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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT00309894
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Progressive disease after androgen deprivation AND meets 1 of the following criteria:
* Measurable disease
* Measurable lesions ≥ 10 mm with spiral CT
* Up to 5 lesions per organ and 10 lesions total should be identified as target lesions
* No measurable disease
* Patients with prostate-specific antigen (PSA)-only disease must have an elevated PSA
* PSA evidence for progressive disease consists of a PSA level of ≥ 5 ng/mL that has risen on ≥ 2 successive occasions, ≥ 2 weeks apart
* Patients with a positive bone scan must also have an elevated PSA
* Patients who received prior antiandrogen as a part of primary androgen ablation therapy must demonstrate disease progression after discontinuation of the antiandrogen
* Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values obtained ≥ 2 weeks apart, or documented osseous or soft tissue progression
* Patients receiving flutamide must have had ≥ 1 of the PSA values obtained ≥ 4 weeks after flutamide discontinuation
* Patients receiving bicalutamide or nilutamide must have had ≥ 1 of the PSA values obtained ≥ 6 weeks after antiandrogen discontinuation
* Testosterone \< 50 ng/dL
* PSA ≥ 5 ng/mL
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* No serious intercurrent infections or nonmalignant uncontrolled medical illnesses
* No psychiatric illnesses OR social situations that would limit compliance
* No active or uncontrolled autoimmune disease
* ALT and AST normal
* Bilirubin normal
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 times upper limit or normal (ULN)
* Hemoglobin ≥ 8 g/dL
* No other currently active malignancy except for nonmelanoma skin cancer
* No currently active malignancy defined as therapy completed with ≤ 30% risk of relapse
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Patients must continue primary androgen deprivation therapy with a luteinizing-hormone releasing-hormone (LHRH) analogue if they have not undergone orchiectomy
* No prior systemic chemotherapy for prostate cancer
* All other systemic chemotherapy must have been completed ≥ 2 years prior to study
* No other concurrent chemotherapy, immunotherapy, or radiotherapy
* Major surgery or radiation therapy completed ≥ 4 weeks prior to study
* No other concurrent corticosteroids, including routine use antiemetics
* No prior ketoconazole, aminoglutethimide, or corticosteroids for treatment of progressive prostate cancer
* No prior immunotherapy (e.g., vaccines or sargramostim GM-CSF)
* Patients receiving any other hormonal therapy (e.g., megestrol, finasteride, herbal product known to decrease PSA levels \[e.g., saw palmetto or PC-SPES\], or any systemic corticosteroid) must discontinue the agent ≥ 4 weeks prior to enrollment and progressive disease must be documented after discontinuation
* No initiation of bisphosphonate therapy within 1 month prior to starting study therapy
* Patients on stable doses that show tumor progression are allowed to continue bisphosphonate
* No concurrent supplements or complementary medicines/botanicals, except any combination of the following:
* Conventional multivitamin supplements
* Selenium
* Lycopene
* Soy supplements
* Vitamin E
* At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium)
* No other concurrent investigational or commercial anticancer agents or therapies
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
120 Years
Study:
NCT00309894
Study Brief:
Protocol Section:
NCT00309894