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Tests treatment safety and results for Bladder Cancer
Official title Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
ClinicalTrials.gov ID: NCT05792722
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- people 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
You likely can't join if
- 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...
See the full eligibility criteria
- people 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
- 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...
- ≥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
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.