Comparing two surgical approaches for prostate cancer treatment
Clinical TrIAL of Approaches to Prostate cAncer suRgery
This study is testing whether a new type of prostate surgery that spares more tissue can help men with localized prostate cancer have better cancer control and quality of life compared to the standard surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | Male |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 9 sites (Duarte, California and 8 other locations) |
| Trial ID | NCT05155501 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, randomized controlled trial designed to compare the outcomes of pelvic fascia-sparing radical prostatectomy with standard radical prostatectomy in men diagnosed with clinically localized prostate cancer. The study aims to evaluate cancer control and health-related quality of life, focusing on urinary function, sexual function, and risks of complications such as penile shortening and inguinal hernia. Participants will be randomly assigned to one of the two surgical approaches, and outcomes will be assessed through patient questionnaires and medical record reviews.
Who should consider this trial
Good fit: Ideal candidates for this study are adult men aged 40 to 80 who are scheduled for radical prostatectomy due to clinically localized prostate cancer.
Not a fit: Patients with prior major pelvic surgery or radiotherapy, or those suspected of having lymph node involvement, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing prostate cancer surgery.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male sex * 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 this trial is running
Duarte, California and 8 other locations
- Beckman Research Institute of City of Hope — Duarte, California, United States (Recruiting)
- Georgetown University — Washington D.C., District of Columbia, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts, United States (Recruiting)
- Hackensack Meridian Health — Hackensack, New Jersey, United States (Recruiting)
- NewYork-Presbyterian Queens — Flushing, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jim C Hu, MD, MPH — Weill Medical College of Cornell University
- Study coordinator: May Ting, MBS
- Email: mat7051@med.cornell.edu
- Phone: 732-757-2448
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.