Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Sildenafil and Alprostadil in Treating Patients Undergoing Bilateral Nerve-Sparing Robotic-Assisted Prostatectomy for Nonmetastatic Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Active	18 to 65	NCI	CHNMC-04071 04071, NCT00544076

Objectives

Primary

1. To determine the rate of erectile function (defined as the ability to achieve and maintain an erection for intercourse without pharmacological assistance) at 1 year following bilateral nerve-sparing robotic-assisted prostatectomy (BNS-RAP) without postoperative maintenance pharmacotherapy in patients with nonmetastatic prostate cancer.
2. To describe whether early postoperative maintenance pharmacotherapy with sildenafil citrate can improve return of erectile function at 1 year postoperatively in these patients.
3. To describe if early postoperative maintenance pharmacotherapy with sildenafil citrate can decrease the time-to-return of erectile function in these patients.

Secondary

1. To describe whether early postoperative maintenance pharmacotherapy with alprostadil can improve return of erectile function at 1 year postoperatively in these patients.
2. To describe if early postoperative maintenance pharmacotherapy with alprostadil can decrease the time-to-return of erectile function in these patients.
3. To compare sexual function quality of life in patients undergoing early postoperative maintenance pharmacotherapy to those without early postoperative maintenance pharmacotherapy.
4. To compare the rate of potency at 1, 3, 6, 9, 12, and 18 months in patients using sildenafil citrate versus alprostadil for early postoperative maintenance pharmacotherapy.
5. To describe the dropout rate for alprostadil maintenance pharmacotherapy secondary to urethral pain in patients using 2% lidocaine lubricant.
6. To describe if penile length is decreased following BNS-RAP.
7. To describe if penile length at 1 year is different in patients who have return of potency versus those who have no return of potency.

Entry Criteria

Disease Characteristics:

• Diagnosis of prostate cancer
  • Stage T3 or less disease
  • Gleason score ≤ 8 based on final surgical pathological biopsy results
  • Nonmetastatic disease as confirmed by CT scan, bone scan, or lymph node biopsy



• Concurrently enrolled on the Prostate Database Study (protocol no. 00149) at the City of Hope National Medical Center



• Scheduled to undergo bilateral nerve-sparing robotic-assisted prostatectomy



• Was able to achieve erections sufficient for intercourse prior to surgery AND has an Erectile Dysfunction Penile Assessment (SHIMS-5) score ≥ 22

Prior/Concurrent Therapy:

• No concurrent nitrate therapy (including oral sublingual nitrates) for coronary artery disease
• No prior hormonal treatment for prostate cancer or low serum testosterone
• No concurrent cytochrome P450 3AY inhibitors (i.e., cimetidine, erythromycin, ketoconazole, or protease inhibitors)

Patient Characteristics:

• Willing to participate on study for 18 months
• Able to maintain follow-up care at the City of Hope National Medical Center for visits 1, 3, 6, 9, 12, and 18 months post surgery
• No allergy to the prostaglandin PGE1, lidocaine, or sildenafil citrate

Expected Enrollment

Outcomes

Potency (defined as ability to attain an erection sufficient for penetration) rates without assistance at 12 months after bilateral nerve-sparing robotic-assisted prostatectomy (BNS-RAP) in patients receiving maintenance sildenafil citrate

Potency rates at 12 months after BNS-RAP in patients receiving maintenance alprostadil
Potency rates with or without assistance at 1, 3, 6, 9, and 18 months after BNS-RAP
Erectile Dysfunction Penile Assessment (SHIMS-5) scores at 1, 3, 6, 9, and 18 months after BNS-RAP
Penile length at randomization and at 1, 3, 6, 9, and 18 months after BNS-RAP
Dropout rates in the alprostadil maintenance therapy group secondary to penile burning/pain after alprostadil usage

Outline

Patients receive 2 doses of intraurethral alprostadil prior to undergoing bilateral nerve-sparing robotic-assisted prostatectomy (BNS-RAP). Within 2 weeks after surgery, patients are randomized to 1 of 3 treatment arms. In arms I and III, treatment begins at the first postoperative visit.

• Arm I: Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of unacceptable toxicity. Patients also receive a set of 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months.



• Arm II: Patients receive a set of 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months.



• Arm III: Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of unacceptable toxicity. Patients also receive a set of 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months.

Patients undergo assessment of erectile dysfunction, penile length, rate of urinary incontinence, and sexual function quality of life at baseline (preoperatively) and periodically during study. Patients are also assessed using a self-reported diary that records daily maintenance therapy, nocturnal erections, pharmacotherapy for intercourse, and the results of pharmacotherapy usage (i.e., no erection, erection sufficient for penetration, or erection insufficient for intercourse).

After completion of study therapy, patient are followed periodically for up to 18 months.

Trial Contact Information

Trial Lead Organizations

City of Hope Comprehensive Cancer Center

Laura Crocitto, MD, Principal investigator		Ph: 626-256-4673 ext. 67100; 800-826-4673 Email: lcrocitto@coh.org

U.S.A.
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org

Registry Information
Official Title		Erectile Dysfunction Recovery in Men age </=65 Treated with Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer
Trial Start Date		2005-11-17
Trial Completion Date		2009-12-15 (estimated)
Registered in ClinicalTrials.gov		NCT00544076
Date Submitted to PDQ		2007-09-14
Information Last Verified		2009-06-21
NCI Grant/Contract Number		CA33572

Back to Top