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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


Phase 2
N/A
65 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.


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
4. Patient must have no peripheral neuropathy precluding procurement of a sural nerve
graft

5. Patient must have no significant psychiatric illness or demonstrable vasculogenic
source of impotence.

6. No prior history of pelvic irradiation or androgen deprivation therapy (LHRH agonists
or anti-androgens)

Exclusion Criteria:

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Potency rate at 2 years after surgery

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Christopher G. Wood, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID01-304

NCT ID:

NCT00080808

Start Date:

August 2001

Completion Date:

July 2009

Related Keywords:

  • Prostate Cancer
  • perioperative/postoperative complications
  • sexual dysfunction and infertility
  • sexuality and reproductive issues
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • prostaglandin E1
  • papaverine
  • phentolamine
  • Nerve-sparing radical prostatectomy
  • nerve grafting
  • Prostatic Neoplasms
  • Erectile Dysfunction

Name

Location

M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030