ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
Stopped early · Phase 3
Conditions studied: Prostate Cancer, Male Erectile Disorder, Stage I Prostate Cancer, Stage II Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00544076
- Run by
- City of Hope Medical Center
- People needed
- 110
- Starts
- 2006-01-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2019-01-02
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- City of Hope — Duarte, California, United States
Full record on ClinicalTrials.gov
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