Spots Global Cancer Trial Database for Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy
Official Title: Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 3 Arm, 12-Month Study to Evaluate the Effects of GPI 1485 on Erectile Function in Patients Undergoing Bilateral Nerve-Sparing Radical Retropubic Prostatectomy for Prostatic Carcinoma
Study ID: NCT00090376
Interventions
Study Description
Brief Summary: In this phase II study, an investigative (not approved by the FDA) drug called GPI 1485 is being assessed to see if it can help preserve erectile function after prostatectomy.
Detailed Description: This drug has been tested in animals, and was shown to protect nerves from damage and to regrow damaged nerves in these animal studies. Participants will receive either GPI 1485 or a placebo (inactive pill). Participants will begin study medication 3 full days prior to their scheduled surgery. GPI 1485 will be supplied as an oral tablet formulation to men who are candidates for bilateral nerve-sparing prostatectomies. Participants randomly assigned to receive GPI 1485 will be required to take four tablets four times a day by mouth. GPI 1485 matching placebo will also be supplied as an oral tablet formulation. Participants randomly assigned to placebo will be required to take 4 placebo tablets four times a day by mouth. Viagra® will be supplied as oral tablets beginning 1 month post-surgery. Patients can begin Viagra® 1 month post-surgery and may continue use until the end of the study, as needed. The duration of this study is 12 months which includes 5 office visits to your doctor in addition to the surgery day. During this study you will also have other clinical evaluations including a physical exam, blood work, ECG (tracing of your heart rhythm) and urinalysis. Participants enrolled in this study will also carry a handheld diary that is loaded with special protocol-specific software, which will be referred to as the patient experience diary (PED). Over the duration of this study, participants will complete their questionnaires and answer questions about their medication compliance in the electronic PED.
Eligibility
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
HOPE Research Institute, LLC, Phoenix, Arizona, United States
Center for Urological Research, La Mesa, California, United States
Stanford University Medical Center, Stanford, California, United States
Connecticut Surgical Group, Hartford, Connecticut, United States
Connecticut Urological Research at Grove Hill, New Britain, Connecticut, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Henry Ford Health System, Vattikuti Institute for Urology, Detroit, Michigan, United States
Washington University School of Medicine, St. Louis, Missouri, United States
PPS Clinical Research, St. Louis, St. Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
NYU Urology Associates, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Columbia University, New York, New York, United States
Carolinas Health Care System McKay Urology, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
Urological Associates of Lancaster, Ltd., Lancaster, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Vanderbilt Medical Center, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Contact Details
Name: Antonella Favit-Van Pelt, MD, PhD
Affiliation: Eisai Inc.
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
