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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: leuprorelin acetate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive

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

Primary outcome: Time to PSA progression

Secondary outcome:

Overall survival

World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25

Time to serum testosterone > 50 ng/dL

Change in progression biomarkers (some sites)

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

Brussel, Belgium

Bruxelles 1070, Belgium

Bruxelles 1200, Belgium

Leuven B-3000, Belgium

Liege 4000, Belgium

Bmo 65691, Czech Republic

Jablonec nad Nisou 46660, Czech Republic

Olomouc 7521, Czech Republic

Usti nad Labem 40113, Czech Republic

Joensuu FIN-80210, Finland

Tampere FIN-33521, Finland

Avignon 84000, France

Bordeaux 33073, France

Brest 29609, France

Caen-Cedex 14033, France

Cergy-Pontoise 95301, France

Grenoble 38043, France

Marseille 13915, France

Nantes 44093, France

Paris 75007, France

Paris 75014, France

Paris 94275, France

Pierre-Benite 69310, France

Ploemeur 53275, France

Rouen 76031, France

Suresnes 92151, France

Toulon 83000, France

Toulouse 31054, France

Bad Neuenaher 53474, Germany

Bautzen 02625, Germany

Dresden 01324, Germany

Dresden 01307, Germany

Hagenow 19230, Germany

Halle/Saale 06132, Germany

Hettstedt 06333, Germany

Leipzig 04105, Germany

Neustadt i. Sachsen 01844, Germany

Trier 54290, Germany

Budapest 1106, Hungary

Kaposvar 7400, Hungary

Nyiregyhaza 4400, Hungary

Szolnok 5000, Hungary

Tatabanya 2800, Hungary

Veszprem 8200, Hungary

Ancona, Italy

Bari, Italy

Bergamo 24128, Italy

Bologna 40138, Italy

Chieti, Italy

Messina, Italy

Milano, Italy

Parma 43100, Italy

Roma 00189, Italy

Moscow 125284, Russian Federation

Moscow 125101, Russian Federation

Moscow 115478, Russian Federation

St. Petersburg 198013, Russian Federation

St. Petersburg 198255, Russian Federation

Martin 03659, Slovakia

Skalica 90982, Slovakia

Trencin 91101, Slovakia

Barcelona 8003, Spain

Barcelona 8035, Spain

Barcelona 8036, Spain

Granada, Spain

La Coruna, Spain

Madrid 28041, Spain

Madrid, Spain

Valencia 46009, Spain

Alcorcon, Madrid 28922, Spain

Desio, Milano 20033, Italy

Additional Information

Link to Results on JAPIC

Starting date: March 2006
Last updated: June 2, 2014

Page last updated: August 23, 2015

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