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A Randomized, Open Label, Multicenter Study Evaluating the Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients


Phase 2
18 Years
80 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Randomized, Open Label, Multicenter Study Evaluating the 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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to 25% decrease in chromogranin A plasma level (evaluation every 4 weeks for the first 12 weeks and every 12 weeks after)

Principal Investigator

Novartis

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

CSMS995A2402

NCT ID:

NCT00166725

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • HRPC
  • octreotide LAR
  • CgA
  • Prostatic Neoplasms

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