotherapy in the past 5 years.
* Use of androgen ablation therapy within 1 year, or history of progression on androgen ablation therapy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00176605
Study Brief:
Protocol Section:
NCT00176605