Prostate Cancer
Conditions
Keywords
HRPC, octreotide LAR, CgA
Brief summary
The present study will provide information on whether the somatostatin analog, octreotide acetate, could have an inhibitory effect on circulating chromogranin A. The demonstration of an antisecretory effect of somatostatin analogs could offer a rationale for a large scale randomized study.
Interventions
DRUGOctreotide LAR
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Exclusion criteria
1. Prior chemotherapy or other systemic anticancer therapy except for LHRH agonists, and/or non-steroidal anti-androgens (eg, flutamide, bicalutamide or nilandron) 2. Palliative radiotherapy less than 6 weeks (42 days) prior to planned entry date 3. Other investigational drugs within the past 28 days 4. Long-term (\> 3 months) treatment with proton pump inhibitors 5. Uncontrolled blood hypertension 6. Other malignancies within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer 7. Patients with another non-malignant disease which would confound the evaluation of the primary endpoints or prevent the patient from complying with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to 25% decrease in chromogranin A plasma level (evaluation every 4 weeks for the first 12 weeks and every 12 weeks after) | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA response (decrease > 50% or increase > 25% from baseline) | — |
| Time to symptomatic progression (bone pain increase, deterioration of ECOG performance status) | — |
| Change in circulating IGF-1, VEGF, IL-6, serum alkaline phosphatase, serum creatinine and serum calcium every 4 weeks for the first 12 weeks and every 12 weeks after | — |
Countries
Italy
Outcome results
None listed