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

This study has been terminated.
(Poor enrolment)
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01313273
First received: March 10, 2011
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Lanreotide, non steroidal anti androgens and LHRH-a
Drug: Non steroidal anti androgens and LHRH-a
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised, Phase III Multicenter, Open Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients Presenting Elevated Chromogranin A Levels

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Week 96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prostate specific antigen (PSA) response [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Median time to PSA response [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Reduction in Chromogranin A serum levels [ Time Frame: Baseline, Week 96 ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313273

Locations
Italy
A.O. S. Luigi Gonzaga
Orbassano ( TO), Italy
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Stefan Lempereur, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01313273     History of Changes
Other Study ID Numbers: A-93-52030-738
Study First Received: March 10, 2011
Last Updated: April 23, 2013
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Androgens
Lanreotide
Angiopeptin
Nonsteroidal Anti-Androgens
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Antineoplastic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014