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

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

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.

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

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