Evaluating prostate-sparing surgery for bladder cancer
A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer
This study is testing a new type of surgery for bladder cancer that aims to preserve the prostate and improve recovery for men without affecting cancer control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT05792722 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess whether prostate-capsule-sparing radical cystectomy can enhance functional outcomes without compromising oncologic results in male patients with bladder cancer. Participants will be randomly assigned to either a prostate capsule-sparing or a nerve-sparing radical cystectomy. The study will monitor patients post-operatively for up to 24 months, collecting data on erectile and urinary function through standardized questionnaires. Adverse events will also be tracked to ensure patient safety throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include male patients over 18 years old with pathologically confirmed bladder cancer scheduled for radical cystectomy.
Not a fit: Patients with moderate to severe erectile dysfunction, bladder cancer involving the bladder neck or prostate, or confirmed prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved quality of life for patients by preserving erectile and urinary function after surgery.
How similar studies have performed: Other studies have shown promise with nerve-sparing techniques, but the prostate-capsule-sparing approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients that are not candidates for cystectomy * Moderate to severe erectile dysfunction with SHIM score \<17 * Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra * Prior pelvic radiation * 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: * ≥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 * ≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed * Patients with Lynch syndrome
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Armine Smith, MD — Johns Hopkins University
- Study coordinator: Armine Smith, MD
- Email: asmit165@jhmi.edu
- Phone: 202-660-5561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.