Randomised, Phase III Multicenter, Open Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients Presenting Elevated Chromogranin A Levels

Ipsen1 site in 1 country3 target enrollmentJune 2011

ConditionsProstate Cancer

InterventionsNon steroidal anti androgens and LHRH-a Lanreotide, non steroidal anti androgens and LHRH-a

DrugsLanreotide, non steroidal anti androgens and LHRH-a Non steroidal anti androgens and LHRH-a

Overview

Phase: Phase 3
Intervention: Non steroidal anti androgens and LHRH-a
Conditions: Prostate Cancer
Sponsor: Ipsen
Enrollment: 3
Locations: 1
Primary Endpoint: Progression-free Survival
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

June 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility 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)
•Patients with non-metastatic or stable metastatic disease
•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 who according to the investigator opinion are candidates to be treated immediately with chemotherapy (e.g. docetaxel)
•First line treatment with antiandrogen in monotherapy
•Visceral metastasis
•Previous or concomitant treatment with a somatostatin analogue