600 Participants Needed

Surgical Approaches for Prostate Cancer

(PARTIAL Trial)

Recruiting at 4 trial locations
JC
TF
BS
MT
XJ
Overseen ByXiaohong Jing, PhD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Weill Medical College of Cornell University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares a new type of prostate cancer surgery to the standard one. The new surgery aims to avoid cutting important tissues and nerves, which might help reduce side effects like urinary problems and sexual dysfunction. The study will see if this new method controls cancer just as well while improving quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is pelvic fascia-sparing radical prostatectomy safe for humans?

Research suggests that pelvic fascia-sparing radical prostatectomy is generally safe for humans. Studies have shown that it can improve urinary continence recovery and reduce operative time without increasing complications compared to conventional methods.12345

What makes the pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) treatment unique for prostate cancer?

The pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) is unique because it preserves more of the natural structures around the prostate, which may lead to faster recovery of urinary function and fewer complications like penile changes and inguinal hernias compared to conventional robotic-assisted prostatectomy. However, it might have a higher risk of leaving cancerous tissue behind, and more research is needed to confirm these outcomes.13678

What data supports the effectiveness of the treatment Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) for prostate cancer?

Research suggests that preserving the pelvic fascia during robot-assisted radical prostatectomy can lead to faster recovery of urinary function and fewer complications like penile changes and inguinal hernias, without compromising surgical outcomes. However, high-level evidence is still needed to confirm these benefits.12379

Who Is on the Research Team?

JC

Jim C Hu, MD, MPH

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willingness to sign informed consent and adhere to the study protocol
I am scheduled for surgery to remove my prostate due to cancer.
I am male.
See 1 more

Exclusion Criteria

I have had major surgery or radiation treatment in my pelvic area.
Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either pelvic fascia-sparing radical prostatectomy or standard radical prostatectomy

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of urinary and sexual function, penile shortening, and curvature

24 months
Multiple visits at 1 month, 6 months, 12 months, and 24 months post-surgery

Post-surgery Monitoring

Monitoring of biochemical recurrence and surgical margin status

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
  • Robot-assisted radical prostatectomy (RP)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)Experimental Treatment1 Intervention
Group II: Robot-assisted radical prostatectomy (RP)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Patients who underwent Retzius-sparing robotic-assisted radical prostatectomy (RS-RARP) reported significantly less penile shortening (41.7% vs 64.9%) and lower rates of Peyronie's disease (0% vs 8.7%) compared to those who had standard robotic-assisted radical prostatectomy (S-RARP).
RS-RARP also showed a reduced incidence of inguinal hernias (0.0% vs 13.0%), suggesting that this surgical approach may better preserve pelvic anatomy and improve postoperative quality of life, although further prospective studies are needed to confirm these findings.
Impact of Retzius-sparing Versus Standard Robotic-assisted Radical Prostatectomy on Penile Shortening, Peyronie's Disease, and Inguinal Hernia Sequelae.Kowalczyk, KJ., Davis, M., O'Neill, J., et al.[2022]
The PARTIAL trial is a randomized controlled trial involving 600 men comparing pelvic fascia-sparing robotic-assisted radical prostatectomy (PFS-RARP) to conventional robotic-assisted radical prostatectomy (RARP), focusing on cancer control and functional outcomes over a 24-month period.
If PFS-RARP proves to be as effective as RARP in controlling cancer while offering better recovery of urinary and sexual function, it could become the new standard surgical approach for localized prostate cancer.
Study protocol for a prospective, multi-centered randomized controlled trial comparing pelvic fascia-sparing radical prostatectomy with conventional robotic-assisted prostatectomy: The PARTIAL trial.Stangl-Kremser, J., Kowalczyk, K., Schaeffer, EM., et al.[2023]
The lateral pelvic fascia preservation (LPFP) technique in robot-assisted radical prostatectomy (RARP) significantly shortens the time to urinary continence recovery compared to conventional RARP, as shown in a study of 139 patients.
The LPFP technique also results in shorter operative times and lower blood loss, while maintaining comparable surgical and oncological outcomes, making it a recommended approach for patients with localized prostate cancer.
Improved urinary continence recovery after robot-assisted radical prostatectomy with lateral pelvic fascia preservation.Shiota, M., Tsukahara, S., Ueda, S., et al.[2023]

Citations

Impact of Retzius-sparing Versus Standard Robotic-assisted Radical Prostatectomy on Penile Shortening, Peyronie's Disease, and Inguinal Hernia Sequelae. [2022]
Study protocol for a prospective, multi-centered randomized controlled trial comparing pelvic fascia-sparing radical prostatectomy with conventional robotic-assisted prostatectomy: The PARTIAL trial. [2023]
Improved urinary continence recovery after robot-assisted radical prostatectomy with lateral pelvic fascia preservation. [2023]
[Seminal vesicle sparing radical perineal prostatectomy]. [2021]
Retzius-sparing robot-assisted laparoscopic radical prostatectomy: functional and early oncologic results in aggressive and locally advanced prostate cancer. [2020]
Is It Safe to Switch from a Standard Anterior to Retzius-Sparing Approach in Robot-Assisted Radical Prostatectomy? [2023]
Outcomes and Safety of Suprapubic vs Urethral Catheterization Following Pelvic Fascia Sparing Robotic Prostatectomy. [2023]
Subjective characterization of nerve sparing predicts recovery of erectile function after radical prostatectomy: defining the utility of a nerve sparing grading system. [2011]
Anatomical grades of nerve sparing: a risk-stratified approach to neural-hammock sparing during robot-assisted radical prostatectomy (RARP). [2022]
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