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
Drug
Procedure
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, 2001Actual 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
Until 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Genital Diseases
Mental Disorders
Genital Diseases, Male
Genital Neoplasms, Male
Erectile Dysfunction
Neoplasms
Neoplasms by Site
Prostatic Diseases
Prostatic Neoplasms
Sexual Dysfunction, Physiological
Urogenital Neoplasms
Sexual Dysfunctions, Psychological
Male 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.

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

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

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

Oral sildenafil as needed

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

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

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

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

Oral sildenafil as needed

Unilateral cavernous nerve sparing radical retropubic prostatectomy
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 TexasHouston, United StatesSee the location
CompletedOne Study Center
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