ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00544076
• Other study ID #: 04071
• Secondary ID: NCI-2009-01602CD
• Status: Terminated
• Phase: Phase 3
• Start date: January 2006
• Est. completion date: April 2012

Study information

• Verified date: December 2018
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Male Erectile Disorder
• Prostate Cancer
• Prostatic Neoplasms
• Stage I Prostate Cancer
• Stage II Prostate Cancer

Intervention

Drug:
• sildenafil citrate
Given orally
• alprostadil
Given intraurethrally

Procedure:
• robotic-assisted laparoscopic surgery
Undergo prostatectomy
• quality-of-life assessment
Ancillary studies

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Potency rates (ability to obtain an erection sufficient for penetration) without assistance in those patients receiving maintenance Viagra compared to non-pharmacology controls was compared at 12 months from start of treatment using the fisher's exact test	12 months following BNS-RAP
Secondary	Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra	Potency rates with or without assistance in the control group versus maintenance MUSE or maintenance Viagra were compared at each of 6 and 18 months	At 6 and 18 months
Secondary	SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups	Median and range of SHIM scores evaluated at 1, 3, 6, 9, 12, and 18 months. SHIMS-5 is the Sexual Health Inventory for Men, which includes 5 questions that are scored from 1 to 5 each. The total score is obtained by adding all five response scores, and can range from 5 to 25 when all 5 questions are answered. Questions that are left unanswered are scored as a 0, and can result in an overall score lower than 5 (as low as 0). Higher scores are more desirable. A Score of 22-25 = no ED, 17-21=Mild ED, 12-16=Mild to moderate ED, 8-11=Moderate ED, and 5-7 =Severe ED (ED=Erectile Dysfunction). There are no sub-scale scores within this questionnaire.	At 1, 3, 6, 9, 12, and 18 months
Secondary	Penile Length	measurement of penile length in centimeters	At pre-treatment and 18 months