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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT00305669
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* No neuroendocrine or small cell features
* No evidence of metastatic disease
* Planning radical prostatectomy at least 2 months from now
* Testosterone level normal
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8 g/dL
* AST and ALT ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 1.5 times ULN
* PT and PTT normal
* Fertile patients must use effective barrier contraception
* No history of allergic reaction to compounds of similar chemical or biologic composition to sargramostim (GM-CSF)
* No ongoing or active bacterial, viral, or fungal infection
* DLCO \> 50% if patient has a history of clinically significant obstructive airway disease
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No other active malignancy, defined as cancer for which therapy has been completed and patient is now considered \< 30% risk of relapse, except nonmelanoma skin cancer
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No underlying medical condition that, in the opinion of the principal investigator, may make the administration of GM-CSF hazardous or obscure the interpretation of adverse events
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior major surgery
* No prior radiotherapy, immunotherapy, chemotherapy, or other investigational therapy for this cancer
* No prior hormonal therapy including any of the following:
* Luteinizing-hormone releasing hormone (LHRH) agonists
* LHRH antagonists
* Antiandrogens, including any of the following:
* Bilcalutamide
* Flutamide
* Nilutamide
* 5-alpha-reductase inhibitors
* PC-SPES or other PC-x product
* Estrogen-containing nutriceuticals
* No concurrent chemotherapy or radiotherapy
* No concurrent systemic steroid therapy
* Concurrent inhaled or topical steroids allowed
* No other concurrent immunotherapy
* No other concurrent investigational agent
* No other concurrent anticancer agents or therapies
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00305669
Study Brief:
Protocol Section:
NCT00305669