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CLINICAL TRIALS PROFILE FOR ELIGARD

Clinical Trials for Eligard

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00220194	A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer	Completed	San Bernardino Urological Associates Medical Group Inc	Phase 4	Comparing the effect of switching from Lupron and Zoladex to Eligard. PSA and Testosterone levels are measured at set intervals to determine if Eligard is equal or better then Lupron or Zoladex in advanced Prostate Cancer patients.
NCT00283062	Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy	Completed	Sanofi	Phase 3	This is a prospective, multicenter, open-label, randomized phase III study in participants at high risk of recurrent prostate cancer after radical prostatectomy. The study will investigate - Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate (ELIGARD®) versus leuprolide acetate alone (ELIGARD®) - Immediate treatment following prostatectomy versus deferred treatment at the time of relapse Using a 2x2 factorial design participants will therefore be randomized to - Immediate adjuvant treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) - Immediate adjuvant treatment with leuprolide acetate alone (hormonal therapy) - Deferred treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) - Deferred treatment with leuprolide acetate alone (hormonal therapy) Primary Objective: - The primary objective of the study is to compare progression-free survival using a 2x2 factorial design Secondary Objectives: - To compare the 5-year overall, cancer-specific and metastasis-free survival after systemic treatment between the groups - To compare the safety and tolerability between Docetaxel in combination with leuprolide acetate and leuprolide acetate alone. - To evaluate quality of life as measured by the FACT-P questionnaire. Originally, 1696 participants were planned in the study (with 424 participants randomized to each arm). However, only a total of 211 participants completed the randomization procedure as of 26 September 2007. Thus, sanofi-aventis, in accordance with the Steering Committee, decided to stop the participant recruitment as of 26 September 2007. Participants who had already signed their Informed Consent (IC) before September 26, 2007 were allowed to enter the randomization if they met eligibility criteria. The final revised number of planned participants to be randomly assigned to the 4 treatment arms was 250, and 228 participants were actually randomized. The final sample size did not allow all the statistical analyses to be conducted on efficacy data. Therefore, the protocol was amended to reflect the change in the plans for statistical analysis. The study was underpowered to serve as the basis for drawing conclusions regarding efficacy and quality of life (QoL) endpoints.
NCT00378690	A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD	Completed	Astellas Pharma Inc	Phase 3	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.
NCT00452556	The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study	Active, not recruiting	Nova Scotia Cancer Centre	Phase 2	The purpose of this study is to see if sequence inversion of Intensity - modulated Radiotherapy (IMRT) for prostate cancer, can improve the safety and deliverability of concurrent docetaxel chemotherapy with long - term hormonal therapy. The hypothesis is that inverting the traditional sequence of radiotherapy can delay the time to treatment - induced bowel toxicity.
NCT01136226	Evaluate Recovery of Testosterone for Patients Using Eligard	Completed	Sanofi-Synthelabo	Phase 4	The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.
Trial ID	Title	Status	Sponsor	Phase	Summary