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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


Phase 2
40 Years
69 Years
Not Enrolling
Male
Impotence, Prostate Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Antonella Favit-Van Pelt, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

0501-0202

NCT ID:

NCT00090376

Start Date:

December 2003

Completion Date:

Related Keywords:

  • Impotence
  • Prostate Cancer
  • Erectile Dysfunction
  • Impotence
  • Prostate Cancer
  • Prostatectomy
  • Prostatic Neoplasms
  • Erectile Dysfunction

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Stanford University Medical CenterStanford, California  94305-5408
Washington University School of MedicineSaint Louis, Missouri  63110
Virginia Mason Medical CenterSeattle, Washington  98111
Madigan Army Medical CenterTacoma, Washington  98431-5048
Hackensack University Medical CenterHackensack, New Jersey  07601
Columbia UniversityNew York, New York  10032-3784
Duke University Medical CenterDurham, North Carolina  27710
Center for Urological ResearchLa Mesa, California  91942
The Cleveland Clinic FoundationCleveland, Ohio  
Urological Associates of Lancaster, Ltd.Lancaster, Pennsylvania  17604
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
Connecticut Surgical GroupHartford, Connecticut  06106
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Connecticut Urological Research at Grove HillNew Britain, Connecticut  06052
The University of Texas Health Science Center at San AntonioSan Antonio, Texas  78229
HOPE Research Institute, LLCPhoenix, Arizona  85032
Johns Hopkins HospitalBaltimore, Maryland  21287
Henry Ford Health System, Vattikuti Institute for UrologyDetroit, Michigan  48202
PPS Clinical Research, St. LouisSt. Louis, Missouri  63141
NYU Urology AssociatesNew York, New York  10016
Carolinas Health Care System McKay UrologyCharlotte, North Carolina  28204
Vanderbilt Medical CenterNashville, Tennessee  37232-2765
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009