ED Recovery in Men Age

Status:
Terminated

Trial end date:
2012-04-01

Target enrollment:
0

Participant gender:
Male

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Treatments: Alprostadil; Citric Acid; Sildenafil Citrate

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