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

• Sponsor: City of Hope Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00544076
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 3
• Actual Duration (Months): 75
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Male Erectile Disorder; Stage I Prostate Cancer; Stage II Prostate Cancer	Drug: sildenafil citrate; Drug: alprostadil; Procedure: robotic-assisted laparoscopic surgery; Procedure: quality-of-life assessment; Other: questionnaire administration	Phase 3

Detailed Description

PRIMARY OBJECTIVES:

1. 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.

2. 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.

3. 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:

1. 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.

2. To describe if early post-operative maintenance pharmacotherapy MUSE can decrease the time-to-return of erectile function in patients undergoing BNS-RAP.

3. To compare sexual function quality of life in men undergoing early post-operative maintenance pharmacotherapy to those without early post-operative maintenance pharmacotherapy.

4. 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.

5. To describe the dropout rate for MUSE maintenance pharmacotherapy secondary to urethral pain in men using 2% Lidocaine lubricant.

6. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Erectile Dysfunction Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer
• Actual Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sildenafil Citrate/Mo+Aprostadil/day 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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.	Drug: sildenafil citrate; Given orally; Other Names: Viagra ; Drug: alprostadil; Given intraurethrally; Other Names: Caverject MUSE PGE1 prostaglandin E1 ; Procedure: robotic-assisted laparoscopic surgery; Undergo prostatectomy; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment ; Other: questionnaire administration; Ancillary studies
Active Comparator: Sildenafil Citrate Monthly Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.	Drug: sildenafil citrate; Given orally; Other Names: Viagra ; Procedure: robotic-assisted laparoscopic surgery; Undergo prostatectomy; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment ; Other: questionnaire administration; Ancillary studies
Experimental: Daily Sildenafil Citrate 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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.	Drug: sildenafil citrate; Given orally; Other Names: Viagra ; Procedure: robotic-assisted laparoscopic surgery; Undergo prostatectomy; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment ; Other: questionnaire administration; Ancillary studies

Outcome Measures

Primary Outcome Measures

1. 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 [12 months following BNS-RAP]

   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

Secondary Outcome Measures

1. Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra [At 6 and 18 months]

   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

2. SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups [At 1, 3, 6, 9, 12, and 18 months]

   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.

3. Penile Length [At pre-treatment and 18 months]

   measurement of penile length in centimeters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010

Sponsors and Collaborators

• City of Hope Medical Center

Investigators

• Principal Investigator: Laura Crocitto, City of Hope Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: City of Hope Medical Center
• ClinicalTrials.gov Identifier: NCT00544076
• Other Study ID Numbers: 04071; NCI-2009-01602; CDR0000570272
• First Posted: Oct 16, 2007
• Last Update Posted: Jan 2, 2019
• Last Verified: Dec 1, 2018

• Additional relevant MeSH terms: Prostatic Neoplasms; Erectile Dysfunction; Sildenafil Citrate; Alprostadil

Study Results

Participant Flow

Recruitment Details	10 patients were not randomized, for the following reasons: ineligible upon surgery - 4 patients patient withdrew or not returning to COH - 2 patients did not have BNS procedure -- 2 patients (5) deemed to have sensitivity to MUSE -- 2 patients

Arm/Group Title	Sildenafil Citrate/Mo+Aprostadil/Day	Sildenafil Citrate Monthly	Daily Sildenafil Citrate
Arm/Group Description	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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally alprostadil: Given intraurethrally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	P atients 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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
Period Title: Overall Study
STARTED	34	35	31
COMPLETED	17	19	20
NOT COMPLETED	17	16	11

Baseline Characteristics

Arm/Group Title	Sildenafil Citrate/Mo+Aprostadil/Day	Sildenafil Citrate Monthly	Sildenafil Citrate Monthly Daily Sildenafil Citrate	Total
Arm/Group Description	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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally alprostadil: Given intraurethrally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Total of all reporting groups
Overall Participants	34	35	31	100
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	58	58	59	58
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	34 100%	35 100%	31 100%	100 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.9%	0 0%	0 0%	1 1%
Asian	0 0%	0 0%	1 3.2%	1 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	2 5.9%	2 5.7%	3 9.7%	7 7%
White	31 91.2%	32 91.4%	25 80.6%	88 88%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 2.9%	2 6.5%	3 3%
Region of Enrollment (Count of Participants)
United States	34 100%	35 100%	31 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	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
Description	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
Time Frame	12 months following BNS-RAP

Outcome Measure Data

Analysis Population Description

These are the patients who remained on treatment for the duration of the 12 months and were evaluable at that time point.

Arm/Group Title	Sildenafil Citrate/Mo+Aprostadil/Day	Sildenafil Citrate Monthly	Daily Sildenafil Citrate
Arm/Group Description	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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally alprostadil: Given intraurethrally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
Measure Participants	17	19	20
Count of Participants [Participants]	13 38.2%	16 45.7%	16 51.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sildenafil Citrate/Mo+Aprostadil/Day, Sildenafil Citrate Monthly, Daily Sildenafil Citrate
	Comments
	Type of Statistical Test	Equivalence
	Comments	The equivalence margin that would be possible to detect (had the protocol reached intended accrual) was 20%,
Statistical Test of Hypothesis	p-Value	>0.1
	Comments	no adjustments were made.
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra
Description	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
Time Frame	At 6 and 18 months

Outcome Measure Data

Analysis Population Description

patients who were evaluated at 6 months, 18 months

Arm/Group Title	Sildenafil Citrate/Mo+Aprostadil/Day	Sildenafil Citrate Monthly	Daily Sildenafil Citrate
Arm/Group Description	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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally alprostadil: Given intraurethrally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	P atients 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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
Measure Participants	17	19	20
6 month potency	10 29.4%	11 31.4%	17 54.8%
18 month potency	14 41.2%	16 45.7%	15 48.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sildenafil Citrate/Mo+Aprostadil/Day, Sildenafil Citrate Monthly, Daily Sildenafil Citrate
	Comments	compare percentage of patients potent at 6 and 18 months across pairs of treatment arms (arm I vs arm II, arm I vs arm III, arm II vs arm III)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.1
	Comments	no adjustments done
	Method	Chi-squared
	Comments	no adjustments

3. Secondary Outcome

Title	SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups
Description	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.
Time Frame	At 1, 3, 6, 9, 12, and 18 months

Outcome Measure Data

Analysis Population Description

patients with shim scores at 1 month

Arm/Group Title	Sildenafil Citrate/Mo+Aprostadil/Day	Sildenafil Citrate Monthly	Daily Sildenafil Citrate
Arm/Group Description	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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally alprostadil: Given intraurethrally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	P atients 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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
Measure Participants	16	18	19
SHIM score 1 month	9.5	3	12
SHIM score 3 months	14	14	18
SHIM score 6 months	18	18.5	20
SHIM score 9 months	18.5	17.5	19
SHIM score 12 months	20	19	18
SHIM score 18 months	19.5	20	20.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sildenafil Citrate/Mo+Aprostadil/Day, Sildenafil Citrate Monthly, Daily Sildenafil Citrate
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.2
	Comments	no adjustments done.
	Method	ANOVA
	Comments

4. Secondary Outcome

Title	Penile Length
Description	measurement of penile length in centimeters
Time Frame	At pre-treatment and 18 months

Outcome Measure Data

Analysis Population Description

patients who were willing to have penile measurements taken at baseline

Arm/Group Title	Sildenafil Citrate/Mo+Aprostadil/Day	Sildenafil Citrate Monthly	Daily Sildenafil Citrate
Arm/Group Description	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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally alprostadil: Given intraurethrally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies	P atients 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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
Measure Participants	27	26	25
Baseline Penile Measurement	11	12	10.2
Month 18 Penile Measurement	12.5	11	12

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sildenafil Citrate/Mo+Aprostadil/Day, Sildenafil Citrate Monthly, Daily Sildenafil Citrate
	Comments	ANOVA test to compare difference of penile length (from baseline to month 18) across arms. calculations are underpowered, as study did not accrue or retain patients as intended, and many patients declined to have measurements taken.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments	no adjustments
	Method	ANOVA
	Comments	no adjustments for df
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.08
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	The time frame was over 1 year.
Adverse Event Reporting Description	The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
Arm/Group Title	Sildenafil Citrate/Mo+Aprostadil/Day		Sildenafil Citrate Monthly		Daily Sildenafil Citrate
Arm/Group Description	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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally alprostadil: Given intraurethrally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies		Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies		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. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments. sildenafil citrate: Given orally robotic-assisted laparoscopic surgery: Undergo prostatectomy quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies
All Cause Mortality
	Sildenafil Citrate/Mo+Aprostadil/Day		Sildenafil Citrate Monthly		Daily Sildenafil Citrate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)		0/31 (0%)
Serious Adverse Events
	Sildenafil Citrate/Mo+Aprostadil/Day		Sildenafil Citrate Monthly		Daily Sildenafil Citrate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Sildenafil Citrate/Mo+Aprostadil/Day		Sildenafil Citrate Monthly		Daily Sildenafil Citrate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/34 (70.6%)		19/35 (54.3%)		24/31 (77.4%)
Blood and lymphatic system disorders
Anemia	5/34 (14.7%)	5	7/35 (20%)	7	3/31 (9.7%)	3
Ear and labyrinth disorders
External ear inflammation	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
External ear pain	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Eye disorders
Cataract	1/34 (2.9%)	2	0/35 (0%)	0	0/31 (0%)	0
Eye disorders - Other, specify	2/34 (5.9%)	2	2/35 (5.7%)	6	0/31 (0%)	0
Eye pain	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Photophobia	0/34 (0%)	0	2/35 (5.7%)	5	4/31 (12.9%)	7
Gastrointestinal disorders
Abdominal distension	0/34 (0%)	0	1/35 (2.9%)	1	1/31 (3.2%)	1
Abdominal pain	2/34 (5.9%)	2	3/35 (8.6%)	3	1/31 (3.2%)	1
Cheilitis	1/34 (2.9%)	1	0/35 (0%)	0	0/31 (0%)	0
Diarrhea	0/34 (0%)	0	1/35 (2.9%)	1	1/31 (3.2%)	1
Dry mouth	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Dyspepsia	1/34 (2.9%)	3	1/35 (2.9%)	1	3/31 (9.7%)	10
Fecal incontinence	1/34 (2.9%)	1	0/35 (0%)	0	0/31 (0%)	0
Flatulence	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Gastrointestinal disorders - Other, specify	2/34 (5.9%)	2	1/35 (2.9%)	2	0/31 (0%)	0
Nausea	1/34 (2.9%)	2	2/35 (5.7%)	2	2/31 (6.5%)	2
Rectal hemorrhage	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Stomach pain	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Vomiting	0/34 (0%)	0	1/35 (2.9%)	1	1/31 (3.2%)	1
General disorders
Chills	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Edema trunk	2/34 (5.9%)	2	0/35 (0%)	0	0/31 (0%)	0
Fatigue	4/34 (11.8%)	4	2/35 (5.7%)	2	4/31 (12.9%)	5
General disorders and administration site conditions - Other, specify	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Pain	4/34 (11.8%)	7	1/35 (2.9%)	1	0/31 (0%)	0
Infections and infestations
Bladder infection	1/34 (2.9%)	1	0/35 (0%)	0	0/31 (0%)	0
Infections and infestations - Other, specify	1/34 (2.9%)	1	0/35 (0%)	0	0/31 (0%)	0
Injury, poisoning and procedural complications
Bladder anastomotic leak	1/34 (2.9%)	1	1/35 (2.9%)	1	0/31 (0%)	0
Bruising	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Wound dehiscence	1/34 (2.9%)	1	0/35 (0%)	0	1/31 (3.2%)	1
Investigations
Alanine aminotransferase increased	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Aspartate aminotransferase increased	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Blood bilirubin increased	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Cholesterol high	1/34 (2.9%)	1	0/35 (0%)	0	0/31 (0%)	0
Creatinine increased	0/34 (0%)	0	2/35 (5.7%)	2	1/31 (3.2%)	1
Lymphocyte count decreased	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Metabolism and nutrition disorders
Alkalosis	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Anorexia	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Hyperglycemia	1/34 (2.9%)	2	2/35 (5.7%)	2	0/31 (0%)	0
Hyperkalemia	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Hypertriglyceridemia	1/34 (2.9%)	1	0/35 (0%)	0	0/31 (0%)	0
Hyperuricemia	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Hypocalcemia	0/34 (0%)	0	2/35 (5.7%)	2	0/31 (0%)	0
Hypoglycemia	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Hypokalemia	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Hyponatremia	1/34 (2.9%)	1	0/35 (0%)	0	0/31 (0%)	0
Nervous system disorders
Dizziness	1/34 (2.9%)	1	0/35 (0%)	0	1/31 (3.2%)	1
Headache	5/34 (14.7%)	7	9/35 (25.7%)	29	10/31 (32.3%)	24
Memory impairment	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Nervous system disorders - Other, specify	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Sinus pain	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Syncope	1/34 (2.9%)	1	0/35 (0%)	0	0/31 (0%)	0
Psychiatric disorders
Insomnia	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	2
Libido decreased	1/34 (2.9%)	1	1/35 (2.9%)	1	2/31 (6.5%)	2
Renal and urinary disorders
Hematuria	4/34 (11.8%)	5	2/35 (5.7%)	2	1/31 (3.2%)	1
Proteinuria	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Renal and urinary disorders - Other, specify	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Urinary frequency	3/34 (8.8%)	3	1/35 (2.9%)	1	2/31 (6.5%)	6
Urinary incontinence	3/34 (8.8%)	3	3/35 (8.6%)	8	3/31 (9.7%)	8
Urinary retention	1/34 (2.9%)	1	1/35 (2.9%)	1	0/31 (0%)	0
Urinary tract obstruction	1/34 (2.9%)	1	1/35 (2.9%)	1	0/31 (0%)	0
Urinary tract pain	10/34 (29.4%)	17	2/35 (5.7%)	2	2/31 (6.5%)	2
Urine discoloration	1/34 (2.9%)	1	1/35 (2.9%)	1	1/31 (3.2%)	1
Reproductive system and breast disorders
Erectile dysfunction	1/34 (2.9%)	1	0/35 (0%)	0	0/31 (0%)	0
Pelvic pain	0/34 (0%)	0	2/35 (5.7%)	2	0/31 (0%)	0
Penile pain	8/34 (23.5%)	13	3/35 (8.6%)	3	2/31 (6.5%)	2
Reproductive system and breast disorders - Other, specify	1/34 (2.9%)	1	0/35 (0%)	0	2/31 (6.5%)	3
Scrotal pain	0/34 (0%)	0	1/35 (2.9%)	1	0/31 (0%)	0
Testicular pain	3/34 (8.8%)	4	0/35 (0%)	0	0/31 (0%)	0
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	1/34 (2.9%)	2	8/35 (22.9%)	27	5/31 (16.1%)	19
Cough	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Pharyngolaryngeal pain	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Skin and subcutaneous tissue disorders
Alopecia	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	2
Dry skin	0/34 (0%)	0	0/35 (0%)	0	1/31 (3.2%)	1
Rash maculo-papular	0/34 (0%)	0	2/35 (5.7%)	2	2/31 (6.5%)	2
Vascular disorders
Flushing	2/34 (5.9%)	4	8/35 (22.9%)	17	5/31 (16.1%)	12
Hypotension	1/34 (2.9%)	1	0/35 (0%)	0	0/31 (0%)	0

Limitations/Caveats

In addition to the fact that the trial was closed mid-way through accrual, nearly half of those that accrued dropped out prior to completing treatment. There is not enough power to make any conclusions regarding any of the aims set forth.

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.