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

Inclusion criteria

• Male patients aged >18
• ECOG performance status < 3
• Patients with metastatic prostate cancer currently receiving 1st line hormonal therapy (LHRH agonists or surgical castration) and failing with raising serum PSA
• 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)
• Demonstrated tolerance to a test dose of s.c. octreotide acetate injection at Visit 1
• Elevated (> 40 U/L according to DAKO Elisa kit) chromogranin A plasma levels documented by at least two consecutive measurements
• Liver function tests < 2.5 ULN, serum creatinine within normality
• 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
• Immediate history of rising PSA < 10 months
• Castrate levels of testosterone (< 30 ng/dL)
• Life expectancy of > 6 months
• Signed informed consent prior to initiation of any procedure

Exclusion criteria

• Prior chemotherapy or other systemic anticancer therapy except for LHRH agonists, and/or non-steroidal anti-androgens (eg, flutamide, bicalutamide or nilandron)
• Palliative radiotherapy less than 6 weeks (42 days) prior to planned entry date
• Other investigational drugs within the past 28 days
• Long-term (> 3 months) treatment with proton pump inhibitors
• Uncontrolled blood hypertension
• Other malignancies within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer
• Patients with another non-malignant disease which would confound the evaluation of the primary endpoints or prevent the patient from complying with the protocol