Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00080808

Purpose

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	Intervention	Phase
Prostate Cancer	Drug: Alprostadil (E1) Drug: Papaverine Drug: Phentolamine mesylate Drug: Sildenafil citrate Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Erectile Dysfunction Prostate Cancer Rehabilitation

Drug Information available for: Phentolamine Papaverine Papaverine hydrochloride Phentolamine mesylate Sildenafil Sildenafil citrate Alprostadil

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Potency rate at 2 years after surgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	111
Study Start Date:	August 2001
Study Completion Date:	July 2009
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm I Patients undergo unilateral cavernous nerve-sparing radical prostatectomy with unilateral autologous interposition sural nerve grafting.	Drug: Alprostadil (E1) Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly Other Names: Prostaglandin E1 PGE1 Drug: Papaverine Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly Other Names: Paverine Injection Papaverine Hydrochloride Injection 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
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.	Drug: Alprostadil (E1) Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly Other Names: Prostaglandin E1 PGE1 Drug: Papaverine Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly Other Names: Paverine Injection Papaverine Hydrochloride Injection 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

Arms

Assigned Interventions

Active Comparator: Arm I

Patients undergo unilateral cavernous nerve-sparing radical prostatectomy with unilateral autologous interposition sural nerve grafting.

Drug: Alprostadil (E1)

Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly

Other Names:

Prostaglandin E1
PGE1

Drug: Papaverine

Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly

Other Names:

Paverine Injection
Papaverine Hydrochloride Injection

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

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.

Drug: Alprostadil (E1)

Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly

Other Names:

Prostaglandin E1
PGE1

Drug: Papaverine

Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly

Other Names:

Paverine Injection
Papaverine Hydrochloride Injection

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

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.

Eligibility

Ages Eligible for Study:	up to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080808

Locations

United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Christopher G. Wood, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

UT MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2008 Sep 2.

Responsible Party:	Christopher Wood, M.D. / Associate Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00080808 History of Changes
Other Study ID Numbers:	ID01-304, P50CA090270, P30CA016672, MDA-ID-01304, CDR0000355366
Study First Received:	April 7, 2004
Last Updated:	August 18, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

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
papaverine
phentolamine
Nerve-sparing radical prostatectomy
nerve grafting

Additional relevant MeSH terms:

Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Alprostadil
Sildenafil
Papaverine

Phentolamine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists

ClinicalTrials.gov processed this record on February 12, 2012