Pfizer COVID-19 vaccine appointments are available to our patients. Sign up for Connect today to schedule your vaccination.

Pelvic fascia spARing radical prostatectomy TrIAL (PARTIAL)

Clinical Trial Details

Doctors know a lot about performing prostate surgeries. However, we are always trying to learn more and improve our skills for our patients' benefit. We want to try and make prostate surgeries safer, with fewer side effects for the patient, and look for a better way to remove cancer. In this study, we will monitor if there are problems after a participant's surgery. We will also document the results of the surgery and patient-reported quality of life.

We are asking individuals who join the study if they would be interested in hearing about a different, although comparable, type of prostate surgery. Those who agree to participate may hear about this approach and decide whether they are interested. None of the changes we are considering have significant risks or involve large changes to the prostate surgery.

Traditional radical prostatectomy is the most popular treatment for clinically significant prostate cancer, however significant risks including urinary incontinence, erectile dysfunction, penile shortening, penile curvature/ deformation (Peyronie's disease), and inguinal hernia, are common.

Pelvic fascia-sparing radical prostatectomy is a new surgical technique that may preserve fascial support structures, arterial supply to the penis, and nerves that are severed and resected during conventional radical prostatectomy.

This study will enroll adult men undergoing radical prostatectomy for clinically localized prostate cancer. Participants will be randomized to receive either radical prostatectomy or pelvic fascia-sparing radical prostatectomy (PFS-RP).

Participation entails of 5 brief surveys (baseline, 1 month, 6 months, 12 months, 24 months) assessing their urinary, sexual, and lifestyle functions as they relate to recovery. The final survey is at 24 months which ends participation in the study.

Key Eligibility: 

 Inclusion Criteria
   1. Age ≥40 years and ≤85 years
   2. Scheduled for radical prostatectomy for clinically localized prostate cancer
   
   Exclusion Criteria
   1. Prior major pelvic surgery or radiotherapy
   2. Prior focal therapy or radiotherapy for prostate cancer

Detailed eligibility will be discussed when reaching out to the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Bouchra Benghomari
857-287-6801
bob4004@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2107023781

ClinicalTrials.gov:

NCT05155501

Sponsor:

21-02-348-380

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease