NCT05155501

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
25mo left

Started May 2023

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
May 2023Jul 2028

First Submitted

Initial submission to the registry

November 30, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

November 30, 2021

Last Update Submit

April 20, 2026

Conditions

Prostate Cancer

Keywords

radical prostatectomynerve sparingRetzius sparing

Outcome Measures

Primary Outcomes (4)

  • Surgical Margin Status as assessed by surgical pathology results

    Presence of cancer cells at the prostate margin is standardized as a positive surgical margin through professional guideline consensus.

    1 week post-surgery

  • Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

    Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL. In accordance with National Comprehensive Cancer Network (NCCN) guidelines, investigators will capture PSA persistence as failure of PSA to fall to undetectable levels, and PSA recurrence as an undetectable PSA after surgery with a subsequent detectable PSA that increases on 2 or more determinations.

    6 months post-surgery

  • Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

    Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

    12 months post-surgery

  • Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

    Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

    24 months post-surgery

Secondary Outcomes (6)

  • Surgery-Related Adverse Events as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    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)

    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

    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

    Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

  • Patient-reported Decision Regret, as measured by a 5-item questionnaire

    12 months post-surgery

  • +1 more secondary outcomes

Study Arms (2)

Robot-assisted radical prostatectomy (RP)

ACTIVE COMPARATOR

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

Procedure: Robot-assisted radical prostatectomy (RP)

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

EXPERIMENTAL

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.

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

Interventions

Robot-assisted radical prostatectomy (RP)PROCEDURE

The conventional approach to prostate cancer surgery

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

A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.

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

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior major pelvic surgery or radiotherapy
  • Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Beckman Research Institute of City of Hope

Duarte, California, 91010, United States

RECRUITING

Georgetown University

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

RECRUITING

Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

RECRUITING

NewYork-Presbyterian Queens

Flushing, New York, 11355, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (1)

  • 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 2023 Apr 2.

    PMID: 37015291DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jim C Hu, MD, MPH

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

May Ting, MBS

CONTACT

732-757-2448mat7051@med.cornell.edu

Xiaohong Jing, PhD

CONTACT

212-746-4739xij2004@med.cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors (i.e., pathologists) will be blinded to randomization.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 13, 2021

Study Start

May 15, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(9)