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Clinical Trial of Approaches to Prostate Cancer Surgery (PARTIAL)

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Robot-assisted radical prostatectomy (RP)

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

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring radical prostatectomy, nerve sparing, Retzius sparing

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

Georgetown University
Northwestern University
Johns Hopkins University
Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Robot-assisted radical prostatectomy (RP)

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

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

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

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.

Change in Urinary and Sexual Function, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)

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.

Change in Patient-Reported Penile Shortening and Sexual Function, as measured by a 5-item questionnaire

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.

Change in patient-Reported Penile Curvature/Deformity (Peyronie's Disease), as measured by a 3-item questionnaire

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.

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

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.

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

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

Full Information

NCT ID

NCT05155501

First Posted

November 30, 2021

Last Updated

May 22, 2023

Sponsor

Weill Medical College of Cornell University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05155501

Brief Title

Clinical Trial of Approaches to Prostate Cancer Surgery

Acronym

PARTIAL

Official Title

Clinical TrIAL of Approaches to Prostate cAncer suRgery

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 15, 2023 (Actual)

Primary Completion Date

May 2026 (Anticipated)

Study Completion Date

August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

radical prostatectomy, nerve sparing, Retzius sparing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Outcomes assessors (i.e., pathologists) will be blinded to randomization.

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Robot-assisted radical prostatectomy (RP)

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Robot-assisted radical prostatectomy (RP)

Intervention Description

The conventional approach to prostate cancer surgery

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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 Measure Information:

Title

Surgical Margin Status as assessed by surgical pathology results

Description

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

Time Frame

1 week post-surgery

Title

Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

Description

Time Frame

6 months post-surgery

Title

Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

Description

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

Time Frame

12 months post-surgery

Title

Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

Description

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

Time Frame

24 months post-surgery

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Up to 30 days following surgery

Title

Change in Urinary and Sexual Function, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)

Description

Time Frame

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

Title

Change in Patient-Reported Penile Shortening and Sexual Function, as measured by a 5-item questionnaire

Description

Time Frame

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

Title

Change in patient-Reported Penile Curvature/Deformity (Peyronie's Disease), as measured by a 3-item questionnaire

Description

Time Frame

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

Title

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

Description

Time Frame

12 months post-surgery

Title

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

Description

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

Time Frame

24 months post-surgery

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jim C Hu, MD MPH

Phone

646-962-9600

jch9011@med.cornell.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Flynn

Phone

212.746.4739

thf3001@med.cornell.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jim C Hu, MD MPH

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georgetown University

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Keith Kowalczyk, MD

Keith.Kowalczyk@medstar.net

First Name & Middle Initial & Last Name & Degree

Keith Kowalczyk, MD

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mary Kate Keeter, MPH

Phone

312-694-6082

mary.fitzgerald@northwestern.edu

First Name & Middle Initial & Last Name & Degree

Edward M Schaeffer, MD PhD

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rana Harb, MS

Phone

410-502-5500

rharb1@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Mohamad E Allaf, MD

Facility Name

Weill Cornell Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jim C Hu, MD MPH

Phone

646-962-9600

jch9011@med.cornell.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Trial of Approaches to Prostate Cancer Surgery

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