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

City of Hope

Status and phase: Terminated; Phase 3

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

Treatments: Drug: alprostadil; Other: questionnaire administration; Drug: sildenafil citrate; Procedure: robotic-assisted laparoscopic surgery; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT00544076

CDR0000570272 (Registry Identifier)

NCI-2009-01602 (Registry Identifier)

04071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 3 patient groups

Sildenafil Citrate/Mo+Aprostadil/day

Experimental group

Description:

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.

Treatment:

Procedure: quality-of-life assessment

Procedure: robotic-assisted laparoscopic surgery

Drug: sildenafil citrate

Drug: alprostadil

Other: questionnaire administration

Sildenafil Citrate Monthly

Active Comparator group

Description:

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.

Treatment:

Procedure: quality-of-life assessment

Procedure: robotic-assisted laparoscopic surgery

Drug: sildenafil citrate

Other: questionnaire administration

Daily Sildenafil Citrate

Experimental group

Description:

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.

Treatment:

Procedure: quality-of-life assessment

Procedure: robotic-assisted laparoscopic surgery

Drug: sildenafil citrate

Other: questionnaire administration