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

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Androgen Antagonists; Androgens; Angiopeptin; Ascorbic Acid; Estrogens, Conjugated (USP); Lanreotide; Methyltestosterone; Nonsteroidal Anti-Androgens; Prolactin Release-Inhibiting Factors; Somatostatin

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