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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT00313534
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed prostate cancer, meeting 1 of the following criteria:
* Androgen-dependent disease (testosterone ≥ 250 ng/mL)
* Androgen-independent disease (testosterone \< 50 ng/mL)
* Received prior definitive therapy for primary prostate cancer comprising any of the following:
* External-beam radiotherapy with or without hormonal therapy
* Brachytherapy with or without pelvic external-beam radiotherapy or hormonal therapy
* Radical prostatectomy with or without adjuvant or salvage radiotherapy
* Cryotherapy
* Must have evidence of disease progression, as evidenced by elevated prostate-specific antigen (PSA) that has risen serially from post-definitive therapy nadir on 2 determinations taken ≥ 1 week apart
* Elevated PSA, meeting 1 of the following criteria:
* At least 1.0 ng/mL post radiotherapy or cryotherapy
* At least 4 ng/mL post radical prostatectomy
* Must show disease progression after discontinuation of the antiandrogen (for patients with androgen-dependent disease receiving antiandrogen as part of primary androgen ablation)
* No metastatic disease, confirmed by negative bone scan and negative CT scan or MRI of abdomen/pelvis
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Absolute neutrophil count ≥ 1,500/mm³
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* AST ≤ 1.5 times ULN
* No other medical condition that would interfere with study therapy or compliance
* No other active malignancy except previously treated squamous cell or basal cell skin cancer or cancer that has been treated and considered to be at \< 30% risk of relapse
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 8 weeks since prior strontium-chloride Sr 89
* More than 4 weeks since first dose of bisphosphonates
* More than 4 weeks since prior major surgery or radiotherapy
* At least 4 weeks since prior hormonal agents, including megestrol or steroids
* Concurrent luteinizing hormone-releasing hormone analogs allowed to maintain castrate levels of testosterone
* At least 4 weeks since prior and no concurrent saw palmetto, finasteride, or any herbal agent intended to lower PSA
* Prior adjuvant or neoadjuvant androgen-deprivation therapy allowed for androgen-dependent prostate cancer provided that all of the following are met:
* No more than 8 months of androgen deprivation
* At least 12 months since last day of effective androgen deprivation
* Testosterone \> 250 ng/mL at enrollment
* Prior hormonal therapy, chemotherapy, or investigational therapy for biochemical relapse allowed
* No concurrent chemotherapeutic, immunotherapeutic, or other investigational agents
* No concurrent radiotherapy
* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00313534
Study Brief:
Protocol Section:
NCT00313534