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Procedure

Surgical Approaches for Prostate Cancer (PARTIAL Trial)

N/A

Recruiting

Led By Jim C Hu, MD MPH

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for radical prostatectomy for clinically localized prostate cancer

Male sex

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

Awards & highlights

PARTIAL Trial Summary

This trial will compare two types of prostate cancer surgery to see which is better at controlling cancer and improving quality of life.

Who is the study for?

This trial is for men aged 40-80 who are scheduled for prostate cancer surgery, can understand English or Spanish, and agree to follow the study rules. It's not for those with advanced lymph node involvement or a history of major pelvic surgery/radiotherapy.Check my eligibility

What is being tested?

The study compares two types of prostate cancer surgeries: standard robot-assisted radical prostatectomy (RP) and a nerve-sparing version called PFS-RP. The goal is to see if PFS-RP offers better urinary function and sexual health without compromising cancer control.See study design

What are the potential side effects?

Potential side effects from both surgeries may include changes in urinary function, sexual health issues like erectile dysfunction, penile shortening/deformity, and possibly an increased risk of developing inguinal hernia.

PARTIAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to remove my prostate due to cancer.

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I am male.

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I am between 40 and 80 years old.

PARTIAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 6 months, 12 months, and 24 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

Surgical Margin Status as assessed by surgical pathology results

Secondary outcome measures

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

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

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

+2 more

PARTIAL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)Experimental Treatment1 Intervention

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.

Group II: Robot-assisted radical prostatectomy (RP)Active Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,315,709 Total Patients Enrolled

48 Trials studying Prostate Cancer

35,039 Patients Enrolled for Prostate Cancer

National Institutes of Health (NIH)NIH

2,698 Previous Clinical Trials

7,491,899 Total Patients Enrolled

28 Trials studying Prostate Cancer

6,357 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,473 Total Patients Enrolled

560 Trials studying Prostate Cancer

506,495 Patients Enrolled for Prostate Cancer

Media Library

Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05155501 — N/A

Prostate Cancer Research Study Groups: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP), Robot-assisted radical prostatectomy (RP)

Prostate Cancer Clinical Trial 2023: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) Highlights & Side Effects. Trial Name: NCT05155501 — N/A

Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05155501 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment have any open recruitment slots?

"As indicated on clinicaltrials.gov, this trial has closed its recruitment window; it was initially posted on December 1st 2022 and last modified on November 18th of the same year. Nevertheless, there are 1321 other medical trials that remain open for patient enrollment at present."

Answered by AI

Where can this research be conducted?

"Four locations are currently running the trial, including Georgetown University in Washington D.C., Northwestern University in Chicago and Weill Cornell Medicine situated in New york City - with one additional site."

Answered by AI

Is it possible to partake in this medical experiment?

"To join this clinical trial, 600 participants with localized prostate cancer who are aged between 40 and 80 must meet the following criteria: male sex, literacy in English or Spanish, willingness to sign consent forms and comply with guidelines set out by the protocol."

Answered by AI

What endpoints are being sought through this clinical investigation?

"The primary goal of this medical trial, which will be monitored for a period spanning one week post-surgery, is to measure Biochemical Recurrence through Prostate Specific Antigen (PSA). Secondary objectives involve evaluating Change in Urinary and Sexual Function using the Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP), assessing Shift in Patient-Reported Penile Shortening and Sexual Function with a 5 question survey published by New England Journal of Medicine (NEJM) as well as obtaining insights on Patient-reported Decision Regret with another 5 item questionnaire that was developed especially for men suffering from prostate cancer."

Answered by AI