Clinical trial NCT00166725: Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients
Official title: A Randomized, Open Label, Multicenter Study Evaluating the Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: HRPC
octreotide LAR
CgA
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to 25% decrease in chromogranin A plasma level (evaluation every 4 weeks for the first 12 weeks and every 12 weeks after)
Secondary outcomes:
measure: PSA response (decrease > 50% or increase > 25% from baseline)
measure: Time to symptomatic progression (bone pain increase, deterioration of ECOG performance status)
measure: 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
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: Orbassano
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References: