RECRUITING

Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer

Quick Facts

Study Start:2023-10-25
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05792722

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects with pathologically confirmed bladder cancer scheduled for radical cystectomy
  2. * Variant histologies of bladder cancer permitted
  3. * Neoadjuvant therapy permitted
  4. * Age \> 18 years old
  5. * Ability to understand and willingness to sign a written informed consent document
  1. * Patients that are not candidates for cystectomy
  2. * Moderate to severe erectile dysfunction with SHIM score \<17
  3. * Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra
  4. * Prior pelvic radiation
  5. * Confirmed prostate cancer:
  6. * 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
  7. * Increased genetic risk of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines:
  8. * ≥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
  9. * ≥1 first-degree relative (father or brother) with: prostate cancer at age ≤60 y
  10. * ≥2 first-, second-, or third-degree relatives with: breast cancer at any age, prostate cancer at any age
  11. * ≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed
  12. * Patients with Lynch syndrome

Contacts and Locations

Study Contact

Armine Smith, MD
CONTACT
202-660-5561
asmit165@jhmi.edu
Riziki' Covington
CONTACT
202-660-6133
rcoving5@jh.edu

Principal Investigator

Armine Smith, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Sibley Memorial Hospital
Washington, District of Columbia, 20016
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Armine Smith, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-25
Study Completion Date2026-07

Study Record Updates

Study Start Date2023-10-25
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Radical Cystectomy
  • Prostate Capsule-Sparing Cystectomy
  • Nerve-Sparing Cystectomy
  • Male

Additional Relevant MeSH Terms

  • Bladder Cancer