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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Impotence
• Intervention / Treatment: Drug: GPI 1485

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.

• Study Type: Interventional
• Enrollment: 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • HOPE Research Institute, LLC
  • California
    • La Mesa, California, United States, 91942
      • Center for Urological Research
    • Stanford, California, United States, 94305-5118
      • Stanford University Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Surgical Group
    • New Britain, Connecticut, United States, 06052-1395
      • Connecticut Urological Research at Grove Hill
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Health Sciences Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0330
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System, Vattikuti Institute for Urology
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • St. Louis, Missouri, United States, 63141
      • PPS Clinical Research, St. Louis
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10017
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10016
      • NYU Urology Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Health Care System McKay Urology
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604-3200
      • Urological Associates of Lancaster, Ltd.
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232-2765
      • Vanderbilt Medical Center
  • Texas
    • Houston, Texas, United States, 77030-4009
      • The University of Texas MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229-3900
      • The University of Texas Health Science Center at San Antonio
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Tacoma, Washington, United States, 98431-1100
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Clinical diagnosis of localized prostate carcinoma and scheduled to undergo curative surgical resection via bilateral nerve sparing procedure.

2. Localized prostate cancer is defined as:

   • Gleason score <=7 (<=3 + <=4)
   • PSA <=10 off of finasteride (Proscar®) and dutasteride (Avodart®)
   • <=T2a stage disease
3. Motivated males, 40 to 69 years of age inclusive, and in the opinion of the investigator, are currently in a monogamous, sexually active relationship.
4. Males that have erectile function (EF) (without the use of pharmacotherapy within 30 days prior to screening assessment).
5. 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.
6. Body Mass Index (BMI) within the 18-34.9 kg/m2 range.
7. Able to swallow whole tablets equivalent to capsule size 0.
8. Available for protocol-specified visits and procedures.
9. Informed written consent must be provided prior to any study-specific procedures.

Exclusion Criteria:

1. Recent history, within 6 months before screening, of drug or alcohol abuse.
2. History of peripheral neuropathy.
3. History of acute or chronic depression that in the opinion of the investigator may interfere with protocol-specified efficacy measurements.
4. History of diabetes that requires use of insulin or oral hypoglycemic agents, myocardial infarction, or cerebrovascular accident.
5. History of spinal trauma or surgery to the brain or spinal cord.
6. 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.
7. History of pelvic radiation therapy (external beam radiation or brachytherapy).
8. Concomitant use of hormonal therapy, vasodilators (nitrates), dutasteride (Avodart®) or finasteride (Proscar®) within the 30 days prior to biopsy and throughout the study.
9. 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.
10. Previous exposure to GPI 1485 (previously AMG-474-00).
11. 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.
12. Any contraindication to Viagra® use
13. Unable to stop the use of inducers or inhibitors of cytochrome P450 (CYP) 3A4 from Baseline until the end of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: Symphony Neuro Development Company
• Investigators: Study Director: Antonella Favit-Van Pelt, MD, PhD, Eisai Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2003

Study Registration Dates

• First Submitted: August 25, 2004
• First Submitted That Met QC Criteria: August 27, 2004
• First Posted (Estimate): August 30, 2004

Study Record Updates

• Last Update Posted (Estimate): November 7, 2008
• Last Update Submitted That Met QC Criteria: November 6, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Prostate Cancer; Prostatectomy; Impotence
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Prostatic Neoplasms; Erectile Dysfunction
• Other Study ID Numbers: 0501-0202