Clinical trial · Interventional
Prospective Randomized Trial of Seminal Vesicle-Sparing Prostatectomy and Nerve-Sparing Radical Prostatectomy in Men With Clinically Localized Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Surgical removal of the prostate (radical prostatectomy) is a common and generally effective treatment for prostate cancer. However, standard prostatectomy can affect urinary continence and sexual function. Different surgical techniques, such as nerve-sparing prostatectomy and seminal vesicle-sparing prostatectomy, may limit these treatment-related effects. In a standard prostatectomy, the seminal vesicles are removed completely. In contrast, during a seminal vesicle-sparing prostatectomy, the surgeon leaves a portion of the seminal vesicles intact. This is done because the nerves that are important to urinary continence and erectile function are located close to the seminal vesicles. The purpose of this study is to determine whether patients who undergo nerve-sparing prostatectomy with seminal vesicle-sparing experience better urinary and sexual functioning after surgery than patients who undergo standard nerve-sparing prostatectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nerve-sparing radical prostatectomy | Procedure | — | UNRESOLVED |
| seminal vesicle-sparing radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- nerve-sparing radical prostatectomy
- interventionNames
- Procedure: nerve-sparing radical prostatectomy
- type
- ACTIVE_COMPARATOR
- label
- Treatment Group
- description
- seminal vesicle-sparing radical prostatectomy
- interventionNames
- Procedure: seminal vesicle-sparing radical prostatectomy
Primary outcomes (1)
- measure
- Mean sexual function domain score of the two groups as measured by the Expanded Prostate Cancer Index Composite
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men with biopsy-proven histologic diagnosis of prostate adenocarcinoma * Low risk for seminal vesicle invasions defined by: Clinical stage T1c/tumor 2-node 0-metastasis 0, Gleason score ≤ 6, PSA ≤ 10 ng/ml, positive prostate biopsy core proportion ≤ 1/2 (50%) or clinical stage T1c/T2N0M0, Gleason ≤ 7, PSA ≤ 6 ng/ml, positive biopsy core proportion ≤ 1/3 (33.3%) * Sexually potent, defined as International Index of Erectile Function score ≥ 21, prior to randomization and surgery * Competent to provide informed consent * Able to read and write English * Candidate for bilateral nerve-sparing * Willing to be followed for 12 months post-surgery Exclusion Criteria: * Intermediate or high risk for seminal vesicle invasion * Unwilling to be randomized to either treatment arm * Pre-operative treatment with radiation and/or hormone therapy * Planned adjuvant radiation and/or hormonal therapy
References
Publications (0)
Data not yet available