Back to results4-aminopyridine Treatment for Nerve Injury From Radical Retro-Pubic Prostatectomy
Primary Purpose
Prostate Disease
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
4-aminopyridine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Disease
Eligibility Criteria
Inclusion Criteria
- Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c), planning to undergo Robotic-Assisted Laparoscopic Bilateral Nerve sparing radical prostatectomy (NSRP)
- Prostate-specific antigen (PSA) levels less than 10 ng/ml, with biopsy-proven prostate cancer, for whom postoperative adjuvant therapy (e.g. radiation or androgen deprivation therapy) is not expected to be needed
- Ages 45-75
- An International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening
- Is sexually active for at least 6 months with sexual activity within 6 weeks preceding prostate biopsy or surgery.
- Willingness to participate and able to provide informed consent
Exclusion Criteria
- Planned adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer (stage T3 or greater), positive lymph nodes or positive surgical margins.
- History of prior phosphodiesterase inhibitor use
- Neo-adjuvant therapy prior to NSRP
- History of recurrent prostate cancer
- History of seizures, multiple sclerosis, stroke or any other diagnosed neurological disorder
- History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater)
- History of known hypersensitivity to AMPYRA® or 4-aminopyridine
- Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery.
- Renal impairment based on calculated GFR (GFR<60 mL/min)
- Use of any other aminopyridine medications for any other indication
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
4-aminopyridine
Placebo
Arm Description
Participants with recent prostatectomies receiving 4-aminopyridine
Participants with recent prostatectomies receiving placebo
Outcomes
Primary Outcome Measures
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Secondary Outcome Measures
the time point at which the highest number of subjects reporting normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal erectile dysfunction
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
percentage of participants with normal urinary continence
Incontinence will be assessed using the Michigan Incontinence Symptom Index. The Michigan Incontinence Symptom Index ranges from 0-40 with higher scores indicating more problems with urinary incontinence.
Full Information
NCT ID
NCT03658408
First Posted
August 31, 2018
Last Updated
October 31, 2018
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT03658408
Brief Title
4-aminopyridine Treatment for Nerve Injury From Radical Retro-Pubic Prostatectomy
Official Title
4-aminopyridine Treatment for Nerve Injury From Radical Retro-Pubic Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
This record should not have been created for this study. It is under another sponsor's account.
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to see if the study drug 4-aminopyridine (4-AP) can help speed up the recovery of peripheral nerve injury after prostatectomy. 4-AP is a potassium channel blocker used to improve walking in multiple sclerosis patients. Investigators will measure the effect that 4-AP may have on the recovery of sexual function and urinary incontinence after prostatectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4-aminopyridine
Arm Type
Experimental
Arm Description
Participants with recent prostatectomies receiving 4-aminopyridine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants with recent prostatectomies receiving placebo
Intervention Type
Drug
Intervention Name(s)
4-aminopyridine
Intervention Description
Oral tablet of 2.5 mg given 4 times a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
2.5 mg sugar pill given orally 4 times a day
Primary Outcome Measure Information:
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
the time point at which the highest number of subjects reporting normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
baseline to month 12
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 3
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 4
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 6
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 8
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 10
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 12
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 14
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 16
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 18
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 20
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 22
Title
percentage of participants with normal erectile dysfunction
Description
Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time Frame
week 24
Title
percentage of participants with normal urinary continence
Description
Incontinence will be assessed using the Michigan Incontinence Symptom Index. The Michigan Incontinence Symptom Index ranges from 0-40 with higher scores indicating more problems with urinary incontinence.
Time Frame
2 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participants must have prostate disease (only males)
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c), planning to undergo Robotic-Assisted Laparoscopic Bilateral Nerve sparing radical prostatectomy (NSRP)
Prostate-specific antigen (PSA) levels less than 10 ng/ml, with biopsy-proven prostate cancer, for whom postoperative adjuvant therapy (e.g. radiation or androgen deprivation therapy) is not expected to be needed
Ages 45-75
An International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening
Is sexually active for at least 6 months with sexual activity within 6 weeks preceding prostate biopsy or surgery.
Willingness to participate and able to provide informed consent
Exclusion Criteria
Planned adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer (stage T3 or greater), positive lymph nodes or positive surgical margins.
History of prior phosphodiesterase inhibitor use
Neo-adjuvant therapy prior to NSRP
History of recurrent prostate cancer
History of seizures, multiple sclerosis, stroke or any other diagnosed neurological disorder
History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater)
History of known hypersensitivity to AMPYRA® or 4-aminopyridine
Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery.
Renal impairment based on calculated GFR (GFR<60 mL/min)
Use of any other aminopyridine medications for any other indication
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
4-aminopyridine Treatment for Nerve Injury From Radical Retro-Pubic Prostatectomy
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