NCT05792722Recruiting
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy. Patients will be randomized to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy. Patients will be monitored following standard of care guidelines and clinical data will be collected. Patients in both groups will be asked to complete an erectile function questionnaire at multiple timepoints. Patients who receive an orthotopic neobladder will be asked to complete a questionnaire to monitor urinary function at multiple timepoints. Patient adverse events will be monitored to ensure patients safety.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 16 Mar 2023
- Start date
- 25 Oct 2023
- Primary completion date
- Jul 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- Prostate cancer, Bladder cancer
- NCT number
- NCT05792722
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 25 Oct 2023 to the primary completion date, Jul 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiation
Other illness
- Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra
- Confirmed prostate cancer:
- Patients with abnormal Digital rectal exam (DRE), PSA \>3 or Prostate Imaging Reporting \& Data System (PIRADS) 4 lesions on prostate Multiparametric MRI (mpMRI) will undergo prostate biopsy to rule out prostate cancer
- Increased genetic risk of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines:
- ≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed
- Patients with Lynch syndrome
Age
- ≥1 first-, second-, or third-degree relative with: breast cancer at age ≤50 y, colorectal or endometrial cancer at age ≤50 y, male breast cancer at any age, ovarian cancer at any age, exocrine pancreatic cancer at any age, metastatic, regional, very-high-risk, high-risk prostate cancer at any age
- ≥1 first-degree relative (father or brother) with: prostate cancer at age ≤60 y
- ≥2 first-, second-, or third-degree relatives with: breast cancer at any age, prostate cancer at any age
Other
- Patients that are not candidates for cystectomy
- Moderate to severe erectile dysfunction with SHIM score \<17
Who the study is looking for
- Subjects with pathologically confirmed bladder cancer scheduled for radical cystectomy
- Variant histologies of bladder cancer permitted
- Neoadjuvant therapy permitted
- Age \> 18 years old
- Ability to understand and willingness to sign a written informed consent document
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Sibley Memorial Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.