Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients

Phase 3

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Non steroidal anti androgens and LHRH-a; Drug: Lanreotide, non steroidal anti androgens and LHRH-a

• Registration Number: NCT01313273
• Lead Sponsor: Ipsen

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

Study Timeline

• Study First Submitted: 2011-03-10
• Study First Submitted QC: 2011-03-10
• Study First Posted: 2011-03-11
• Study Start: 2011-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2015-04-28
• Results First Submitted QC: 2015-08-06
• Results First Posted: 2015-08-14
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Non steroidal anti androgens and LHRH-a	-
Arm B	Lanreotide, non steroidal anti androgens and LHRH-a	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	Week 96

Secondary Outcome Measures

Name	Time	Method
Prostate Specific Antigen (PSA) Response	Week 96
Median Time to PSA Response	Week 96
Reduction in Chromogranin A Serum Levels	Baseline, Week 96

Trial Locations

Locations (1)

A.O. S. Luigi Gonzaga; 🇮🇹 Orbassano ( TO), Italy