Trial Status
OPEN TO ENROLLMENT

Protocol Number:  SPI-153-10-1                   00/2011 - Present
Sponsor:  Spectrum Pharmaceuticals, Inc.
Title: An International, Multi Center, Open Label, Randomized Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix versus Goserelin Depot (Zoladex®) in Men with Prostate Cancer

Purpose of Study
This study will assess the efficacy and safety of a monthly dosing regimen of Ozarelix administered subcutaneously (SC) versus Goserelin (Zoladex®) depot administered subcutaneously (SC) in men with prostate cancer for whom hormonal therapy is indicated

For further information click here.

Trial Status
OPEN TO ENROLLMENT

Protocol Number:  9785-CL-0222                03/2011 - Present
Sponsor:  Astellas Pharma Global Development, Inc.
Title:  A Randomized, Double Blind, Phase II, Efficacy and Safety Study of MVD3100 (ASP9785) vs. Bicalutamide in Castrate Men with Metastatic Prostate Cancer

Purpose of Study
To determine the progression free survival, safety of treatment, prostate specific antigen (PSA) response and quality of life of MDV3100 as compared to bicalutamide.

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.

List of Completed Trials for Prostate Cancer

Protocol Number:  FE200486 CS35                       00/2009 - 04/2011
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 

Protocol Number:  REDEEM-AVO105948           08/2006 - 07/2010
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.
 
Protocol Number:  AMGEN 20050103                 05/2006 - 02/2010
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.

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:
Lisa Bennett, RN or Michelle Utrera (336) 274-1114 ext. 5322
E-mail address: research@allianceurology.com