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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT00814892
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Biochemically progressive disease defined by two serial PSA measurements obtained ≥ 1 week apart during ongoing optimal androgen-deprivation therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone \[LHRH\] agonist, or another equivalent hormonal agent)
* Concurrent LHRH agonist or high-dose bicalutamide required (unless patient has undergone prior orchiectomy)
* Has undergone prior standard primary therapy for prostate cancer (e.g., radical prostatectomy, radiotherapy, or an equivalent initial treatment directed towards localized prostate cancer)
* PSA 2.0-100.0 ng/mL
* Serum testosterone \< 50 ng/dL (unless undergoing antiandrogen monotherapy)
* No concurrent evidence of radiological or new clinically palpable metastatic cancer
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy ≥ 12 weeks
* WBC ≥ 3,500/µL
* Platelet count ≥ 100,000/µL
* Hemoglobin ≥ 10.0 g/dL
* Creatinine ≤ 2.0 mg/dL
* Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
* AST ≤ 2.5 times ULN
* Fertile patients must use effective contraception
* Willing to provide blood samples for research purposes
* Able to complete questionnaire(s) alone or with assistance
* Able to undergo leukapheresis
* No known immunodeficiency
* No other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only
* No concurrent serious illness
* No known history of positive PPD skin test
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior therapy
* More than 1 month since prior and no concurrent corticosteroids or other immunosuppressive agents
* Inhaled corticosteroids allowed
* More than 1 month since prior and no concurrent estrogens and/or ketoconazole
* More than 3 months since prior and no other concurrent investigational medicinal products
* More than 4 weeks since prior and no concurrent secondary hormonal maneuver with or without a peripheral antiandrogen (e.g., bicalutamide), PC-SPES, or any other herbal medicines used to treat prostate cancer
* No prior prostate cancer vaccine
* No other therapy for prostate cancer (e.g., chemotherapy, immunotherapy, radiotherapy, or new hormonal therapy) during and for 4 months after completion of study therapy
* No other concurrent standard therapy that is potentially curative or proven capable of extending life expectancy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00814892
Study Brief:
Protocol Section:
NCT00814892