A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: leuprorelin acetate (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Medical Affairs Europe, Astellas Pharma Europe Limited Lovett House
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time to PSA progression
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Bruxelles 1200, Belgium
Liege 4000, Belgium
Jette 1090, Belgium
Bruxelles 1070, Belgium
Leuven B-3000, Belgium
Bmo 65691, Czech Republic
Jablonec nad Nisou 46660, Czech Republic
Olomouc 7521, Czech Republic
Usti nad Labem 40113, Czech Republic
Tampere FIN-33521, Finland
Joensuu FIN-80210, Finland
Paris 75007, France
Toulon 83000, France
Bordeaux 33073, France
Paris 94275, France
Caen-Cedex 14033, France
Suresnes 92151, France
Nantes 44093, France
Cergy-Pontoise 95301, France
Avignon 84000, France
Ploemeur 53275, France
Brest 29609, France
Pierre-Benite 69310, France
Rouen 76031, France
Paris 75014, France
Grenoble 38043, France
Marseille 13915, France
Toulouse 31054, France
Hagenow 19230, Germany
Neustadt i. Sachsen 01844, Germany
Dresden 01324, Germany
Bautzen 02625, Germany
Trier 54290, Germany
Bad Neuenaher 53474, Germany
Hettstedt 06333, Germany
Halle/Saale 06132, Germany
Leipzig 04105, Germany
Dresden 01307, Germany
Szolnok 5000, Hungary
Veszprem 8200, Hungary
Nyiregyhaza 4400, Hungary
Budapest 1106, Hungary
Tatabanya 2800, Hungary
Kaposvar 7400, Hungary
Bergamo 24128, Italy
Bologna 40138, Italy
Parma 43100, Italy
Roma 00189, Italy
St. Petersburg 198255, Russian Federation
Moscow 125101, Russian Federation
Moscow 115478, Russian Federation
St. Petersburg 198013, Russian Federation
Moscow 125284, Russian Federation
Martin 03659, Slovakia
Skalica 90982, Slovakia
Trencin 91101, Slovakia
Barcelona 8003, Spain
Valencia 46009, Spain
Barcelona 8035, Spain
Barcelona 8036, Spain
Madrid 28041, Spain
Alcorcon, Madrid 28922, Spain
Desio, Milano 20033, Italy
Additional Information
Starting date: March 2006
Ending date: April 2011
Last updated: January 10, 2008
|
