Surgical Approaches for Prostate Cancer

(PARTIAL Trial)

Recruiting at 5 trial locations

Overseen By Xiaohong Jing, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Prior pelvic surgery, radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two surgical approaches for treating prostate cancer: a new method called pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) and the standard robot-assisted radical prostatectomy (RP). Researchers seek to determine if the new method provides the same cancer control while improving recovery aspects like urinary function and reducing risks of complications such as penile shortening. Men with localized prostate cancer who are planning surgery might be suitable candidates for this trial. As an unphased trial, this study allows patients to contribute to innovative surgical advancements that may enhance recovery and 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 prior data suggests that these surgical approaches are safe for prostate cancer treatment?

Research has shown that pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) is generally well-tolerated. Studies have found that this surgical method can improve urinary control and quality of life for up to two years after surgery without compromising cancer treatment. Patients may experience less urine leakage compared to the standard procedure.

The standard robot-assisted radical prostatectomy (RP) is the most common surgery for prostate cancer. It has been widely used and studied, demonstrating a strong safety record.

Both surgeries aim to remove the prostate, but PFS-RP preserves more of the surrounding supportive tissues, potentially leading to better urinary function. In terms of safety, both procedures have been tested on many patients and meet current medical safety standards. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) because it offers a novel way to treat prostate cancer while preserving critical structures like the nerves and fascial support around the prostate. Unlike the standard robot-assisted radical prostatectomy (RP), which typically involves removing these structures, PFS-RP aims to protect them, potentially reducing side effects related to nerve damage. This innovative approach could improve post-surgery recovery and quality of life for patients by maintaining important functions that are often compromised by conventional methods.

What evidence suggests that these surgical approaches could be effective for prostate cancer?

This trial will compare two surgical approaches for prostate cancer: pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) and the standard robot-assisted radical prostatectomy (RP). Research has shown that PFS-RP can improve urinary function and quality of life without compromising cancer control. Specifically, studies have found that patients experience better urinary control for up to two years after this surgery compared to the traditional method. This approach preserves important tissues around the prostate, leading to better outcomes. The ability to control cancer remains effective with this technique. Overall, PFS-RP may provide similar cancer control while offering added benefits for urinary function and quality of life. ^{2 3 4 6 7}

Who Is on the Research Team?

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 between 40 and 80 years old.

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?

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+

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

In a study of 50 men with high-risk prostate cancer who underwent Retzius-sparing robot-assisted laparoscopic radical prostatectomy (rsRARP), 98% of patients were pad-free or using only one safety pad by 12 months post-surgery, indicating excellent early recovery of urinary continence.

The 1-year recurrence-free survival rate was 96%, suggesting that rsRARP is not only feasible but also effective in managing high-risk prostate cancer, although further studies are needed to confirm long-term oncologic outcomes and sexual recovery rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retzius-sparing robot-assisted laparoscopic radical prostatectomy: functional and early oncologic results in aggressive and locally advanced prostate cancer. Nyarangi-Dix, JN., Görtz, M., Gradinarov, G., et al.[2020]

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]

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 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]

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]

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]

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]

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]

In a study of 1263 patients who underwent robot-assisted radical prostatectomy, a risk-stratified approach to nerve-sparing techniques significantly improved rates of sexual function recovery, with 90.9% of patients in the highest nerve-sparing grade returning to successful intercourse.

The technique did not compromise cancer control, as positive surgical margin rates remained low and consistent across different nerve-sparing grades, indicating that improved potency outcomes can be achieved without increasing the risk of cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical grades of nerve sparing: a risk-stratified approach to neural-hammock sparing during robot-assisted radical prostatectomy (RARP). Tewari, AK., Srivastava, A., Huang, MW., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1078143923004180

Long-term outcomes of pelvic-fascia sparing robotic ... Our study demonstrates that PFS-RARP significantly improves long-term urinary function and overall quality of life. •. Our data suggest that cancer control with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38212151/

Long-term outcomes of pelvic-fascia sparing robotic ... PFS-RARP improves continence and patient-reported QOL up to 24 months postoperatively without compromising oncologic outcomes.

3. oaepublish.com oaepublish.com/articles/2574-1225.2024.121

Outcomes after pelvic fascia-sparing robot-assisted radical ... Urinary incontinence immediately following robotic-assisted laparoscopic radical prostatectomy can significantly impact quality of life.

4. urotoday.com urotoday.com/conference-highlights/suo-2023/suo-2023-prostate-cancer/148269-suo-2023-current-advances-in-robotic-prostatectomy.html

SUO 2023: Current Advances in Robotic Prostatectomy The Retzius-sparing approach has been developed over the last decade in an attempt to improve post-operative functional outcomes, mainly immediate urinary ...

5. uncmedicalcenter.org uncmedicalcenter.org/app/files/public/5a220a46-16e6-4869-bbd3-73f71621d9d4/pdf-medctr-Tan-Pelvic-Health-Symposium-2025.pdf

Robotic Prostatectomy and its Impact on Urinary and ... Contemporary Outcomes Data. Egan et al. Retzius-sparing Robot-assisted Radical Prostatectomy. Leads to Durable Improvement in Urinary Function ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37015291/

The PARTIAL trial We describe a prospective RCT with a projected enrollment of 600 men randomized to PFS-RARP vs. RARP. The primary outcome is cancer control.

7. mdpi.com mdpi.com/2072-6694/17/19/3122

The Role of Robot-Assisted Radical Prostatectomy in ... This review summarizes the current evidence on the efficacy, safety, and functional outcomes associated with RARP and discusses its role in contemporary ...