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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00080808
First received: April 7, 2004
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  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 2

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:

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

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:

  1. 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
  2. Patient must have no discernable preoperative erectile dysfunction, defined as the ability to have successful penetration on at least 75% of attempts.
  3. Patient must be </= 65 years of age at the time of study enrollment.
  4. Patient must have no peripheral neuropathy precluding procurement of a sural nerve graft
  5. Patient must have no significant psychiatric illness or demonstrable vasculogenic source of impotence.
  6. 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:

Responsible Party: M.D. 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: July 27, 2012
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 May 19, 2013