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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
History of Changes
  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:

U.S. FDA Resources

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
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 May 23, 2013