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Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy

Primary Purpose

Impotence, Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GPI 1485
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impotence focused on measuring Erectile Dysfunction, Impotence, Prostate Cancer, Prostatectomy

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • HOPE Research Institute, LLC
  • Center for Urological Research
  • Stanford University Medical Center
  • Connecticut Surgical Group
  • Connecticut Urological Research at Grove Hill
  • Tulane University Health Sciences Center
  • Johns Hopkins Hospital
  • University of Michigan
  • Henry Ford Health System, Vattikuti Institute for Urology
  • Washington University School of Medicine
  • PPS Clinical Research, St. Louis
  • Hackensack University Medical Center
  • NYU Urology Associates
  • Memorial Sloan-Kettering Cancer Center
  • Columbia University
  • Carolinas Health Care System McKay Urology
  • Duke University Medical Center
  • The Cleveland Clinic Foundation
  • Urological Associates of Lancaster, Ltd.
  • Carolina Urologic Research Center
  • Vanderbilt Medical Center
  • The University of Texas MD Anderson Cancer Center
  • The University of Texas Health Science Center at San Antonio
  • Virginia Mason Medical Center
  • Madigan Army Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 25, 2004
Last Updated
November 6, 2008
Sponsor
Eisai Inc.
Collaborators
Symphony Neuro Development Company
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1. Study Identification

Unique Protocol Identification Number
NCT00090376
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 Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Inc.
Collaborators
Symphony Neuro Development Company

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence, Prostate Cancer
Keywords
Erectile Dysfunction, Impotence, Prostate Cancer, Prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GPI 1485

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonella Favit-Van Pelt, MD, PhD
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
Facility Name
HOPE Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Center for Urological Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5118
Country
United States
Facility Name
Connecticut Surgical Group
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Connecticut Urological Research at Grove Hill
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052-1395
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0330
Country
United States
Facility Name
Henry Ford Health System, Vattikuti Institute for Urology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
PPS Clinical Research, St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
NYU Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Carolinas Health Care System McKay Urology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Urological Associates of Lancaster, Ltd.
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604-3200
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2765
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-1100
Country
United States

12. IPD Sharing Statement

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Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy

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