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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00090376
Recruitment Status : Completed
First Posted : August 30, 2004
Last Update Posted : November 7, 2008
Symphony Neuro Development Company
Information provided by:
Eisai Inc.

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.

Condition or disease Intervention/treatment Phase
Impotence Prostate Cancer Drug: GPI 1485 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2003

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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00090376

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Sponsors and Collaborators
Eisai Inc.
Symphony Neuro Development Company
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Study Director: Antonella Favit-Van Pelt, MD, PhD Eisai Inc.

Layout table for additonal information Identifier: NCT00090376     History of Changes
Other Study ID Numbers: 0501-0202
First Posted: August 30, 2004    Key Record Dates
Last Update Posted: November 7, 2008
Last Verified: November 2008

Keywords provided by Eisai Inc.:
Erectile Dysfunction
Prostate Cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders