Clinical Trial of Approaches to Prostate Cancer Surgery (PARTIAL)

April 20, 2026 updated by: Weill Medical College of Cornell University

Clinical TrIAL of Approaches to Prostate cAncer suRgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • Beckman Research Institute of City of Hope
        • Contact:
        • Principal Investigator:
          • Clayton Lau, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University
        • Contact:
        • Principal Investigator:
          • Keith Kowalczyk, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Edward M Schaeffer, MD PhD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Mohamad E Allaf, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack Meridian Health
        • Principal Investigator:
          • Nitin Yerram, MD
        • Contact:
    • New York
      • Flushing, New York, United States, 11355
        • Recruiting
        • NewYork-Presbyterian Queens
        • Contact:
        • Principal Investigator:
          • Neal Patel, MD
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Behfar Ehdaie, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Robot-assisted radical prostatectomy (RP)
The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.
Procedure: Robot-assisted radical prostatectomy (RP)
The conventional approach to prostate cancer surgery
Experimental: 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. These structures are disrupted and removed during conventional radical prostatectomy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Margin Status as assessed by surgical pathology results
Time Frame: 1 week post-surgery
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)
Time Frame: 6 months post-surgery

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)
Time Frame: 12 months post-surgery
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)
Time Frame: 24 months post-surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

The questionnaire will include 20 items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), survey items pertinent to short-stay cancer surgery.

The questionnaire will assess patient-reported complications and adverse events, such as constipation, nausea and vomiting, fever, chills, fatigue, pain, shortness of breath, swelling and bruising, redness and discharge at the surgical incision site, anxiety, and flatulence (ileus). It will also assess patient contacts with physicians and admittance to urgent care or the emergency room.
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

The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) is a 7-item questionnaire assessing two health-related quality of life domains: urinary and sexual function. All questions refer to patients' health and symptoms in the last four weeks.

Each domain is scored out of 12 points, with higher scores indicating more complications.

In total, the EPIC-CP score is the final sum of the two domains, with higher scores indicating more issues related to overall prostate cancer quality of life.
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

This is a 5-item questionnaire, published in the New England Journal of Medicine (NEJM), that has face validity for assessing penile shortening, self-esteem, and erectile function after radical prostatectomy.

Question 1 assesses patients' perceived penile length post-surgery, compared to penile length at 30 years of age. It consists of two possible responses: Yes or No.

Questions 2 and 3 assesses patients' ability to obtain and quality of spontaneous morning erections and sexual activity-related erections. It consists of five possible responses: ranging from "No erections" to "Erections always sufficient".

Question 4 is a visual digital scale assessing patients' present quality of life. It is scored on a scale of 1-7, with higher scores indicating high quality of life.

Question 5 is a visual digital scale assessing patients' present self-esteem. It is scored on a scale of 1-7, with higher scores indicating high self-esteem.
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

This is a validated, 3-item questionnaire assessing presence of Peyronie's disease. The penile deformity items were validated by blinded clinical examination with 100% sensitivity and 99.4% specificity.

Question 1 assesses penile hardening/plaques in the flaccid state. Question 2 assesses penile curvature in the erect state. Question 3 assesses pain associated with erection. Each question consists of two possible responses: Yes or No.
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

This is a 5-item questionnaire assessing treatment regret that was developed and validated in men with prostate cancer.

Each item is scored on a 5 point scale ranging from "Strongly Agree" to "Strongly Disagree". Responses are converted to a score ranging from 0-100, with higher scores indicating more regret.
12 months post-surgery
Patient-reported Decision Regret, as measured by a 5-item questionnaire
Time Frame: 24 months post-surgery
This is a 5-item questionnaire assessing treatment regret that was developed and validated in men with prostate cancer.
24 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Jim C Hu, MD, MPH, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-07023781
  • 1R01CA259173 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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