Clinical trial · Interventional
Clinical Trial of Approaches to Prostate Cancer Surgery
Clinical TrIAL of Approaches to Prostate cAncer suRgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) | Procedure | — | UNRESOLVED |
| Robot-assisted radical prostatectomy (RP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Robot-assisted radical prostatectomy (RP)
- description
- The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.
- interventionNames
- Procedure: Robot-assisted radical prostatectomy (RP)
- type
- EXPERIMENTAL
- label
- Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
- 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.
- interventionNames
- Procedure: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDStangl-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 2023 Apr 2. PMID 37015291