ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
Prostate Cancer, Male Erectile Disorder, Stage I Prostate Cancer
About this trial
This is an interventional supportive care trial for Prostate Cancer
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
Sites / Locations
- City of Hope
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Sildenafil Citrate/Mo+Aprostadil/day
Sildenafil Citrate Monthly
Daily Sildenafil Citrate
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.
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.
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.