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

Completed · Phase 2

Conditions studied: Impotence, Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00090376

Run by

Eisai Inc.

People needed

240

Starts

2003-12-01

Last updated by the study team

2008-11-07

Who can join

Age: 40 and older, up to 69. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• HOPE Research Institute, LLC — Phoenix, Arizona, United States
• Center for Urological Research — La Mesa, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Connecticut Surgical Group — Hartford, Connecticut, United States
• Connecticut Urological Research at Grove Hill — New Britain, Connecticut, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System, Vattikuti Institute for Urology — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• PPS Clinical Research, St. Louis — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• NYU Urology Associates — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Columbia University — New York, New York, United States
• Carolinas Health Care System McKay Urology — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Urological Associates of Lancaster, Ltd. — Lancaster, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Vanderbilt Medical Center — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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