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

• Conditions: Drug indicated for the treatment of hormone dependent advanced prostate cancer; MedDRA version: 6.1Level: PTClassification code 10060862

• Registration Number: EUCTR2005-004094-25-IT
• Lead Sponsor: ASTELLAS PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-04
• Last Update Posted: 22 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 700

Inclusion Criteria

1. Written informed consent has been obtained 2. Male subjects aged and equal 18 and and equal 80 years old 3. Histologically or cytologically confirmed adenocarcinoma of the prostate meeting the following criteria Locally advanced stage T3 or T4 prostate cancer, N0 or N , M0 with PSA and equal 5 ng/ml, or Relapsing prostate cancer following radical prostatectomy for clinically localized PCa with a serum PSA of and equal 0.4 ng/ml that has risen on three successive occasions values drawn at least 2 weeks apart as compared to a previous reference value or, Relapsing prostate cancer following radiotherapy with a serum PSA of and equal 1 ng/ml that has risen on three successive occasions values drawn at least 2 weeks apart as compared to a previous reference value. 4. Gleason score of and equal 6 5. Eastern Cooperative Oncology Group ECOG performance status of 0-2. 6. Life expectancy of at least 5 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any suspected second primary tumors, including evidence from special stains 2. Evidence of metastatic disease on bone scintigraphy or CT scan 3. Other malignancy within the last 5 years except; Adequately treated basal cell or squamous cell skin cancer Adequately treated other superficial cancer 4. Subjects with acute spinal cord compression, uni- or bilateral ureteric obstruction 5. Any concurrent biological response modifier therapy 6. Concurrent chemotherapy 7. Less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a duration of more than 4 months single or combination therapy is allowed 8. Less than 6 months since prior 5-alpha reductase inhibitor treatment for prostate cancer and BPH 9. Other concurrent hormonal therapy 10. Any concurrent radiotherapy 11. Testosterone at screening and equal to 1.7 uM or 50 ng/dL 12. Clinically significant elevation of serum creatinine or liver enzymes 13. Subjects with hypersensitivity to GnRH or other GnRH analogues or leuprorelin acetate or any of the excipients of ELIGARD 22.5 mg 14. Subjects with hypersensitivity to CASODEX 50 mg or any of the excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified