Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

City of Hope Comprehensive Cancer Center

Laura Crocitto

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00544076
Information obtained from ClinicalTrials.gov on December 14, 2011

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