A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD

Prostate Cancer Clinical Trial

— ICELAND  

Official title:

A Phase IIIb Randomized Study of Intermittent Versus Continuous Androgen Deprivation Therapy Using ELIGARD 22.5 mg 3-month Depot in Subjects With Relapsing and Locally Advanced Prostate Cancer Who Are Responsive to Such Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378690
• Other study ID #: EGD-EC-003
• Secondary ID: 2005-004094-25
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2006
• Last updated: June 2, 2014
• Start date: March 2006
• Est. completion date: December 2012

Study information

• Verified date: June 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesHungary: National Institute of PharmacyIreland: Irish Medicines BoardItaly: Ethics CommitteeNetherlands: Independent Ethics CommitteePoland: Ministry of HealthPortugal: National Pharmacy and Medicines InstituteSlovakia: State Institute for Drug ControlSpain: Ministry of HealthSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNorway: Norwegian Medicines AgencyRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will enter a long-term follow-up period for 48 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 706
• Est. completion date: December 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

At study entry (visit 1):

• Written informed consent

• Male subjects aged >=18 and <80 years old

• Locally advanced (stage T3 or T4) prostate cancer or Relapsing prostate cancer following radical prostatectomy or,Relapsing prostate cancer following radiotherapy

• Gleason score of >=6

• ECOG performance status of 0-2.

• Life expectancy at least 5 years

At randomization (visit 4):

• Two successive decreasing serum PSA levels <=1 ng/ml

Exclusion Criteria:

At study entry (visit 1):

• Any suspected second primary tumors

• Evidence of metastatic disease

• Other malignancy within the last 5 years except

• Acute spinal cord compression, uni- or bilateral ureteric obstruction

• Any concurrent biological response modifier therapy

• Concurrent chemotherapy

• Less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy

• Less than 6 months since prior 5-alpha reductase inhibitor treatment

• Other concurrent hormonal therapy

• Any concurrent radiotherapy

• Testosterone at screening <= 1.7 mM or 50 ng/dL

• Clinically significant elevation of serum creatinine or liver enzymes

• Hypersensitivity to GnRH or other GnRH analogues or leuprorelin acetate

• Hypersensitivity to CASODEXâ 50 mg.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• leuprorelin acetate
LHRH antagonist

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Finland,  France,  Germany,  Hungary,  Italy,  Russian Federation,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to PSA progression		3 Years	No
Secondary	Overall survival		5 Years	No
Secondary	World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status		3 Years	No
Secondary	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25		3 Years	No
Secondary	Time to serum testosterone > 50 ng/dL		3 Years	No
Secondary	Change in progression biomarkers (some sites)		3 Years	No

External Links

•   Link to Results on JAPIC