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

Sponsor:	City of Hope Medical Center
Information provided by (Responsible Party):	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00544076

Purpose

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	Intervention
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Erectile Dysfunction Prostate Cancer

Drug Information available for: Citric acid Sildenafil Sildenafil citrate Alprostadil Sodium Citrate

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:

Potency rates (ability to obtain an erection sufficient for penetration) without assistance in those patients receiving maintenance Viagra compared to non-pharmacology controls [ Time Frame: At 12 months following BNS-RAP ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Potency rates without assistance in those patients receiving maintenance MUSE compared to non-pharmacology controls [ Time Frame: At 12 months following BNS-RAP ] [ Designated as safety issue: No ]
Potency rates with or without assistance in the control group versus maintenance MUSE or maintenance Viagra [ Time Frame: At 1, 3, 6, 9, and 18 months ] [ Designated as safety issue: No ]
SHIMS-5 scores in the control groups versus maintenance MUSE or maintenance Viagra groups [ Time Frame: At 1, 3, 6, 9, 12, and 18 months ] [ Designated as safety issue: No ]
Penile length [ Time Frame: At pre-treatment and 18 months ] [ Designated as safety issue: No ]
Dropout rates in the MUSE maintenance therapy group secondary to penile burning/pain post MUSE usage [ Time Frame: 18 months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	204
Study Start Date:	January 2006
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: sildenafil citrate Given orally Other Name: 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 Name: quality of life assessment Other: questionnaire administration Ancillary studies
Active Comparator: Arm II Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months.	Drug: sildenafil citrate Given orally Other Name: Viagra Procedure: robotic-assisted laparoscopic surgery Undergo prostatectomy Procedure: quality-of-life assessment Ancillary studies Other Name: quality of life assessment Other: questionnaire administration Ancillary studies
Experimental: 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.	Drug: sildenafil citrate Given orally Other Name: Viagra Procedure: robotic-assisted laparoscopic surgery Undergo prostatectomy Procedure: quality-of-life assessment Ancillary studies Other Name: quality of life assessment Other: questionnaire administration Ancillary studies

Detailed 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.

Eligibility

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

Criteria

Inclusion

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

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

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

Locations

United States, California
City of Hope
Duarte, California, United States, 91010

Sponsors and Collaborators

City of Hope Medical Center

Investigators

Principal Investigator:

Laura Crocitto

Beckman Research Institute

More Information

No publications provided

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00544076 History of Changes
Other Study ID Numbers:	04071, NCI-2009-01602, CDR0000570272
Study First Received:	October 13, 2007
Last Updated:	September 20, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Alprostadil
Sildenafil
Citric Acid

Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Chelating Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012