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. 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.

Condition	Treatment or Intervention	Phase
Impotence Prostate Cancer	Drug: GPI 1485	Phase II

Further Study Details: 

Expected Total Enrollment:  240

Ages Eligible for Study:  40 Years   -   69 Years,  Genders Eligible for Study:  Male

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.

Arizona
      HOPE Research Institute, LLC, Phoenix,  Arizona,  85032,  United States; Recruiting
California
      Center for Urological Research, La Mesa,  California,  91942,  United States; Not yet recruiting
      Stanford University Medical Center, Stanford,  California,  94305-5118,  United States; Recruiting
Connecticut
      Connecticut Urological Research at Grove Hill, New Britain,  Connecticut,  06052-1395,  United States; Not yet recruiting
      Connecticut Surgical Group, Hartford,  Connecticut,  06106,  United States; Not yet recruiting
Louisiana
      Tulane University Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Not yet recruiting
Maryland
      Johns Hopkins Hospital, Baltimore,  Maryland,  21287,  United States; Recruiting
Michigan
      University of Michigan, Ann Arbor,  Michigan,  48109-0330,  United States; Recruiting
      Henry Ford Health System, Vattikuti Institute for Urology, Detroit,  Michigan,  48202,  United States; Not yet recruiting
Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States; Recruiting
      PPS Clinical Research, St. Louis, St. Louis,  Missouri,  63141,  United States; Recruiting
New Jersey
      Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States; Recruiting
New York
      NYU Urology Associates, New York,  New York,  10016,  United States; Recruiting
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10017,  United States; Recruiting
      Columbia University, New York,  New York,  10032,  United States; Not yet recruiting
North Carolina
      Carolinas Health Care System McKay Urology, Charlotte,  North Carolina,  28204,  United States; Recruiting
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      The Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Recruiting
Pennsylvania
      Urological Associates of Lancaster, Ltd., Lancaster,  Pennsylvania,  17604-3200,  United States; Recruiting
South Carolina
      Carolina Urologic Research Center, Myrtle Beach,  South Carolina,  29572,  United States; Recruiting
Tennessee
      Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2765,  United States; Recruiting
Texas
      The University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229-3900,  United States; Recruiting
      The University of Texas MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States; Recruiting
Washington
      Virginia Mason Medical Center, Seattle,  Washington,  98101,  United States; Not yet recruiting
      Madigan Army Medical Center, Tacoma,  Washington,  98431-1100,  United States; Recruiting

Study ID Numbers:  0501-0202
Record last reviewed:  December 2004
Last Updated:  December 13, 2004
Record first received:  August 25, 2004
ClinicalTrials.gov Identifier:  NCT00090376
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08