Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080808
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2004-04-07
Brief Title:
Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000355366 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P50CA090270 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-ID-01304 | OTHER | None | None |