Clinical Trial of Approaches to Prostate Cancer Surgery
NCT ID: NCT05155501
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
600 participants
INTERVENTIONAL
2023-05-15
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Open and Robotic Prostatectomy
NCT01325506
Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer
NCT04981834
Modifications to Radical Prostatectomy: Feasibility Study
NCT00928850
Robotic Athermal Nerve-Sparing Radical Prostatectomy
NCT02079155
Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
NCT00027794
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will enroll adult men undergoing radical prostatectomy for clinically localized prostate cancer. Subjects will be randomized to receive either radical prostatectomy or pelvic fascia-sparing radical prostatectomy. Investigators will compare cancer control and health-related quality of life outcomes through patient questionnaires and medical record review.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Robot-assisted radical prostatectomy (RP)
The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.
Robot-assisted radical prostatectomy (RP)
The conventional approach to prostate cancer surgery
Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate. These structures are disrupted and removed during conventional radical prostatectomy.
Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Robot-assisted radical prostatectomy (RP)
The conventional approach to prostate cancer surgery
Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥40 years or ≤80 years
* Scheduled for radical prostatectomy for clinically localized prostate cancer
* Able to read and speak English or Spanish
* Willingness to sign informed consent and adhere to the study protocol
Exclusion Criteria
* Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)
40 Years
80 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Weill Medical College of Cornell University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jim C Hu, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Georgetown University
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
NewYork-Presbyterian Queens
Flushing, New York, United States
Weill Cornell Medicine
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Stangl-Kremser J, Kowalczyk K, Schaeffer EM, Allaf M, Scherr D, Yang X, Matoso A, Azumi N, Robinson B, Vickers A, Hu JC. Study protocol for a prospective, multi-centered randomized controlled trial comparing pelvic fascia-sparing radical prostatectomy with conventional robotic-assisted prostatectomy: The PARTIAL trial. Contemp Clin Trials. 2023 May;128:107168. doi: 10.1016/j.cct.2023.107168. Epub 2023 Apr 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-07023781
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.