RECRUITING

Clinical Trial of Approaches to Prostate Cancer Surgery

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

This is a prospective, randomized controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy. The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have similar cancer control (primary outcome) and sexual function outcomes; and significantly better urinary function, penile shortening/deformity and inguinal hernia risks as compared to radical prostatectomy.

Official Title

Clinical TrIAL of Approaches to Prostate cAncer suRgery

Quick Facts

Study Start:2023-05-15
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05155501

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:40 Years to 80 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male sex
  2. * Age ≥40 years or ≤80 years
  3. * Scheduled for radical prostatectomy for clinically localized prostate cancer
  4. * Able to read and speak English or Spanish
  5. * Willingness to sign informed consent and adhere to the study protocol
  1. * Prior major pelvic surgery or radiotherapy
  2. * Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)

Contacts and Locations

Study Contact

May Ting, MBS
CONTACT
732-757-2448
mat7051@med.cornell.edu
Xiaohong Jing, PhD
CONTACT
212-746-4739
xij2004@med.cornell.edu

Principal Investigator

Jim C Hu, MD, MPH
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Georgetown University
Washington, District of Columbia, 20007
United States
Northwestern University
Chicago, Illinois, 60611
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Weill Cornell Medicine
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Jim C Hu, MD, MPH, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell 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 Date2023-05-15
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-05-15
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • radical prostatectomy
  • nerve sparing
  • Retzius sparing

Additional Relevant MeSH Terms

  • Prostate Cancer