Alliance Urology Specialists

Prostate Cancer

	Trial Status OPEN TO ENROLLMENT Protocol Number: FE200486 CS35 00/2009 - Present Sponsor: Ferring Pharmaceuticals Title: An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen with Goserelin Acetate in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy Purpose of Study The trial is designed to demonstrate that degarelix three-month dosing regimen is effective and non-inferior to goserelin with respect to achieving and maintaining testosterone suppression in prostate cancer patients. For further information click here. Trial Status OPEN TO ENROLLMENT Protocol Number: FE200486 CS37 04/2009 - Present Sponsor: Ferring Pharmaceuticals Title: A Randomized, Controlled, Open-Label Trial of Degarelix Intermittent Therapy vs. Continuous Androgen Deprivation Therapy with Leuprolide or Degarelix in Patients with Carcinoma of the Prostate with Biochemical Failure after Localized Therapy. Purpose of Study The main focus of this medication program is to develop a therapy for prostate cancer patients in need of hormone therapy, and to establish dosing regimens which can be administered once-monthly or once every three months by subcutaneous injection. For further information click here. Ongoing Clinical Trials Trial Status CLOSED TO ENROLLMENT Protocol Number: AMGEN 20050103 05/2006 - Present Sponsor: Amgen, Inc. Title: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa?) in the Treatment of Bone Metastases in Men with Hormone-Refractory Prostate Cancer. Purpose of Study We are currently conducting this clinical trial for men with prostate cancer who have been on hormone therapy and have bone metastases. This study is comparing two medications in the treatment of bone metastases. For further information click here. Trial Status CLOSED TO ENROLLMENT Protocol Number: FE200486 CS21A 11/2006 - Present Sponsor: Ferring Pharmaceuticals Title: An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients with Prostate Cancer Requiring Androgen Ablation Therapy. An extension study to evaluate long-term safety, tolerability, and efficacy of one-month dosing regimen of degarelix for treatment of prostate cancer. Purpose of Study We are currently conducting an extension study for men with prostate cancer who have been on hormone therapy. Only patients who have completed the FE 200486 CS21 study will be enrolled in this study. This study is evaluating the long term safety and tolerability of a medication used in the treatment of prostate cancer. For further information click here. Trial Status CLOSED TO ENROLLMENT Protocol Number: REDEEM-AVO105948 08/2006 - Present Sponsor: GlaxoSmithKline Title: A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride in Extending the Time to Progression of Low-Risk, Localized Prostate Cancer in Men who are Candidates for or Undergoing Expectant Management. Purpose of Study We are currently conducting a study for men diagnosed with low-risk, localized disease who are candidates for or undergoing (expectant management). Expectant management is defined as actively monitoring the course of disease with the expectation to intervene if the cancer progresses or if symptoms become imminent. This study is assessing the efficacy and safety of a medication in extending the time to progression of prostate cancer. For further information click here. List of Completed Trials for Prostate Cancer Protocol Number: SWOG 02/1994 – 10/2005 Sponsor: Southwest Oncology Group Title: A study of Finasteride / Placebo for prostate cancer chemoprevention in high risk men. Protocol Number: MOO-244, 211, 258 05/2002 – 03/2006 Sponsor: Abbott Laboratories Title: A placebo controlled study of the safety and efficacy of Atrasentan in the treatment of hormone refractory prostate cancer. Protocol Number: MPR-7869-001 05/2002 – 06/2006 Sponsor: Myriad Pharmaceuticals, Inc. Title: Phase IIb, multicenter, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of MPR-7869 in delaying the systemic progression of prostate cancer in patients with intermediate to high risk of recurrence. Protocol Number: USO5 04/2003 – 03/2005 Sponsor: Novartis Oncology Title: A double-blind, placebo controlled study of the effect of Zoledronic acid on bone mineral density in men receiving androgen-deprivation therapy for prostate cancer. Protocol Number: TBC-PRO-002 10/2003 – 03/2006 Sponsor: Therion Biologics Title: A phase II randomized, double blind, placebo controlled study to evaluate the safety and efficacy of PROSTVAC-VF/TRICOM in combination with GM-CSF in patient with androgen-independent adenocarcinoma of the prostate. Protocol Number: FE200486CS14 03/2004 – 06/2005 Sponsor: Ferring Pharmaceuticals Title: An open-label, randomized, multi-center, parallel group comparison of the efficacy and safety of Degarelix at two different dosing regiments in patients with prostate cancer dosed for thirteen 28-day cycles. Protocol Number: G300203 06/2004 – 11/2007 Sponsor: GTX, Inc. Title: A randomized, double-blind, placebo-controlled, trial of Toremifene citrate for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy. Protocol Number: FE200486 CS15 02/2005 – 02/2007 Sponsor: Ferring Pharmaceuticals Title: An open-label, multi-center, randomized parallel group comparison of efficacy and safety of Degarelix three-month depot in three different dosing regiments of 240mg (40mg/mL) and 240mg (60mg/mL) in patients with prostate cancer requiring androgen ablation therapy. Protocol Number: FE200486 CS14A 06/2005 – 08/2008 Sponsor: Ferring Pharmaceuticals Title: An open-label, multi-center, extension study investigating the long-term safety and tolerability of Degarelix one-month depots in patients with prostate cancer. Protocol Number: FE200486 CS21 12/2005 – 11/2007 Sponsor: Ferring Pharmaceuticals Title: An open-label, multi-centre, randomized, parallel-group study, investigating the efficacy and safety of Degarelix one month dosing regimens; 160 mg(40 mg/ml) and 80mg (20mg/ml), in comparison to Lupron depot ® 7.5 mg in patients with prostate cancer requiring androgen ablation therapy. Protocol Number: FE200486 CS15A 02/2006 – 08/2006 Sponsor: Ferring Pharmaceuticals Title: An open-label, multi-centre, extension study, evaluating the long-term safety and tolerability of different three-month Degarelix dosing regimens, 240 mg(40 mg/ml), 240 mg(60mg/ml), in patients with prostate cancer. Protocol Number: FE200486 CS18 05/2007 – 10/2008 Sponsor: Ferring Pharmaceuticals Title: An Open-Label, Multicenter, Randomized Parallel-Group Dose-Finding Study, Investigating efficacy and safety of Two Degarelix Three-Month Dosing Regimens in patients with Prostate Cancer requiring Androgen Ablation Therapy. Protocol Number: VEG101920 08/2007 – 08/2008 Sponsor: GlaxoSmithKline Title: A study for the Detection and Characterization of Circulating Tumor Cells in the Pherpheral Blood Circulation of Patients with Solid Tumor. Clinical Research Coordinators: Patricia Edwards, RN (336) 274-1114 ext. 5322 Karen Michael, RN (336) 274-1114 ext. 5328 E-mail address: research@allianceurology.com

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