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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

NCT00080808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2012-07-30

No results posted yet for this study

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

Interventions

DRUG

Alprostadil (E1)

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

DRUG

Papaverine

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

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

PROCEDURE

conventional surgery

Unilateral cavernous nerve sparing radical retropubic prostatectomy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Christopher G. Wood, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2006-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00080808 on ClinicalTrials.gov