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

Prostate Cancer Clinical Trial

— POSEIDON  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01313273
• Other study ID #: A-93-52030-738
• Secondary ID: 2010-019862-10
• Status: Terminated
• Phase: Phase 3
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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

Locations

Country	Name	City	State
Italy	A.O. S. Luigi Gonzaga	Orbassano ( TO)

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival		Week 96
Secondary	Prostate Specific Antigen (PSA) Response		Week 96
Secondary	Median Time to PSA Response		Week 96
Secondary	Reduction in Chromogranin A Serum Levels		Baseline, Week 96