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

November 21, 2019 updated by: Ipsen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Orbassano ( TO), Italy
        • A.O. S. Luigi Gonzaga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm B
Drug: Lanreotide, non steroidal anti androgens and LHRH-a

Lanreotide 120 mg. Injection every 28 days, to be administered till progression or for a maximum of 24 months.

Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression.
Other: Arm A
Drug: Non steroidal anti androgens and LHRH-a
Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival
Time Frame: Week 96
Week 96

Secondary Outcome Measures

Outcome Measure
Time Frame
Prostate Specific Antigen (PSA) Response
Time Frame: Week 96
Week 96
Median Time to PSA Response
Time Frame: Week 96
Week 96
Reduction in Chromogranin A Serum Levels
Time Frame: Baseline, Week 96
Baseline, Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

March 10, 2011

First Posted (Estimate)

March 11, 2011

Study Record Updates

Last Update Posted (Actual)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-93-52030-738
  • 2010-019862-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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