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Trial · Interventional

TerminatedPhase 3Results postedRegistry data

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

Short name POSEIDON

NCTNCT01313273 (opens ClinicalTrials.gov in a new tab)Other idA-93-52030-738Other id2010-019862-10
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 3
Enrollment
3 participants (actual)
Sponsor
Ipsen · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Italy

Start
Jun 2011
Primary completion
Jun 2013
Completion
Jun 2013
First posted
11 Mar 2011 (estimated)
Last update posted
22 Nov 2019
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014
  1. Ph 3

    POSEIDON

    NCT01313273

    Jun 2011 to Jun 2013

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Lanreotide, non steroidal anti androgens and LHRH-aDrug
  • Non steroidal anti androgens and LHRH-aDrug

Arms2

  • Other

    Arm A

  • Experimental

    Arm B

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Progression-free Survival

    Time frame · Week 96

Secondary outcomes(3)

  1. Prostate Specific Antigen (PSA) Response

    Time frame · Week 96

  2. Median Time to PSA Response

    Time frame · Week 96

  3. Reduction in Chromogranin A Serum Levels

    Time frame · Baseline, Week 96

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Week 96

Progression-free Survival

GroupValue
Arm A: Non-steroidal Anti Androgens + LHRH-anot posted
Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-anot posted
Secondary and other outcome results(3)
Secondary outcome· Week 96

Prostate Specific Antigen (PSA) Response

GroupValue
Arm A: Non-steroidal Anti Androgens + LHRH-anot posted
Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-anot posted
Secondary outcome· Week 96

Median Time to PSA Response

GroupValue
Arm A: Non-steroidal Anti Androgens + LHRH-anot posted
Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-anot posted
Secondary outcome· Baseline, Week 96

Reduction in Chromogranin A Serum Levels

GroupValue
Arm A: Non-steroidal Anti Androgens + LHRH-anot posted
Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-anot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Arm A: Non-steroidal Anti Androgens + LHRH-aNon-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.–0 / 20 / 2
Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-aLanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.–0 / 11 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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