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:	National Cancer Institute (NCI)
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
Perioperative/Postoperative Complications Prostate Cancer Sexual Dysfunction and Infertility Sexuality and Reproductive Issues	Drug: alprostadil Drug: papaverine Drug: phentolamine mesylate Drug: sildenafil citrate Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control
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 Infertility Prostate Cancer Surgery

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

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Potency rate at 2 years after surgery

Secondary Outcome Measures:

Time to first spontaneous erection
Quality of nocturnal erection as objectively measured by the Rigiscan

Estimated Enrollment:	200
Study Start Date:	August 2001

Detailed Description:

OBJECTIVES:

Compare the efficacy of erectile dysfunction rehabilitation and unilateral cavernous nerve-sparing radical prostatectomy with vs 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

DISEASE CHARACTERISTICS:

Diagnosis of clinically localized adenocarcinoma of the prostate
- T1-2, NX, M0 disease
Candidate for unilateral nerve-sparing radical retropubic prostatectomy
- Gleason score ≤ 7 in the cores on the side to be spared
No discernable preoperative erectile dysfunction, defined as the ability to have successful penetration on at least 75% of attempts

PATIENT CHARACTERISTICS:

Age

65 and under

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No peripheral neuropathy that would preclude procurement of a sural nerve graft
No significant psychiatric illness
No demonstrable vasculogenic source of impotence

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

No prior androgen deprivation therapy (e.g., luteinizing hormone-releasing hormone agonists or antiandrogens)

Radiotherapy

No prior pelvic irradiation

Surgery

See Disease Characteristics

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

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.

Study ID Numbers:	CDR0000355366, MDA-ID-01304
Study First Received:	April 7, 2004
Last Updated:	October 31, 2009
ClinicalTrials.gov Identifier:	NCT00080808 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

perioperative/postoperative complications
sexual dysfunction and infertility
sexuality and reproductive issues

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:

Alprostadil
Infertility
Neurotransmitter Agents
Vasodilator Agents
Adrenergic Agents
Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Urogenital Neoplasms
Fibrinolytic Agents
Genital Diseases, Female
Fibrin Modulating Agents
Sexual Dysfunction, Physiological

Neoplasms by Site
Pathologic Processes
Mental Disorders
Therapeutic Uses
Sexual Dysfunctions, Psychological
Papaverine
Enzyme Inhibitors
Sildenafil
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Genital Diseases, Male
Sexual and Gender Disorders
Pharmacologic Actions
Phentolamine

ClinicalTrials.gov processed this record on November 25, 2009