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

Ipsen

Status and phase

Terminated

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Lanreotide, non steroidal anti androgens and LHRH-a

Drug: Non steroidal anti androgens and LHRH-a

Study type

Interventional

Funder types

Industry

Identifiers

NCT01313273

2010-019862-10 (EudraCT Number)

A-93-52030-738

Details and patient eligibility

About

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.

Full description

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Enrollment

3 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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