Prostate Cancer Clinical Trial
Official title:
Erectile Dysfunction Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer
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.
PRIMARY OBJECTIVES:
I. To determine the rate of erectile function (defined as the ability to achieve and maintain
an erection sufficient for intercourse without the use of pharmacological assistance) at 1
year post-operatively in men undergoing BNS-RAP without the use of post-operative maintenance
pharmacotherapy.
II. To describe whether early post-operative maintenance pharmacotherapy Viagra can improve
return of erectile function at 1 year post-operatively in patients undergoing BNS-RAP.
III. To describe if early post-operative maintenance pharmacotherapy Viagra can decrease the
time-to-return of erectile function in patients undergoing BNS-RAP.
SECONDARY OBJECTIVES:
I. To describe whether early post-operative maintenance pharmacotherapy MUSE can improve
return of erectile function at 1 year post-operatively in patients undergoing BNS-RAP.
II. To describe if early post-operative maintenance pharmacotherapy MUSE can decrease the
time-to-return of erectile function in patients undergoing BNS-RAP.
III. To compare sexual function quality of life in men undergoing early post-operative
maintenance pharmacotherapy to those without early post-operative maintenance
pharmacotherapy.
IV. To compare the rate of potency at 1, 3, 6, 9, 12, and 18 months in men using Viagra
versus MUSE for early post-operative maintenance pharmacotherapy.
V. To describe the dropout rate for MUSE maintenance pharmacotherapy secondary to urethral
pain in men using 2% Lidocaine lubricant.
VI. To describe if penile length is decreased following BNS-RAP. VII. To describe if penile
length at one year is different in men who have return of potency versus those with no return
of potency.
OUTLINE: Patients receive 2 doses of intraurethral alprostadil prior to undergoing bilateral
nerve-sparing robotic-assisted prostatectomy. Within 4 weeks after surgery, patients are
randomized to 1 of 3 treatment arms.
ARM I: Patients receive intraurethral alprostadil once daily for up to 9 months in the
absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of
oral sildenafil citrate at least 48 hours apart monthly for up to 18 months.
ARM II: Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least
48 hours apart monthly for 18 months.
ARM III: Patients receive oral sildenafil citrate once daily for up to 9 months in the
absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of
oral sildenafil citrate at least 48 hours apart monthly for up to 18 months.
After completion of study treatment, patients are followed periodically for up to 18 months.
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