Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for Patients With Rising Prostate-Specific Antigen (PSA)

Inclusion Criteria:

* Histologic diagnosis of adenocarcinoma of the prostate; stage T1-T3, N0-N1, M0
* Prior definitive therapy for primary prostate cancer consisting of:external beam radiotherapy;brachytherapy with or without pelvic external beam radiation; or radical prostatectomy with or without adjuvant or salvage radiation therapy
* Therapeutic PSA response to primary therapy below 1.0 ng/ml post radiation therapy or below 0.4 ng/ml for radical prostatectomy
* Patients treated with adjuvant or salvage radiation therapy following radical prostatectomy are eligible provided:Post prostatectomy PSA was never \> 6.0 ng/ml, last effective day of androgen deprivation is at least 3 months prior to study entry
* Recurrent PSA level elevation (between 0.4 ng/ml and 6.0 ng/ml) on two determinations at least one week apart.
* No clinical evidence of gross local recurrence or known metastatic disease other than PSA elevation. Transrectal ultrasound and/or biopsy to evaluate local recurrence is not required. All patients will receive a bone scan and CT scan of the abdomen to exclude metastases.
* Estimated life expectancy of at least 6 months.
* ECOG Performance status of 0 or 1.
* Willing and able to give informed consent.

Exclusion Criteria:

* Cryosurgery as definitive therapy of primary tumor.
* Any metastasis.
* No concurrent or prior malignancy is allowed except for the following: adequately treated basal or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
* Current systemic steroid therapy (inhaled or topical steroids acceptable).
* Prior hormonal therapy for treatment of progressive disease.
* Prior chemotherapy, immunotherapy, or therapy with other experimental agents for prostate cancer.
* Any surgery within the prior 4 weeks.
* Bilirubin and SGOT \> 2 x upper limit of normal.
* BUN and serum creatinine \> 2.0 times normal.
* No active congestive heart failure.
* If there is a history of clinically significant obstructive airway disease, a DLCO must exceed 50%.
* Active uncontrolled bacterial, viral or fungal infection until these conditions are corrected or controlled.
* Any underlying medical condition which in the principal investigator's opinion will make the administration of GM-CSF hazardous or obscure the interpretation of adverse events.
* PSA \> 6.0 ng/ml