Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Alprostadil (E1) (Drug); Papaverine (Drug); Phentolamine mesylate (Drug); Sildenafil citrate (Drug); conventional surgery (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s):
Christopher G. Wood, MD, Study Chair, Affiliation: M.D. Anderson Cancer Center
Summary
RATIONALE: Nerve-sparing radical prostatectomy with nerve grafting followed by standard
therapies for erectile dysfunction may be effective in helping patients with prostate cancer
improve sexual satisfaction and quality of life. It is not yet known whether erectile
dysfunction therapy and nerve-sparing prostatectomy are more effective with or without nerve
grafting.
PURPOSE: This randomized phase II trial is studying nerve grafting and standard therapy to
see how well they work compared to standard therapy alone in treating erectile dysfunction
in patients undergoing nerve-sparing radical prostatectomy for localized prostate cancer.
Clinical Details
Official title: A Randomized Phase II Trial Evaluating the Importance of Early Erectile Dysfunction Rehabilitation and Unilateral Autologous Sural Nerve Sparing Radical Prostatectomy Clinically Localized Prostate Cancer
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Potency rate at 2 years after surgery
Detailed description:
OBJECTIVES:
- Compare the efficacy of erectile dysfunction rehabilitation and unilateral cavernous
nerve-sparing radical prostatectomy with versus without unilateral autologous
interposition sural nerve grafting in patients with clinically localized prostate
cancer.
- Compare potency rates in patients treated with these regimens.
- Compare erection quality in patients treated with these regimens.
- Compare time to return of spontaneous erectile activity in patients treated with these
regimens.
- Compare the feasibility of these regimens in these patients.
- Compare quality of life and sexual satisfaction in patients treated with these
regimens.
- Compare changes in penile erectile length and circumference in patients treated with
these regimens.
- Compare the relative morbidity of patients treated with these regimens.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients undergo unilateral cavernous nerve-sparing radical prostatectomy with
unilateral autologous interposition sural nerve grafting.
Beginning 6 weeks after surgery, patients undergo erectile dysfunction rehabilitation
comprising any of the following: oral sildenafil (as occasion requires), use of vacuum
erection device over 10 minutes once daily, intracavernous Triplemix (prostaglandin E1,
papaverine, and phentolamine) injected twice weekly, or MUSE (suppository in urethra for
erections) therapy. Erectile dysfunction rehabilitation may continue for up to 2 years or
until return of adequate spontaneous erectile activity.
- Arm II: Patients undergo unilateral cavernous nerve-sparing radical prostatectomy
(without sural nerve grafting) and erectile dysfunction rehabilitation as in arm I.
In both arms, treatment continues in the absence of unacceptable toxicity.
Quality of life and sexual history are assessed at baseline, at 6 weeks postoperatively, at
4, 8, 12, and 16 months, and then every 4 months for 2 years or until return of spontaneous
erectile activity.
Patients are followed every 4 months for 2 years.
PROJECTED ACCRUAL: A total of 200 patients (120 for arm I and 80 for arm II) will be accrued
for this study.
Eligibility
Minimum age: N/A.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
1. Patient must be a candidate for a unilateral nerve sparing radical retropubic
prostatectomy. a) Gleason score 7 or less in the cores on the side to be spared
2. Patient must have no discernable preoperative erectile dysfunction, defined as the
ability to have successful penetration on at least 75% of attempts.
3. Patient must be
Locations and Contacts
M.D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database UT MD Anderson Cancer Center Website
Starting date: August 2001
Last updated: July 27, 2012
|
