Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients
Information source: Ipsen
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Lanreotide, non steroidal anti androgens and LHRH-a (Drug); Non steroidal anti androgens and LHRH-a (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Ipsen Official(s) and/or principal investigator(s):
Stefan Lempereur, MD, Study Director, Affiliation: Ipsen
Overall contact:
Ipsen Recruitment Enquiries, Email: clinical.trials@ipsen.com
Summary
The aim of the study is to compare in an exploratory fashion the efficacy on
progression-free survival of lanreotide in addition to non steroidal anti androgens and
LHRH-a in non metastatic castrate resistant prostate cancer patients.
Clinical Details
Official title: Randomised, Phase III Multicenter, Open Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients Presenting Elevated Chromogranin A Levels
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Progression-free survival
Secondary outcome: Prostate specific antigen (PSA) responseMedian time to PSA response Reduction in Chromogranin A serum levels
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Histologically proven diagnosis of prostate cancer
- Evidence of PSA progression despite castrate levels of testosterone (<50 ng/dL)
following orchiectomy or during therapy with luteinizing hormone releasing hormone
agonists (LHRH-a)
- Chromogranin A elevation above normal range (confirmed by a second evaluation at
least 1 week later) [cut off levels will be > 20 U/L for enzyme linked immunosorbent
(ELISA) assay and > 100 ng/ml for immunoradiometric (IRMA) assay]
Exclusion Criteria:
- Patients with radiological signs of metastatic disease
- Patients who according to the investigator opinion are candidates to be treated
immediately with chemotherapy (e. g. docetaxel)
- Patients previously treated with total androgen ablation
- Previous or concomitant treatment with a somatostatin analogue
Locations and Contacts
Ipsen Recruitment Enquiries, Email: clinical.trials@ipsen.com
IRCCS Osp. Maggiore Policlinico, Milan, Italy
A.O. S. Luigi Gonzaga, Orbassano ( TO), Italy
Additional Information
Starting date: November 2011
Last updated: November 2, 2011
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