Clinical Trial: Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
perioperative/postoperative complications
sexual dysfunction and infertility
sexuality and reproductive issues
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
 Drug: papaverine
 Drug: phentolamine
 Drug: prostaglandin E1
 Drug: sildenafil
 Procedure: complications of therapy assessment/management
 Procedure: conventional surgery
 Procedure: supportive care/therapy
 Procedure: surgery
Phase II

MedlinePlus related topics:  Prostate Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Randomized Study 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

Further Study Details: 

OBJECTIVES:

  • Compare the efficacy of erectile dysfunction rehabilitation and unilateral cavernous nerve-sparing radical prostatectomy with vs 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.

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

Ages Eligible for Study:  up to  65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of clinically localized adenocarcinoma of the prostate
  • T1-2, NX, M0 disease
  • Candidate for unilateral nerve-sparing radical retropubic prostatectomy
  • Gleason score ≤ 7 in the cores on the side to be spared
  • No discernable preoperative erectile dysfunction, defined as the ability to have successful penetration on at least 75% of attempts

PATIENT CHARACTERISTICS: Age

  • 65 and under

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No peripheral neuropathy that would preclude procurement of a sural nerve graft
  • No significant psychiatric illness
  • No demonstrable vasculogenic source of impotence

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

Radiotherapy

Surgery

  • See Disease Characteristics

Location and Contact Information


Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030,  United States; Recruiting
Christopher Wood, MD  713-792-3250 

Study chairs or principal investigators

Christopher Wood, MD,  Study Chair,  M.D. Anderson Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000355366; MDA-ID-01304; NCT00080808
Record last reviewed:  March 2004
Last Updated:  April 5, 2005
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00080808
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005