Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy
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
1 other identifier
interventional
240
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 25, 2004
CompletedFirst Posted
Study publicly available on registry
August 30, 2004
CompletedNovember 7, 2008
November 1, 2008
August 25, 2004
November 6, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of localized prostate carcinoma and scheduled to undergo curative surgical resection via bilateral nerve sparing procedure.
- Localized prostate cancer is defined as:
- Gleason score \<=7 (\<=3 + \<=4)
- PSA \<=10 off of finasteride (Proscar®) and dutasteride (Avodart®)
- \<=T2a stage disease
- Motivated males, 40 to 69 years of age inclusive, and in the opinion of the investigator, are currently in a monogamous, sexually active relationship.
- Males that have erectile function (EF) (without the use of pharmacotherapy within 30 days prior to screening assessment).
- EF is defined as a score of \>=26 on the EF domain of the IIEF questionnaire based on patient experiences over the 4 weeks prior to biopsy.
- Body Mass Index (BMI) within the 18-34.9 kg/m2 range.
- Able to swallow whole tablets equivalent to capsule size 0.
- Available for protocol-specified visits and procedures.
- Informed written consent must be provided prior to any study-specific procedures.
You may not qualify if:
- Recent history, within 6 months before screening, of drug or alcohol abuse.
- History of peripheral neuropathy.
- History of acute or chronic depression that in the opinion of the investigator may interfere with protocol-specified efficacy measurements.
- History of diabetes that requires use of insulin or oral hypoglycemic agents, myocardial infarction, or cerebrovascular accident.
- History of spinal trauma or surgery to the brain or spinal cord.
- Any medical disability or laboratory abnormality (e.g., serum creatinine \> 2.0 mg/dL) that, in the opinion of the Investigator, may interfere with the protocol-specified safety and efficacy measurements, present an unacceptable risk to the patient's well-being, or compromise the patient's ability to provide informed consent.
- History of pelvic radiation therapy (external beam radiation or brachytherapy).
- Concomitant use of hormonal therapy, vasodilators (nitrates), dutasteride (Avodart®) or finasteride (Proscar®) within the 30 days prior to biopsy and throughout the study.
- Concomitant use of therapeutic agents to treat ED other than those specified in the protocol is not permitted starting at least 30 days prior to biopsy and continuing throughout the study.
- Previous exposure to GPI 1485 (previously AMG-474-00).
- Treatment with an investigational agent within the 30 days before screening or scheduled to receive an investigational agent other than that specified by this protocol during the course of this study.
- Any contraindication to Viagra® use
- Unable to stop the use of inducers or inhibitors of cytochrome P450 (CYP) 3A4 from Baseline until the end of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
- Symphony Neuro Development Companycollaborator
Study Sites (25)
HOPE Research Institute, LLC
Phoenix, Arizona, 85032, United States
Center for Urological Research
La Mesa, California, 91942, United States
Stanford University Medical Center
Stanford, California, 94305-5118, United States
Connecticut Surgical Group
Hartford, Connecticut, 06106, United States
Connecticut Urological Research at Grove Hill
New Britain, Connecticut, 06052-1395, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
University of Michigan
Ann Arbor, Michigan, 48109-0330, United States
Henry Ford Health System, Vattikuti Institute for Urology
Detroit, Michigan, 48202, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
PPS Clinical Research, St. Louis
St Louis, Missouri, 63141, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
NYU Urology Associates
New York, New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10017, United States
Columbia University
New York, New York, 10032, United States
Carolinas Health Care System McKay Urology
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Urological Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, 17604-3200, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37232-2765, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Madigan Army Medical Center
Tacoma, Washington, 98431-1100, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Antonella Favit-Van Pelt, MD, PhD
Eisai Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2004
First Posted
August 30, 2004
Study Start
December 1, 2003
Last Updated
November 7, 2008
Record last verified: 2008-11