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

Astellas

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: leuprorelin acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00378690

2005-004094-25 (EudraCT Number)

EGD-EC-003

Details and patient eligibility

About

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.

Enrollment: 706 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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706 participants in 2 patient groups

Continuous Androgen Deprivation (CAD)

Active Comparator group

Treatment:

Drug: leuprorelin acetate

Intermittent Androgen Deprivation (IAD)

Experimental group

Treatment:

Drug: leuprorelin acetate