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

Condition(s) targeted: Perioperative/Postoperative Complications; Prostate Cancer; Sexual Dysfunction and Infertility; Sexuality and Reproductive Issues

Intervention: alprostadil (Drug); papaverine (Drug); phentolamine mesylate (Drug); sildenafil citrate (Drug); conventional surgery (Procedure)

Phase: Phase 2

Status: Active, not recruiting

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

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.

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: Supportive Care, Randomized, Open Label, Active Control

Primary outcome: Potency rate at 2 years after surgery

Secondary outcome:

Time to first spontaneous erection

Quality of nocturnal erection as objectively measured by the Rigiscan

Detailed description: 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.

- 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.

Minimum age: N/A. Maximum age: 65 Years. Gender(s): Male.

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

M.D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States

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

Starting date: August 2001
Last updated: May 23, 2008