ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
NCT00544076 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2019-01-02
Summary
RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone prostatectomy for prostate cancer to recover from erectile dysfunction.
PURPOSE: This randomized clinical trial is studying giving sildenafil together with alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical prostatectomy for nonmetastatic prostate cancer.
Conditions
- Prostate Cancer
- Male Erectile Disorder
- Stage I Prostate Cancer
- Stage II Prostate Cancer
Interventions
- DRUG
-
sildenafil citrate
Given orally
- DRUG
-
alprostadil
Given intraurethrally
- PROCEDURE
-
robotic-assisted laparoscopic surgery
Undergo prostatectomy
- PROCEDURE
-
quality-of-life assessment
Ancillary studies
- OTHER
-
questionnaire administration
Ancillary studies
Sponsors & Collaborators
-
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Laura Crocitto · City of Hope Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-01-31
- Primary Completion
- 2012-04-30
- Completion
- 2012-04-30
Countries
- United States
Study Locations
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