Prostate Cancer Clinical Trials

This is a two-arm, randomized Phase II study of intermittent chemotherapy with and without GM-CSF. All patients will receive six 21-day cycles of docetaxel 75 mg/m2 on Day 2 of each cycle and 5 mg prednisone twice a day on Days 1-21. Following six cycles of chemotherapy, eligible subjects will be randomized to no maintenance therapy or to maintenance GM-CSF therapy. The GM-CSF group dose schedule will be 250 mcg/m2 SQ daily Days 15-28 every 28 days. Patients in both groups will continue until disease progression at which time GM-CSF will be discontinued and chemotherapy will again be administered.

Inclusion Criteria:

1. Age over 18 years
2. Histologically documented adenocarcinoma of the prostate
3. Progressive metastatic prostate cancer
4. Castrate levels of testosterone (<50 ng/ml) must be maintained

5. Prior hormonal therapy or medications :

   Patients who are receiving an anti-androgen, secondary hormonal therapy (i.e. ketoconazole, aminoglutethimide, megestrol acetate, diethylstilbestrol), 5-alpha reductase inhibitor (i.e. finasteride (Proscar), dutasteride (Avodart)) or herbal prostate medication (i.e. saw palmetto, PC-SPES, PC-PLUS) must discontinue the drug by the date of initiation of chemotherapy on study

6. ≥ 4 weeks since major surgery and fully recovered
7. ≥ 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to ≤grade 1
8. ≥ 8 weeks since the last dose of strontium or samarium
9. Sexually active patients must agree to use adequate contraception
10. Karnofsky Performance Status ≥ 60%
11. Life expectancy >12 weeks
12. Required initial laboratory values Absolute neutrophil count > 1500/ul Platelets > 100,000/ul Hemoglobin > 8.0 g/dl Creatinine ≤ 2.0 X upper limit of normal Bilirubin ≤upper limit of normal (ULN)

AST/ALT/alkaline phosphatase:

AST AND ALT AND alkaline phosphatase must be within the range allowing for eligibility In determining eligibility, the more abnormal of the 2 values (AST or ALT should be used. An abnormal alkaline phosphatase must be attributed to liver dysfunction and not metastatic bone involvement (i.e elevated GGTP or evidence of liver metastases)

Inclusion criteria for late enrolling patients:

1. Age over 18 years
2. Histologically documented adenocarcinoma of the prostate
3. ≤3 cycles of prior docetaxel chemotherapy for metastatic disease permitted prior to enrollment
4. Docetaxel must have been administered on an every 3 week schedule
5. Each docetaxel dose must have been between 60 and 75 mg/m2
6. Castrate levels of testosterone <50 ng/mL
7. Daily use of other steroids (hydrocortisone, dexamethasone) instead of prednisone or no steroids, is permitted up until time of enrollment
8. A PSA level must have been documented within 6 weeks of initiating docetaxel chemotherapy