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 - ICELAND Study

• Conditions: Histologically or cytologically confirmed adenocarcinoma of the prostate (PCa) meeting the following criteria:- Locally adv. (stage T3 or T4) PCa, N0 or N+, M0 with PSA >= 5 ng/ml, or- Relapsing PCa following radical prostatectomy for clinically localized PCa with a serum PSA of >= 0.4 ng/ml or,- Relapsing PCa following radiotherapy with a serum PSA of >= 1 ng/ml as compared to a previous reference value.; MedDRA version: 8.0Level: LLTClassification code 10060862

• Registration Number: EUCTR2005-004094-25-ES
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-23
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

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

Inclusion Criteria

At study entry (visit 1):
1. Written informed consent has been obtained
2. Male subjects aged >= 18 and <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 >= 5 ng/ml, or
- Relapsing prostate cancer following radical prostatectomy for clinically localized PCa with a serum PSA of >= 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 >= 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 >= 6
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
6. Life expectancy of at least 5 years

At randomization (visit 4):
7. Two successive decreasing serum PSA levels =< 1 ng/ml (at least 2 weeks apart) following 6 months of complete androgen suppression
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

At study entry (visit 1):
1. Any suspected second primary tumors, including evidence from special stains (e.g. Prostatic acid phosphatase)
2. Evidence of metastatic disease on bone scintigraphy or CT scan (bone scintigraphy or CT scan from within 6 months of V1 is acceptable)
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 (progesterone preparations for the treatment of subjects presenting with hot flushes are permitted)
10. Any concurrent radiotherapy
11. Testosterone at baseline =< 1.7 mM or 50 ng/dL
12. Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 mmol/L, AST or ALT > 2x upper limit of normal range (ULN), g-GT > 3x ULN and/or abnormal clinically significant serum total bilirubin (as assessed at visit 1 lab sampling)
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.
15. Any clinical condition, which in the opinion of the investigator would not allow safe completion of the study.
16. Participation in any clinical study within 3 months, or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study.

Study & Design

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