Clinical trial · Interventional
Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer
Prospective Phase II Randomized Trial of Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder 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)
Bladder cancer is the 4th most common cancer amongst men. If bladder cancer invades the muscle of the bladder or fails local treatments, surgical removal of the bladder (cystectomy) with creation of a new bladder from intestine is required. However, standard cystectomy affects urinary function and sexual function. The investigators are evaluating two modifications to cystectomy to determine to what extent they preserve urinary and sexual function.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Transitional Cell Carcinoma of the Bladder | Bladder Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nerve sparing cystectomy | Procedure | — | UNRESOLVED |
| Prostate capsule sparing cystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Prostate capsule sparing cystectomy Group
- description
- Prostate capsule sparing cystectomy involves removing the entire bladder.
- interventionNames
- Procedure: Prostate capsule sparing cystectomy
- type
- ACTIVE_COMPARATOR
- label
- Nerve sparing cystectomy Group
- description
- Nerve sparing cystectomy involves removal of the whole bladder and the entire prostate.
- interventionNames
- Procedure: Nerve sparing cystectomy
Primary outcomes (1)
- measure
- Post-operative urinary function
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Study subjects will be men 18 years or older * histologic diagnosis of Ta - T2 transitional cell carcinoma within 3 months of enrollment. * no nodal or metastatic disease on pre-operative CT or MRI within 3 months of enrollment. * no evidence of malignancy in the prostate based on 12-core transrectal ultrasound guided prostate needle biopsy and transurethral resection of prostatic urethra16 * candidate for and willingness to undergo a radical cystectomy and orthotopic neobladder by the urologic surgeon performing the procedure. * competent to provide informed consent * able to read and write English * willing to be randomized to PCSC versus NSC. Exclusion Criteria: * histologically proven stage T3 or greater bladder cancer and/or evidence of metastatic disease by work-up described above. * creatinine \> 2.2 mg/dl. * refuse to complete study requirements. * prior pelvic radiation to bladder or prostate. * history of radical prostatectomy.
References
Publications (0)
Data not yet available