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
- 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
- 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
- Compare the feasibility of these regimens in these patients.
- Compare quality of life and sexual satisfaction in patients treated with these
- Compare changes in penile erectile length and circumference in patients treated with
- 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
- 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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Potency rate at 2 years after surgery
Christopher G. Wood, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|