NCT05792722 Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
| NCT ID | NCT05792722 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-10-25 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2023-10-25 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Armine Smith, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05792722 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05792722 currently recruiting?
Yes, NCT05792722 is actively recruiting participants. Contact the research team at asmit165@jhmi.edu for enrollment information.
Where is the NCT05792722 trial being conducted?
This trial is being conducted at Washington D.C., United States, Baltimore, United States.
Who is sponsoring the NCT05792722 clinical trial?
NCT05792722 is sponsored by Johns Hopkins University. The principal investigator is Armine Smith, MD at Johns Hopkins University. The trial plans to enroll 70 participants.
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