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

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Sildenafil citrate; Drug: Papaverine; Drug: Alprostadil (E1); Drug: Phentolamine mesylate; Procedure: conventional surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00080808

P30CA016672 (U.S. NIH Grant/Contract)

CDR0000355366 (Registry Identifier)

MDA-ID-01304 (Other Identifier)

P50CA090270 (U.S. NIH Grant/Contract)

ID01-304

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 111 patients

Sex: Male

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 </= 65 years of age at the time of study enrollment.
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:

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

111 participants in 2 patient groups

Arm I

Active Comparator group

Description:

Patients undergo unilateral cavernous nerve-sparing radical prostatectomy with unilateral autologous interposition sural nerve grafting.

Treatment:

Procedure: conventional surgery

Drug: Phentolamine mesylate

Drug: Alprostadil (E1)

Drug: Papaverine

Drug: Sildenafil citrate

Arm II (No sural nerve grafting)

Active Comparator group

Description:

Patients undergo unilateral cavernous nerve-sparing radical prostatectomy (without sural nerve grafting) and erectile dysfunction rehabilitation as in arm I.

Treatment:

Procedure: conventional surgery

Drug: Phentolamine mesylate

Drug: Alprostadil (E1)

Drug: Papaverine

Drug: Sildenafil citrate