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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00544076
Recruitment Status : Terminated (Accrual too slow)
First Posted : October 16, 2007
Results First Posted : January 2, 2019
Last Update Posted : January 2, 2019
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center

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.


Condition or disease Intervention/treatment Phase
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 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : January 2006
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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: 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.
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: 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.
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




Primary Outcome Measures :
  1. Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months [ Time Frame: 12 months following BNS-RAP ]
    Potency rates (ability to obtain an erection sufficient for penetration) without assistance in those patients receiving maintenance Viagra compared to non-pharmacology controls was compared at 12 months from start of treatment using the fisher's exact test


Secondary Outcome Measures :
  1. Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra [ Time Frame: At 6 and 18 months ]
    Potency rates with or without assistance in the control group versus maintenance MUSE or maintenance Viagra were compared at each of 6 and 18 months

  2. 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 ]
    Median and range of SHIM scores evaluated at 1, 3, 6, 9, 12, and 18 months. SHIMS-5 is the Sexual Health Inventory for Men, which includes 5 questions that are scored from 1 to 5 each. The total score is obtained by adding all five response scores, and can range from 5 to 25 when all 5 questions are answered. Questions that are left unanswered are scored as a 0, and can result in an overall score lower than 5 (as low as 0). Higher scores are more desirable. A Score of 22-25 = no ED, 17-21=Mild ED, 12-16=Mild to moderate ED, 8-11=Moderate ED, and 5-7 =Severe ED (ED=Erectile Dysfunction). There are no sub-scale scores within this questionnaire.

  3. Penile Length [ Time Frame: At pre-treatment and 18 months ]
    measurement of penile length in centimeters



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544076


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
Investigators
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Principal Investigator: Laura Crocitto City of Hope Medical Center
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00544076    
Other Study ID Numbers: 04071
NCI-2009-01602 ( Registry Identifier: NCI CTRP )
CDR0000570272 ( Registry Identifier: PDQ )
First Posted: October 16, 2007    Key Record Dates
Results First Posted: January 2, 2019
Last Update Posted: January 2, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Alprostadil
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents
Platelet Aggregation Inhibitors