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

NCT ID: NCT00544076

Last Updated: 2019-01-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2012-04-30

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.

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.

Conditions

Prostate Cancer; Male Erectile Disorder; Stage I Prostate Cancer; Stage II Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

sildenafil citrate

Intervention Type: DRUG

Given orally

alprostadil

Intervention Type: DRUG

Given intraurethrally

robotic-assisted laparoscopic surgery

Intervention Type: PROCEDURE

Undergo prostatectomy

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

questionnaire administration

Intervention Type: OTHER

Ancillary studies

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.

Group Type: ACTIVE_COMPARATOR

sildenafil citrate

Intervention Type: DRUG

Given orally

robotic-assisted laparoscopic surgery

Intervention Type: PROCEDURE

Undergo prostatectomy

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

questionnaire administration

Intervention Type: OTHER

Ancillary studies

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.

Group Type: EXPERIMENTAL

sildenafil citrate

Intervention Type: DRUG

Given orally

robotic-assisted laparoscopic surgery

Intervention Type: PROCEDURE

Undergo prostatectomy

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

questionnaire administration

Intervention Type: OTHER

Ancillary studies

Interventions

sildenafil citrate

Given orally

Intervention Type: DRUG

alprostadil

Given intraurethrally

Intervention Type: DRUG

robotic-assisted laparoscopic surgery

Undergo prostatectomy

Intervention Type: PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Viagra; Caverject; MUSE; PGE1; prostaglandin E1; quality of life assessment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Crocitto

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2009-01602

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000570272

Identifier Type: REGISTRY

Identifier Source: secondary_id

04071

Identifier Type: -

Identifier Source: org_study_id