Clinical Trial of Approaches to Prostate Cancer Surgery (PARTIAL)

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Robot-assisted radical prostatectomy (RP); Procedure: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05155501

1R01CA259173 (U.S. NIH Grant/Contract)

21-07023781

Details and patient eligibility

About

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.

Full description

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. 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.

Enrollment: 600 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

600 participants in 2 patient groups

Robot-assisted radical prostatectomy (RP)

Active Comparator group

Description:

The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.

Treatment:

Procedure: Robot-assisted radical prostatectomy (RP)

Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

Experimental group

Description:

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.

Treatment:

Procedure: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)