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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT00694551
Eligibility Criteria:
Inclusion Criteria:
* History of histologically confirmed prostate cancer.
* Competence to understand the patient information and provide written informed consent, and willingness and ability to return to H. Lee Moffitt Cancer Center for planned treatments and follow-up.
* Absence of evidence of metastatic disease by current physical exam or by current imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\] pelvis, and bone scan within 60 days of first treatment).
* Patients not on hormone therapy (stratum "N") must meet all of these:
1. At least 1 year after prostatectomy, definitive prostate radiation, or other definitive-intent local therapy.
2. No testosterone suppression therapy for at least 6 months.
3. PSA at least 1 ng/ml, on 2 measurements, at least 2 weeks apart.
4. Testosterone level \>100 ng/ml, at start ("noncastrate").
* Patients on hormone therapy (stratum "Y") must meet all of these:
1. On treatment with gonadotropin-releasing hormone (GnRH) agonist (or orchiectomy) at least 6 months.
2. testosterone level \<50 ng/ml, at start.
3. PSA at least 1 ng/ml, on 2 measurements, at least 2 weeks apart.
* Laboratory values obtained 0-14 days prior to start of therapy:
1. White blood count (WBC) over 3,500/micro L.
2. Platelet count over 100,000 micro L.
3. Hemoglobin over 10.0 g/dL.
4. Serum creatinine up to 2.0 mg/dL.
5. Alkaline phosphatase up to 2.5 x upper limit of normal (ULN).
6. Aspartic transaminase (AST) up to 2.5 x ULN.
* Life expectancy at least 6 months.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
Exclusion Criteria:
* Known standard therapy for the patient's disease that is potentially curative.
* A known immunodeficiency including HIV. Appropriate trials for individuals with HIV may be considered at a later date.
* History of other malignancy besides prostate cancer in the last 5 years, except non-melanoma skin cancer treated with local resection only. (The effect of study treatment on other, potentially dormant malignant diseases is not known).
* Use of oral or inhaled or parenteral corticosteroids or of other immunomodulatory drugs within the 60 days of start. \[Use of steroids after start will be considered by the principal investigator (PI) on a case-by-case basis.\]
* Use of estrogens (including herbal phytoestrogens) or ketoconazole within 30 days of start, or during the study.
* Failure to fully recover to grade 1 or better from effects of prior chemotherapy regardless of interval since last treatment.
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational agent in last 30 days (one month washout to start of treatment; patients could register but not start until the washout).
* Known hypersensitivity to one or more components of the study medication.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00694551
Study Brief:
Protocol Section:
NCT00694551