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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
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Supportive care, Treatment | Closed | 65 and under | MDA-ID-01304
NCT00080808 |
Special Category:
SPORE trial 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.
Entry Criteria Disease Characteristics:
- Diagnosis of clinically localized adenocarcinoma of the prostate
- 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy 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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal Other - No peripheral neuropathy that would preclude procurement of a sural nerve graft
- No significant psychiatric illness
- No demonstrable vasculogenic source of impotence
Expected Enrollment 200A total of 200 patients (120 for arm I and 80 for arm II) will be accrued for this study. Outcomes Primary Outcome(s)Potency rate at 2 years after surgery
Secondary Outcome(s)Time to first spontaneous erection
Quality of nocturnal erection as objectively measured by the Rigiscan
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.
Trial Contact Information
Trial Lead Organizations M. D. Anderson Cancer Center at University of Texas | | | | Christopher Wood, MD, Protocol chair | | | Ph: 713-792-3250; 800-392-1611 |
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| Registry Information | | | 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 | | | Trial Start Date | | 2001-08-28 | | | Registered in ClinicalTrials.gov | | NCT00080808 | | | Date Submitted to PDQ | | 2003-11-11 | | | Information Last Verified | | 2006-08-07 | | | NCI Grant/Contract Number | | CA16672, CA90270 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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