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

Sponsor:	Beckman Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00544076

Purpose

RATIONALE: Sildenafil 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	Intervention
Prostate Cancer Sexual Dysfunction and Infertility	Drug: alprostadil Drug: sildenafil citrate Other: questionnaire administration Procedure: laparoscopic surgery Procedure: quality-of-life assessment

Study Type:	Interventional
Study Design:	Supportive Care, Randomized
Official Title:	Erectile Dysfunction Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Erectile Dysfunction Infertility Prostate Cancer

Drug Information available for: Sildenafil Sildenafil citrate Alprostadil

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	204
Study Start Date:	November 2005
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

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.
To describe whether early postoperative maintenance pharmacotherapy with sildenafil citrate can improve return of erectile function at 1 year postoperatively in these patients.
To describe if early postoperative maintenance pharmacotherapy with sildenafil citrate can decrease the time-to-return of erectile function in these patients.

Secondary

To describe whether early postoperative maintenance pharmacotherapy with alprostadil can improve return of erectile function at 1 year postoperatively in these patients.
To describe if early postoperative maintenance pharmacotherapy with alprostadil can decrease the time-to-return of erectile function in these patients.
To compare sexual function quality of life in patients undergoing early postoperative maintenance pharmacotherapy to those without early postoperative maintenance pharmacotherapy.
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.
To describe the dropout rate for alprostadil maintenance pharmacotherapy secondary to urethral pain in patients using 2% lidocaine lubricant.
To describe if penile length is decreased following BNS-RAP.
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.

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.

Eligibility

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

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

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

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544076

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Laura E. Crocitto, MD

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000570272, CHNMC-04071
Study First Received:	October 13, 2007
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00544076 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

sexual dysfunction and infertility
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:

Alprostadil
Infertility
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Hematologic Agents
Enzyme Inhibitors
Urogenital Neoplasms
Sildenafil
Fibrinolytic Agents

Cardiovascular Agents
Genital Diseases, Male
Pharmacologic Actions
Genital Diseases, Female
Neoplasms
Fibrin Modulating Agents
Phosphodiesterase Inhibitors
Neoplasms by Site
Therapeutic Uses
Platelet Aggregation Inhibitors
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009