NCT05155501 · Weill Medical College of Cornell University
Clinical Trial of Approaches to Prostate Cancer Surgery
(PARTIAL)
What this study is about
This is a forward-looking, randomly assigned controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy.
View original scientific 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.
Interventions
PROCEDURE
Robot-assisted radical prostatectomy (RP)
The conventional approach to prostate cancer surgery
PROCEDURE
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.
Primary outcome measures
Surgical Margin Status as assessed by surgical pathology results
Time frame: 1 week post-surgery
Presence of cancer cells at the prostate margin is standardized as a positive surgical margin through professional guideline consensus.
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
Time frame: 6 months post-surgery
Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL. In accordance with National Comprehensive Cancer Network (NCCN) guidelines, investigators will capture PSA persistence as failure of PSA to fall to undetectable levels, and PSA recurrence as an undetectable PSA after surgery with a subsequent detectable PSA that increases on 2 or more determinations.
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
Time frame: 12 months post-surgery
Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
Time frame: 24 months post-surgery
Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Prior major pelvic surgery or radiotherapy
- Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)
Where
- Duarte, California
- Washington D.C., District of Columbia
- Chicago, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- Hackensack, New Jersey
- Flushing, New York
- New York, New York
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations