Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00080808 |
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Recruitment Status :
Completed
First Posted : April 8, 2004
Last Update Posted : July 30, 2012
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: Alprostadil (E1) Drug: Papaverine Drug: Phentolamine mesylate Drug: Sildenafil citrate Procedure: conventional surgery | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 111 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| 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 |
| Study Start Date : | August 2001 |
| Actual Primary Completion Date : | July 2006 |
| Actual Study Completion Date : | July 2009 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm I
Patients undergo unilateral cavernous nerve-sparing radical prostatectomy with unilateral autologous interposition sural nerve grafting.
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Drug: Alprostadil (E1)
Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Other Names:
Drug: Papaverine Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Other Names:
Drug: Phentolamine mesylate Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly Drug: Sildenafil citrate Oral sildenafil as needed
Other Name: Viagra Procedure: conventional surgery Unilateral cavernous nerve sparing radical retropubic prostatectomy
Other Name: prostatectomy |
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Active Comparator: Arm II (No sural nerve grafting)
Patients undergo unilateral cavernous nerve-sparing radical prostatectomy (without sural nerve grafting) and erectile dysfunction rehabilitation as in arm I.
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Drug: Alprostadil (E1)
Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Other Names:
Drug: Papaverine Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Other Names:
Drug: Phentolamine mesylate Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly Drug: Sildenafil citrate Oral sildenafil as needed
Other Name: Viagra Procedure: conventional surgery Unilateral cavernous nerve sparing radical retropubic prostatectomy
Other Name: prostatectomy |
- Potency rate at 2 years after surgery [ Time Frame: 2 years ]
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| Ages Eligible for Study: | up to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Patient must have no discernable preoperative erectile dysfunction, defined as the ability to have successful penetration on at least 75% of attempts.
- Patient must be </= 65 years of age at the time of study enrollment.
- Patient must have no peripheral neuropathy precluding procurement of a sural nerve graft
- Patient must have no significant psychiatric illness or demonstrable vasculogenic source of impotence.
- No prior history of pelvic irradiation or androgen deprivation therapy (LHRH agonists or anti-androgens)
Exclusion Criteria:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080808
| United States, Texas | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Christopher G. Wood, MD | M.D. Anderson Cancer Center |
Additional Information:
Publications of Results:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00080808 History of Changes |
| Other Study ID Numbers: |
ID01-304 P50CA090270 ( U.S. NIH Grant/Contract ) P30CA016672 ( U.S. NIH Grant/Contract ) MDA-ID-01304 ( Other Identifier: UT MD Anderson Cancer Center ) CDR0000355366 ( Registry Identifier: NCI PDQ ) |
| First Posted: | April 8, 2004 Key Record Dates |
| Last Update Posted: | July 30, 2012 |
| Last Verified: | July 2012 |
Keywords provided by M.D. Anderson Cancer Center:
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papaverine perioperative/postoperative complications sexual dysfunction and infertility sexuality and reproductive issues adenocarcinoma of the prostate stage I prostate cancer |
stage II prostate cancer prostaglandin E1 phentolamine Nerve-sparing radical prostatectomy nerve grafting |
Additional relevant MeSH terms:
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Papaverine Prostatic Neoplasms Erectile Dysfunction Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders Sildenafil Citrate Alprostadil |
Phentolamine Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents Platelet Aggregation Inhibitors Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs Antihypertensive Agents |