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
Alprostadil (E1)
+ Papaverine
+ Phentolamine mesylate
Urogenital Diseases+11
+ Genital Diseases
+ Mental Disorders
Supportive Care Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.111 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy 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