Clinical Trial of Approaches to Prostate Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robot-assisted radical prostatectomy (RP), Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP).
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 40 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical TrIAL of Approaches to Prostate cAncer suRgery
Overview
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.
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]
- Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) [Time frame: 6 months post-surgery]
- Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) [Time frame: 12 months post-surgery]
- Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) [Time frame: 24 months post-surgery]
Secondary outcome measures (6)
- Surgery-Related Adverse Events as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Time frame: Up to 30 days following surgery]
- Change in Urinary and Sexual Function, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) [Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery]
- Change in Patient-Reported Penile Shortening and Sexual Function, as measured by a 5-item questionnaire [Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery]
- Change in patient-Reported Penile Curvature/Deformity (Peyronie's Disease), as measured by a 3-item questionnaire [Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery]
- Patient-reported Decision Regret, as measured by a 5-item questionnaire [Time frame: 12 months post-surgery]
- Patient-reported Decision Regret, as measured by a 5-item questionnaire [Time frame: 24 months post-surgery]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Beckman Research Institute of City of Hope — Duarte
- Georgetown University — Washington D.C.
- Northwestern University — Chicago
- Johns Hopkins University — Baltimore
- Beth Israel Deaconess Medical Center (BIDMC) — Boston
- Hackensack Meridian Health — Hackensack
- NewYork-Presbyterian Queens — Flushing
- Memorial Sloan Kettering Cancer Center — New York
- … and 1 more center
Publications
- Stangl-Kremser J, Kowalczyk K, Schaeffer EM, Allaf M, Scherr D, Yang X, Matoso A, Azumi N, Robinson B, Vickers A, Hu JC. Study protocol for a prospective, multi-centered randomized controlled trial comparing pelvic fascia-sparing radical prostatectomy with conventional robotic-assisted prostatectomy: The PARTIAL trial. Contemp Clin Trials. 2023 May;128:107168. doi: 10.1016/j.cct.2023.107168. Epub PMID 37015291
Identifiers
NCT: NCT05155501 · 21-07023781 · 1R01CA259173