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

NCT00080808 | Completed Phase 2

• 5 other identifiers: ID01-304P50CA090270P30CA016672MDA-ID-01304CDR0000355366
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Potency rate at 2 years after surgery

  2 years

Study Arms (2)

Arm I

ACTIVE COMPARATOR

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

Drug: Alprostadil (E1); Drug: Papaverine; Drug: Phentolamine mesylate; Drug: Sildenafil citrate; Procedure: conventional surgery

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.

Drug: Alprostadil (E1); Drug: Papaverine; Drug: Phentolamine mesylate; Drug: Sildenafil citrate; Procedure: conventional surgery

Interventions

Alprostadil (E1) DRUG

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

Also known as: Prostaglandin E1, PGE1

Arm I; Arm II (No sural nerve grafting)

Papaverine DRUG

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

Also known as: Paverine Injection, Papaverine Hydrochloride Injection

Arm I; Arm II (No sural nerve grafting)

Phentolamine mesylate DRUG

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

Arm I; Arm II (No sural nerve grafting)

Sildenafil citrate DRUG

Oral sildenafil as needed

Also known as: Viagra

Arm I; Arm II (No sural nerve grafting)

conventional surgery PROCEDURE

Unilateral cavernous nerve sparing radical retropubic prostatectomy

Also known as: prostatectomy

Arm I; Arm II (No sural nerve grafting)

Eligibility Criteria

• Age: Up to 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• 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.

  PMID: 18783876 RESULT

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms; Postoperative Complications; Sexual Dysfunction, Physiological; Infertility; Sexuality

Interventions

Alprostadil; methyl N-acetylsibirosaminide; Papaverine; Phentolamine; Sildenafil Citrate; Prostatectomy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Purines; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Christopher G. Wood, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: August 1, 2001
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2009
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)