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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090376
• Other study ID #: 0501-0202
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2004
• Last updated: November 6, 2008
• Start date: December 2003

Study information

• Verified date: November 2008
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 69 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Impotence
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• GPI 1485

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Carolinas Health Care System McKay Urology	Charlotte	North Carolina
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Henry Ford Health System, Vattikuti Institute for Urology	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Connecticut Surgical Group	Hartford	Connecticut
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Center for Urological Research	La Mesa	California
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	Connecticut Urological Research at Grove Hill	New Britain	Connecticut
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	NYU Urology Associates	New York	New York
United States	HOPE Research Institute, LLC	Phoenix	Arizona
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	PPS Clinical Research, St. Louis	St. Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	Symphony Neuro Development Company

Country where clinical trial is conducted

United States,