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

NCT01313273 | Terminated Phase 3 Results

• 2 other identifiers: A-93-52030-7382010-019862-10
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Week 96

Secondary Outcomes (3)

• Prostate Specific Antigen (PSA) Response

  Week 96

• Median Time to PSA Response

  Week 96

• Reduction in Chromogranin A Serum Levels

  Baseline, Week 96

Study Arms (2)

Arm A

OTHER

Drug: Non steroidal anti androgens and LHRH-a

Arm B

EXPERIMENTAL

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

Interventions

Lanreotide, non steroidal anti androgens and LHRH-a DRUG

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.

Arm B

Non steroidal anti androgens and LHRH-a DRUG

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

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \[cut off levels will be \> 20 U/L for enzyme linked immunosorbent (ELISA) assay and \> 100 ng/ml for immunoradiometric (IRMA) assay\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

A.O. S. Luigi Gonzaga

Orbassano ( TO), Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Study terminated due to poor enrollment

Results Point of Contact

• Title: Medical Director, Oncology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 11, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 22, 2019
• Results First Posted: August 14, 2015

Record last verified: 2019-11

Locations

IT (1)