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

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Lanreotide, non steroidal anti androgens and LHRH-a

Non steroidal anti androgens and LHRH-a

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

A.O. S. Luigi Gonzaga

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Arm A

Arm B

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival

Secondary Outcome Measures

Prostate Specific Antigen (PSA) Response

Median Time to PSA Response

Reduction in Chromogranin A Serum Levels

Full Information

NCT ID

NCT01313273

First Posted

March 10, 2011

Last Updated

November 21, 2019

Sponsor

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT01313273

Brief Title

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

Acronym

POSEIDON

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Terminated

Why Stopped

Poor enrolment

Study Start Date

June 2011 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ipsen

4. Oversight

Data Monitoring Committee

5. 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.

Detailed Description

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Other

Arm Title

Arm B

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Lanreotide, non steroidal anti androgens and LHRH-a

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Non steroidal anti androgens and LHRH-a

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free Survival

Time Frame

Week 96

Secondary Outcome Measure Information:

Title

Prostate Specific Antigen (PSA) Response

Time Frame

Week 96

Title

Median Time to PSA Response

Time Frame

Week 96

Title

Reduction in Chromogranin A Serum Levels

Time Frame

Baseline, Week 96

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ipsen Medical Director

Organizational Affiliation

Ipsen

Official's Role

Study Director

Facility Information:

Facility Name

A.O. S. Luigi Gonzaga

City

Orbassano ( TO)

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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