Clinical trial NCT05155501: Clinical Trial of Approaches to Prostate Cancer Surgery
Official title: Clinical TrIAL of Approaches to Prostate cAncer suRgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: radical prostatectomy
nerve sparing
Retzius sparing
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2021-12-13
Enrollment: 600
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Surgical Margin Status as assessed by surgical pathology results
timeFrame: 1 week post-surgery
measure: Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
timeFrame: 6 months post-surgery
measure: Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
timeFrame: 12 months post-surgery
measure: Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
timeFrame: 24 months post-surgery
Secondary outcomes:
measure: Surgery-Related Adverse Events as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Up to 30 days following surgery
measure: Change in Urinary and Sexual Function, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
timeFrame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
measure: Change in Patient-Reported Penile Shortening and Sexual Function, as measured by a 5-item questionnaire
timeFrame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
measure: Change in patient-Reported Penile Curvature/Deformity (Peyronie's Disease), as measured by a 3-item questionnaire
timeFrame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
measure: Patient-reported Decision Regret, as measured by a 5-item questionnaire
timeFrame: 12 months post-surgery
measure: Patient-reported Decision Regret, as measured by a 5-item questionnaire
timeFrame: 24 months post-surgery
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Flushing
country: United States
facility: NewYork-Presbyterian Queens
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jim C Hu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: