Clinical trial NCT00378690: A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Prostate Specific Antigen
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-09-21
Enrollment: 706
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Time to PSA progression
timeFrame: 3 Years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 Years
measure: World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status
timeFrame: 3 Years
measure: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25
timeFrame: 3 Years
measure: Time to serum testosterone > 50 ng/dL
timeFrame: 3 Years
measure: Change in progression biomarkers (some sites)
timeFrame: 3 Years
Other outcomes:
Locations:
city: Brussel
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Bmo
country: Czech Republic
city: Jablonec nad Nisou
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Joensuu
country: Finland
city: Tampere
country: Finland
city: Avignon
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Caen-Cedex
country: France
city: Cergy-Pontoise
country: France
city: Grenoble
country: France
city: Marseille
country: France
city: Nantes
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Pierre-Benite
country: France
city: Ploemeur
country: France
city: Rouen
country: France
city: Suresnes
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Bad Neuenaher
country: Germany
city: Bautzen
country: Germany
city: Dresden
country: Germany
city: Dresden
country: Germany
city: Hagenow
country: Germany
city: Halle/Saale
country: Germany
city: Hettstedt
country: Germany
city: Leipzig
country: Germany
city: Neustadt i. Sachsen
country: Germany
city: Trier
country: Germany
city: Budapest
country: Hungary
city: Kaposvar
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szolnok
country: Hungary
city: Tatabanya
country: Hungary
city: Veszprem
country: Hungary
city: Desio
country: Italy
state: Milano
city: Ancona
country: Italy
city: Bari
country: Italy
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Chieti
country: Italy
city: Messina
country: Italy
city: Milano
country: Italy
city: Parma
country: Italy
city: Roma
country: Italy
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Martin
country: Slovakia
city: Skalica
country: Slovakia
city: Trencin
country: Slovakia
city: Alcorcon
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Granada
country: Spain
city: La Coruna
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: Tombal B, Cornel EB, Persad R, Stari A, Gomez Veiga F, Schulman C. Clinical Outcomes and Testosterone Levels Following Continuous Androgen Deprivation in Patients with Relapsing or Locally Advanced Prostate Cancer: A Post Hoc Analysis of the ICELAND Study. J Urol. 2017 Nov;198(5):1054-1060. doi: 10.1016/j.juro.2017.05.072. Epub 2017 May 25.
citation: Schulman C, Cornel E, Matveev V, Tammela TL, Schraml J, Bensadoun H, Warnack W, Persad R, Salagierski M, Gomez Veiga F, Baskin-Bey E, Lopez B, Tombal B. Intermittent Versus Continuous Androgen Deprivation Therapy in Patients with Relapsing or Locally Advanced Prostate Cancer: A Phase 3b Randomised Study (ICELAND). Eur Urol. 2016 Apr;69(4):720-727. doi: 10.1016/j.eururo.2015.10.007. Epub 2015 Oct 29.