Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer

Inclusion Criteria:

Histologic diagnosis of adenocarcinoma of the prostate
Completion of local therapy by surgery and/or ablative radiation therapy at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement
Rising prostate specific antigen (PSA) levels without scan evidence of metastatic disease
Asymptomatic or mildly symptomatic and life expectancy of at least 4 months

Exclusion Criteria:

Small cell or other variant prostate cancer histology
Evidence of immunosuppression
Prior treatment with androgen deprivation except if given neoadjuvantly or adjuvantly with radiation therapy or at time of prostatectomy. In this situation, no more than 24 months of androgen deprivation must have been given and treatment must not have been within 12 months prior to screening for this study.
Serum testosterone at screening < 50 ng/dL
Known bone metastases or lymph node involvement as determined by bone scan or computed tomography (CT) scan of the abdomen and pelvis within 4 weeks of study entry
Prior vaccine therapy for prostate cancer
Known allergic reactions to granulocyte-macrophage colony-stimulating factor (GM-CSF)
Severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Medical Monitor, excess risk associated with study participation or study agent administration