Clinical trial NCT00544076: ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
Official title: Erectile Dysfunction Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Male Erectile Disorder
Stage I Prostate Cancer
Stage II Prostate Cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2007-10-16
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

* All patients undergoing BNS-RAP for prostate cancer will be asked to participate
* Ability to achieve erections sufficient for intercourse prior to surgery and an SHIMS-5 score of \>= 22
* Must maintain follow up care at COH for visits 1, 3, 6, 9, 12, and 18 months post surgery
* Participants willing to participate on study for a minimum of 18 months
* Consented participant on the Prostate database study (protocol 00149)
* Patients must have a clinical stage of \< T3
* Gleason score \< 8 on post-operative pathological sample prior to randomization

Exclusion Criteria

* Metastatic disease
* Coronary artery disease on nitrate therapy (including oral sublingual nitrates)
* Unable to maintain follow up visits at COH at 1, 3, 6, 9, 12, and 18 months post-operatively
* Pathology diagnosis \>= pT3
* Prior hormonal treatment use for prostate cancer or low serum testosterone
* Allergy to prostaglandin PGE1, Lidocaine, or Viagra
* Gleason score \>= 8 on post-operative pathological sample prior to randomization
* Concomitant use of cytochrome P450 3AY inhibitors (cimetidine, erythromycin, ketoconazole, or protease inhibitors)
* SHIMS-5 score =\< 21

Primary outcomes:
measure: Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months
timeFrame: 12 months following BNS-RAP
Secondary outcomes:
measure: Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra
timeFrame: At 6 and 18 months
measure: SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups
timeFrame: At 1, 3, 6, 9, 12, and 18 months
measure: Penile Length
timeFrame: At pre-treatment and 18 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Laura Crocitto
role: PRINCIPAL_INVESTIGATOR
References: