ED Recovery in Men Age

Status:	Terminated
Conditions:	Prostate Cancer, Cancer, Cancer, Cancer, Erectile Dysfunction
Therapuetic Areas:	Nephrology / Urology, Oncology
Healthy:	No
Age Range:	18 - 65
Updated:	1/3/2019
Start Date:	January 2006
End Date:	April 2012

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.

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