Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate 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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Closed	65 and under	NCI	MDA-ID-01304 NCT00080808

Special Category: SPORE trial

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• Younger than 66 years old
• No previous antiandrogen therapy
• No previous radiation therapy to the pelvis
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups.

Patients in group one will undergo nerve-sparing radical prostatectomy with nerve grafting. Beginning 6 weeks after surgery, they will begin one or more standard therapies for erectile dysfunction that may continue for up to 2 years.

Patients in group two will undergo nerve-sparing radical prostatectomy alone followed by standard erectile dysfunction therapies as in group one.

Quality of life will be assessed and patients will be evaluated at least every 4 months for 2 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

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

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

Back to Top