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

Study Overview
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Brief Summary
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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
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LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Lanreotide, non steroidal anti androgens and LHRH-a
* Drug: Non steroidal anti androgens and LHRH-a


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm A<br> | Drug: Non steroidal anti androgens and LHRH-a<br>* 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<br>|
| Experimental: Arm B<br> | Drug: Lanreotide, non steroidal anti androgens and LHRH-a<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival |  | Week 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate Specific Antigen (PSA) Response |  | Week 96 | 
| Median Time to PSA Response |  | Week 96 | 
| Reduction in Chromogranin A Serum Levels |  | Baseline, Week 96 |