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

Sponsor
Ipsen (Industry)
Overall Status
Terminated
CT.gov ID
NCT01313273
Collaborator
(none)
3
Enrollment
1
Location
2
Arms
24
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Lanreotide, non steroidal anti androgens and LHRH-a
  • Drug: Non steroidal anti androgens and LHRH-a
Phase 3

Detailed Description

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

ArmIntervention/Treatment
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

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.

Outcome Measures

Primary Outcome Measures

  1. Progression-free Survival [Week 96]

Secondary Outcome Measures

  1. Prostate Specific Antigen (PSA) Response [Week 96]

  2. Median Time to PSA Response [Week 96]

  3. Reduction in Chromogranin A Serum Levels [Baseline, Week 96]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1A.O. S. Luigi GonzagaOrbassano ( TO)Italy

Sponsors and Collaborators

  • Ipsen

Investigators

  • Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ipsen
ClinicalTrials.gov Identifier:
NCT01313273
Other Study ID Numbers:
  • A-93-52030-738
  • 2010-019862-10
First Posted:
Mar 11, 2011
Last Update Posted:
Nov 22, 2019
Last Verified:
Nov 1, 2019

Study Results

Participant Flow

Recruitment DetailsSubjects ≥18 years meeting inclusion criteria were recruited for this study.
Pre-assignment DetailInvestigators screened 8 subjects. Randomised 3 subjects and 5 were not randomised.
Arm/Group TitleArm A: Non-steroidal Anti Androgens + LHRH-aArm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a
Arm/Group DescriptionNon-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
Period Title: Overall Study
STARTED21
COMPLETED00
NOT COMPLETED21

Baseline Characteristics

Arm/Group TitleArm A: Non-steroidal Anti Androgens + LHRH-aArm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-aTotal
Arm/Group DescriptionNon-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.Lanreotide 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.Total of all reporting groups
Overall Participants213
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
72.50
57.00
61.00
Age, Customized (Number) [Number]
>=65 years
1
50%
0
0%
1
33.3%
Between 18 and 65 years
1
50%
1
100%
2
66.7%
Sex: Female, Male (Count of Participants)
Female
0
0%
0
0%
0
0%
Male
2
100%
1
100%
3
100%
Region of Enrollment (participants) [Number]
Italy
2
100%
1
100%
3
100%

Outcome Measures

1. Primary Outcome
TitleProgression-free Survival
Description
Time FrameWeek 96

Outcome Measure Data

Analysis Population Description
Study early terminated due to poor enrollment.
Arm/Group TitleArm A: Non-steroidal Anti Androgens + LHRH-aArm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Arm/Group DescriptionNon-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.Lanreotide 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.
Measure Participants00
2. Secondary Outcome
TitleProstate Specific Antigen (PSA) Response
Description
Time FrameWeek 96

Outcome Measure Data

Analysis Population Description
Study early terminated due to poor enrollment
Arm/Group TitleArm A: Non-steroidal Anti Androgens + LHRH-aArm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Arm/Group DescriptionNon-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.Lanreotide 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.
Measure Participants00
3. Secondary Outcome
TitleMedian Time to PSA Response
Description
Time FrameWeek 96

Outcome Measure Data

Analysis Population Description
Study early terminated due to poor enrollment
Arm/Group TitleArm A: Non-steroidal Anti Androgens + LHRH-aArm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Arm/Group DescriptionNon-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.Lanreotide 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.
Measure Participants00
4. Secondary Outcome
TitleReduction in Chromogranin A Serum Levels
Description
Time FrameBaseline, Week 96

Outcome Measure Data

Analysis Population Description
Study early terminated due to poor enrollment
Arm/Group TitleArm A: Non-steroidal Anti Androgens + LHRH-aArm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Arm/Group DescriptionNon-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.Lanreotide 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.
Measure Participants00

Adverse Events

Time FrameAEs were reported from Baseline (visit 2) to visit 10 (week 96 - End of study)
Adverse Event Reporting Description All Adverse Events (AEs) documented for this study were treatment emergent. Overall, for 1 patient (100.0%) of Arm B at least one AE, at least one AE related to study treatment and at least one severe AE were reported.
Arm/Group TitleArm A: Non-steroidal Anti Androgens + LHRH-aArm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Arm/Group DescriptionNon-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.Lanreotide 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.
All Cause Mortality
Arm A: Non-steroidal Anti Androgens + LHRH-aArm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
Arm A: Non-steroidal Anti Androgens + LHRH-aArm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/2 (0%) 0/1 (0%)
Other (Not Including Serious) Adverse Events
Arm A: Non-steroidal Anti Androgens + LHRH-aArm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/2 (0%) 1/1 (100%)
Gastrointestinal disorders
Diarrhoea0/2 (0%) 01/1 (100%) 3
Investigations
Transaminases increased0/2 (0%) 01/1 (100%) 1

Limitations/Caveats

Study terminated due to poor enrollment

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleMedical Director, Oncology
OrganizationIpsen
Phoneclinical.trials@ipsen.com
Emailclinical.trials@ipsen.com
Responsible Party:
Ipsen
ClinicalTrials.gov Identifier:
NCT01313273
Other Study ID Numbers:
  • A-93-52030-738
  • 2010-019862-10
First Posted:
Mar 11, 2011
Last Update Posted:
Nov 22, 2019
Last Verified:
Nov 1, 2019