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

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.

• 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.

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

• No prior androgen deprivation therapy (e.g., luteinizing hormone-releasing hormone agonists or antiandrogens)

Radiotherapy

• No prior pelvic irradiation

Surgery

• See Disease Characteristics

Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030,  United States; Recruiting

Study chairs or principal investigators

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

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