Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients

Inclusion Criteria

• •1. Male patients aged \>18
• •2. ECOG performance status \< 3
• •3. Patients with metastatic prostate cancer currently receiving 1st line hormonal therapy (LHRH agonists or surgical castration) and failing with raising serum PSA
• •4. Biochemical progression documented by three consecutively rising serum PSA measurements, each separated from the other by at least 2 weeks, with the last measurement being 50% or greater than the nadir PSA achieved after the last therapeutic maneuver (i.e. first line hormonal therapy noted above)
• •5. Demonstrated tolerance to a test dose of s.c. octreotide acetate injection at Visit 1
• •6. Elevated (\> 40 U/L according to DAKO Elisa kit) chromogranin A plasma levels documented by at least two consecutive measurements
• •7. Liver function tests \< 2.5 ULN, serum creatinine within normality
• •8. Serum PSA (50% increased value) above 4 ng/mL for patients with intact prostate and \> 0.8 ng/mL for post prostatectomy patients at study entry
• •9. Immediate history of rising PSA \< 10 months
• •10. Castrate levels of testosterone (\< 30 ng/dL)
• •11. Life expectancy of \> 6 months
• •12. Signed informed consent prior to initiation of any procedure