Surgical Approaches for Prostate Cancer

(PARTIAL Trial)

Recruiting at3 trial locations

Overseen by Jim C Hu, MD, MPH

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Prior pelvic surgery, radiotherapy, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{2 3 4 8 9}

Research Team

Jim C Hu, MD, MPH

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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 can read and speak English or Spanish.

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)

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

Group I: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) Experimental Treatment 1 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 Control 1 Intervention

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

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved urinary continence recovery after robot-assisted radical prostatectomy with lateral pelvic fascia preservation. Shiota, M., Tsukahara, S., Ueda, S., et al.[2023]

The seminal vesicle sparing radical prostatectomy (SV-RPP) technique resulted in shorter operation times and lower rates of transfusions and anastomotic leaks compared to traditional perineal and retroperitoneal approaches, indicating improved safety during surgery.

SV-RPP also demonstrated better continence rates after 4 weeks and 12 months, while maintaining similar oncological outcomes and PSA relapse rates compared to other surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Seminal vesicle sparing radical perineal prostatectomy]. Schäfers, S., de Geeter, P., Löhmer, H., et al.[2021]

Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) demonstrated significantly better urinary continence outcomes compared to standard anterior RARP (SA-RARP) at all evaluated time points, indicating its efficacy in improving post-surgery quality of life.

While RS-RARP showed a higher rate of positive surgical margins (43% vs. 29% in SA-RARP), this did not negatively impact the one-year biochemical recurrence-free survival rates, suggesting that RS-RARP can be safely implemented without compromising long-term cancer control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is It Safe to Switch from a Standard Anterior to Retzius-Sparing Approach in Robot-Assisted Radical Prostatectomy? Lambert, E., Allaeys, C., Berquin, C., et al.[2023]

In a study of 212 patients who underwent pelvic fascia-sparing robotic-assisted radical prostatectomy, those with suprapubic catheters (SPC) experienced a significantly earlier return to continence (7 days) compared to those with urethral catheters (UC) (16 days).

SPC placement was associated with higher continence rates at the time of catheter removal (67.6% for SPC vs 43.3% for UC), indicating that SPC may enhance patient satisfaction without increasing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and Safety of Suprapubic vs Urethral Catheterization Following Pelvic Fascia Sparing Robotic Prostatectomy. Engelsgjerd, S., Kodres-O'Brien, S., Choudhury, E., et al.[2023]

A study of 173 patients undergoing radical prostatectomy found that a cumulative nerve damage grading system (NSS) is a better predictor of erectile function recovery than the traditional all-or-none grading system, with lower NSS scores correlating with better recovery outcomes.

At 24 months post-surgery, patients with higher NSS grades experienced significantly greater reductions in erectile function scores, indicating that even minor nerve damage can adversely affect recovery, highlighting the need for improved nerve sparing techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjective characterization of nerve sparing predicts recovery of erectile function after radical prostatectomy: defining the utility of a nerve sparing grading system. Moskovic, DJ., Alphs, H., Nelson, CJ., et al.[2011]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of Retzius-sparing Versus Standard Robotic-assisted Radical Prostatectomy on Penile Shortening, Peyronie's Disease, and Inguinal Hernia Sequelae. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. England pubmed.ncbi.nlm.nih.gov

Improved urinary continence recovery after robot-assisted radical prostatectomy with lateral pelvic fascia preservation. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[Seminal vesicle sparing radical perineal prostatectomy]. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Retzius-sparing robot-assisted laparoscopic radical prostatectomy: functional and early oncologic results in aggressive and locally advanced prostate cancer. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Is It Safe to Switch from a Standard Anterior to Retzius-Sparing Approach in Robot-Assisted Radical Prostatectomy? [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Outcomes and Safety of Suprapubic vs Urethral Catheterization Following Pelvic Fascia Sparing Robotic Prostatectomy. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Subjective characterization of nerve sparing predicts recovery of erectile function after radical prostatectomy: defining the utility of a nerve sparing grading system. [2011]

9. England pubmed.ncbi.nlm.nih.gov

Anatomical grades of nerve sparing: a risk-stratified approach to neural-hammock sparing during robot-assisted radical prostatectomy (RARP). [2022]