Clinical trial · Interventional
ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
Erectile Dysfunction Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer
NCT00544076CI-TRIAL-00036317terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual too slow
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Male Erectile Disorder | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Stage II Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alprostadil | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| robotic-assisted laparoscopic surgery | Procedure | — | UNRESOLVED |
| sildenafil citrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Sildenafil Citrate/Mo+Aprostadil/day
- 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.
- interventionNames
- Drug: sildenafil citrate
- Drug: alprostadil
- Procedure: robotic-assisted laparoscopic surgery
- Procedure: quality-of-life assessment
- Other: questionnaire administration
- type
- ACTIVE_COMPARATOR
- label
- Sildenafil Citrate Monthly
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.