Completed

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

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What is being tested

Alprostadil (E1)

+ Papaverine

+ Phentolamine mesylate

DrugProcedure
Who is being recruted

Urogenital Diseases+11

+ Genital Diseases

+ Mental Disorders

Until 65 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 2
Interventional
Study Start: August 2001
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2001

Actual date on which the first participant was enrolled.

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.

Official TitleA Randomized Phase II Trial Evaluating the Importance of Early Erectile Dysfunction Rehabilitation and Unilateral Autologous Sural Nerve Sparing Radical Prostatectomy Clinically Localized Prostate Cancer 
NCT00080808
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

111 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Until 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesMental DisordersGenital Diseases, MaleGenital Neoplasms, MaleErectile DysfunctionNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsSexual Dysfunction, PhysiologicalUrogenital NeoplasmsSexual Dysfunctions, PsychologicalMale Urogenital Diseases

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:

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Active Comparator
Patients undergo unilateral cavernous nerve-sparing radical prostatectomy (without sural nerve grafting) and erectile dysfunction rehabilitation as in arm I.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

M.D. Anderson Cancer Center at University of Texas

Houston, United StatesSee the location
CompletedOne Study Center