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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA090270 | U.S. NIH Grant/Contract | View source | |
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-ID-01304 | Other Identifier | UT MD Anderson Cancer Center | |
| CDR0000355366 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | Patients undergo unilateral cavernous nerve-sparing radical prostatectomy with unilateral autologous interposition sural nerve grafting. |
|
| Arm II (No sural nerve grafting) | Active Comparator | Patients undergo unilateral cavernous nerve-sparing radical prostatectomy (without sural nerve grafting) and erectile dysfunction rehabilitation as in arm I. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprostadil (E1) | Drug | Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Potency rate at 2 years after surgery | 2 years |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher G. Wood, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18783876 | Result | Davis JW, Chang DW, Chevray P, Wang R, Shen Y, Wen S, Pettaway CA, Pisters LL, Swanson DA, Madsen LT, Huber N, Troncoso P, Babaian RJ, Wood CG. Randomized phase II trial evaluation of erectile function after attempted unilateral cavernous nerve-sparing retropubic radical prostatectomy with versus without unilateral sural nerve grafting for clinically localized prostate cancer. Eur Urol. 2009 May;55(5):1135-43. doi: 10.1016/j.eururo.2008.08.051. Epub 2008 Sep 2. |
| Label | URL |
|---|---|
| UT MD Anderson Cancer Center Website | View source |
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|
| Papaverine | Drug | Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly |
|
|
| Phentolamine mesylate | Drug | Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly |
|
| Sildenafil citrate | Drug | Oral sildenafil as needed |
|
|
| conventional surgery | Procedure | Unilateral cavernous nerve sparing radical retropubic prostatectomy |
|
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011183 | Postoperative Complications |
| D012735 | Sexual Dysfunction, Physiological |
| D007246 | Infertility |
| D019529 | Sexuality |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000527 | Alprostadil |
| C042762 | methyl N-acetylsibirosaminide |
| D010208 | Papaverine |
| D010646 | Phentolamine |
| D000068677 | Sildenafil Citrate |
| D011468 | Prostatectomy |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D053610 | Opiate Alkaloids |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D011687 | Purines |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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