A Phase II Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for the Treatment of Patients With Evidence of Serologic (PSA) Progression After Definitive Therapy for Localized Prostate Cancer
- 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
- Estimated life expectancy of at least 6 months.
- ECOG Performance status of 0 or 1.
- Willing and able to give informed consent.
- 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
- 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
- PSA > 6.0 ng/ml