Robotic Surgery for Prostate Cancer

Overseen By Ileana Aldana

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Psychiatric, Neurologic, Cognitive, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1-2 weeks

196 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a type of surgery called robot-assisted radical prostatectomy (RARP) for men with localized prostate cancer. Researchers aim to determine if adding vesicopexy, a technique that helps reposition the bladder, can improve bladder control and quality of life post-surgery. The study includes two groups: one receives RARP with vesicopexy, and the other receives RARP without it. Men with prostate cancer who can control their bladder before surgery might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative surgical techniques that could enhance recovery and quality of life for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this surgical technique is safe for prostate cancer patients?

Research shows that robotic-assisted radical prostatectomy (RARP), the main treatment under study, is generally safe for patients. Studies have found that this type of surgery usually results in few complications. While all surgeries carry some risks, RARP tends to have fewer side effects than traditional methods.

Another technique under study is vesicopexy, which aims to improve bladder control after surgery. Although specific safety data on vesicopexy is lacking, it is part of the robotic surgery and is intended to aid recovery and enhance quality of life.

Overall, robotic surgery for prostate cancer has been well-researched and is widely used, indicating it is well-tolerated by most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores robotic-assisted radical prostatectomy (RARP) with an innovative twist—vesicopexy. Vesicopexy is a technique that may improve urinary function by securing the bladder to the pelvic wall, potentially enhancing recovery after prostate surgery. While traditional RARP focuses solely on removing the prostate, this study examines whether adding vesicopexy offers better post-operative outcomes. By comparing the standard RARP with and without vesicopexy, researchers hope to determine if this method can lead to quicker recovery and improved quality of life for patients.

What evidence suggests that this trial's treatments could be effective for improving urinary continence and quality of life in prostate cancer patients?

Research has shown that using robotic surgery to remove the prostate, along with a technique called vesicopexy, can greatly improve bladder control in prostate cancer patients. One study found that 86.8% of patients regained bladder control within a year, and 90.8% did so within three years. Vesicopexy helps position the bladder correctly after surgery, potentially leading to better results. In this trial, participants in Arm I will undergo robotic surgery with vesicopexy, while those in Arm II will have robotic surgery without it. Patients who undergo this robotic surgery typically experience good cancer control and an improved quality of life. These findings suggest that adding vesicopexy might enhance bladder control compared to robotic surgery alone. ^{4 6 7 8 9}

Who Is on the Research Team?

Hooman Djaladat, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for men over 18 with non-metastatic prostate cancer who are undergoing robot-assisted surgery at USC urology. They must be able to consent, have a good performance status (ECOG score 0-1), and control their bladder before the operation. Men with psychiatric, neurological conditions, neuropathic bladder issues, or substance addictions cannot participate.

Inclusion Criteria

I have never had radiation or local therapy for prostate cancer.

I am a prostate cancer patient scheduled for RARP with an anterior approach at USC.

My prostate cancer is in an early stage and has not spread.

Exclusion Criteria

I have a history of bladder nerve damage.

Any drug or alcohol addiction

Any history of psychiatric, neurologic or cognitive disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo standard RARP with or without vesicopexy. Urethral catheters are removed 7-14 days following surgery.

1-2 weeks

1 visit (in-person for surgery)

Follow-up

Participants are monitored for urinary continence, quality of life, and sexual function at 24 hours, 1 month, and 3 months post-operative.

3 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Radical Prostatectomy
• Vesicopexy

Trial Overview The study compares two surgical methods: robot-assisted radical prostatectomy alone versus the same procedure with an additional technique called vesicopexy. The goal is to see if adding vesicopexy improves bladder control and quality of life after surgery for prostate cancer patients.

How Is the Trial Designed?

Group I: Arm I (radical prostatectomy, vesicopexy) Experimental Treatment 4 Interventions

Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.

Group II: Arm II (radical prostatectomy) Active Control 3 Interventions

Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.

Radical Prostatectomy is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Radical Prostatectomy for:

• Prostate cancer

Approved in United States as Radical Prostatectomy for:

• Prostate cancer

Approved in Canada as Radical Prostatectomy for:

• Prostate cancer

Approved in Japan as Radical Prostatectomy for:

• Prostate cancer

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Robot-assisted laparoscopic radical prostatectomy (RALP) offers better functional outcomes, such as improved continence and potency rates, and reduces blood loss compared to open radical prostatectomy (ORP).

While RALP shows a lower incidence of positive surgical margins, its effectiveness in treating nonorgan-confined prostate cancer remains unclear, and long-term oncologic outcomes are comparable to those of ORP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Robotic-assisted radical prostatectomy]. Thomas, C., Neisius, A., Roos, FC., et al.[2018]

Using the Aalst technique for robot-assisted radical prostatectomy (RARP), patients can safely have their catheters removed just 2 days after surgery, showing no increase in urinary leakage or negative effects on pain levels.

Early catheter removal did not lead to higher rates of urinary retention, and patients experienced spontaneous voiding, suggesting that this approach could enhance recovery and comfort for patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Catheter Removal after Robot-assisted Radical Prostatectomy: Surgical Technique and Outcomes for the Aalst Technique (ECaRemA Study). Gratzke, C., Dovey, Z., Novara, G., et al.[2022]

In a study of 251 elderly men (≥70 years old) who underwent either open retropubic radical prostatectomy (ORRP) or robot-assisted radical prostatectomy (RARP), the rates of major complications were similar for both surgical methods, at 4.7% for ORRP and 4.9% for RARP.

Both surgical approaches resulted in comparable continence rates after 24 months (78.5% for ORRP vs. 79.4% for RARP), but the rates of erectile function remained low, indicating that while safety is similar, functional outcomes may still be a concern for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative adverse events and functional outcomes following open and robot-assisted prostatectomy in patients over age 70. Sancı, A., Özkaya, MF., Oguz, ES., et al.[2021]

Robotic-assisted laparoscopic prostatectomy (RALP) demonstrated high safety with no conversions to open surgery or re-operations in the first 100 cases studied, with an average blood loss of only 281 ml and a short hospital stay of 1.1 nights.

Efficacy results showed an 18% positive margin rate overall, with only 8% for pT2 tumors, and 68% of patients reported no incontinence at 12 months, indicating RALP is effective in managing prostate cancer with favorable postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic prostatectomy: a 2010 update. Duthie, JB., Pickford, JE., Gilling, PJ.[2011]

Surgeons typically need to perform between 18 to 45 robotic-assisted radical prostatectomy (RARP) procedures to reach a plateau in their learning curve, indicating a significant amount of practice is required for proficiency.

The most effective training model for RARP includes a combination of virtual reality simulations, observational learning, and supervised practice, which helps surgeons learn and analyze their techniques effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Methods for training of robot-assisted radical prostatectomy]. Rapoport, LM., Bezrukov, EA., Tsarichenko, DG., et al.[2019]

Robotic-assisted radical prostatectomy (RARP) shows promising oncological outcomes with a low biochemical recurrence rate of 6.9% over a follow-up period of up to 55 months, indicating its effectiveness in treating localized and locally advanced prostate cancer.

Functional outcomes are also favorable, with continence rates improving to 93.7% and sexual function restoration reaching 53% by 55 months post-surgery, demonstrating the procedure's safety and potential for maintaining quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted radical prostatectomy - the 5-year Romanian experience. Logigan, H., Andras, I., Pop, CD., et al.[2015]

A study of 66,683 patients who underwent robotic-assisted radical prostatectomy (RARP) from 2011 to 2019 showed that the procedure is increasingly being performed on older and frailer patients without an increase in postoperative morbidity or mortality.

Despite the rising frailty in the patient population, the operative time and length of hospital stay for RARP have decreased, indicating improved efficiency of the procedure over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted radical prostatectomy is pushing the boundaries: a national survey of frailty using the national surgical quality improvement program. Abou Heidar, NF., Ayoub, CH., Abou Mrad, A., et al.[2023]

Laparoscopic radical prostatectomy, whether performed purely or with robotic assistance, shows similar oncologic and functional outcomes compared to traditional open radical prostatectomy, making it a viable alternative for localized prostate cancer treatment.

This minimally invasive approach results in less blood loss and shorter recovery times, although the costs for robotic-assisted procedures are higher due to initial investments and maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pure laparoscopic and robotic-assisted laparoscopic radical prostatectomy in the management of prostate cancer. Pow-Sang, JM., Velasquez, J., Myers, MD., et al.[2017]

In a study of 5,923 men aged 66 and older with localized prostate cancer, laparoscopic prostatectomy showed similar rates of postoperative complications and additional cancer treatments compared to open radical prostatectomy, indicating comparable safety and efficacy between the two surgical approaches.

However, laparoscopic prostatectomy was associated with a significantly shorter hospital stay (35% less) and a lower rate of bladder neck/urethral obstruction, suggesting potential advantages in recovery time and certain complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of prostate cancer surgical treatments: a population based analysis of postoperative outcomes. Lowrance, WT., Elkin, EB., Jacks, LM., et al.[2021]

Robot-assisted radical prostatectomy (RARP) is a safe and effective treatment for localized prostate cancer, showing no significant differences in operative time, complication rates, or oncological outcomes between patients with and without previous abdominal surgery, based on a study of 339 patients.

Both groups had similar biochemical recurrence-free survival rates and high continence rates, with potency recovery rates of 69.5% for patients without prior surgery and 62.2% for those with prior surgery, indicating that previous abdominal surgery does not adversely affect functional outcomes after RARP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted radical prostatectomy in the setting of previous abdominal surgery: Perioperative results, oncological and functional outcomes, and complications in a single surgeon's series. Di Pierro, GB., Grande, P., Mordasini, L., et al.[2018]

Robot-assisted laparoscopic prostatectomy (RARP) has shown safety and efficacy comparable to the traditional open radical prostatectomy (RRP) for treating localized prostate cancer, based on a systematic review of 226 relevant studies published between 1997 and 2008.

Despite the promising results, further prospective and randomized studies are needed to definitively compare the long-term outcomes of RARP and RRP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of robot-assisted radical prostatectomy. Orvieto, MA., Patel, VR.[2018]

In a study involving 1,094 men with localized prostate cancer across 11 academic medical centers, robot-assisted laparoscopic prostatectomy (RALP) resulted in significantly less intraoperative blood loss, shorter hospital stays, and fewer complications compared to open radical prostatectomy (ORP).

Despite these advantages, both surgical approaches (RALP and ORP) showed similar long-term health-related quality of life outcomes, indicating that patients can expect comparable overall satisfaction regardless of the surgical method used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Multicenter Comparison of Open and Robotic Radical Prostatectomy: The PROST-QA/RP2 Consortium. Chang, P., Wagner, AA., Regan, MM., et al.[2023]

In a study of 100 patients undergoing robot-assisted laparoscopic prostatectomy (RALP) for localized prostate cancer, the procedure showed a positive trend in improving operative time and estimated blood loss as the learning curve progressed, indicating enhanced surgical efficiency.

At the last follow-up, 88% of patients had undetectable PSA levels, and 80% were not using pads, demonstrating that RALP is effective in achieving good cancer control and maintaining quality of life even during the initial learning phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic prostatectomy: the first 100 patients-improving patient safety and outcomes. Tsao, AK., Smaldone, MD., Averch, TD., et al.[2016]

In a study of 317 patients undergoing robotic radical prostatectomy (RARP) at a medium-volume center, 30.3% experienced complications, mostly minor (84.4% classified as Clavien grade 1 and 2), indicating a generally high safety profile for the procedure.

The nerve-sparing surgical technique was identified as an independent predictor of complications, suggesting that while it may be beneficial for preserving function, it could also increase the risk of postoperative issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current evidence between hospital volume and perioperative outcome: Prospective assessment of robotic radical prostatectomy safety profile in a regional center of medium annual caseload. Ferrari, M., Mazzola, B., Roggero, E., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9782116/

Comparative Outcomes of Robotic Radical Prostatectomy ... Sixty-six patients (86.8%) regained continence within 1 year, and the continence rate at 3 years of follow-up was 90.8%. Table 2. Perioperative outcomes for ...

2. nature.com nature.com/articles/s41598-025-21851-4

The early therapeutic efficacy of robot-assisted ... This study aims to compare the perioperative outcomes, postoperative urinary control rates, and positive surgical margin (PSM) rates of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2588931123001682

Prostate Cancer–specific and All-cause Mortality After ... In the present study, we reported the outcomes of patients with prostate cancer (PCa) who underwent robot-assisted radical prostatectomy between 10 and 20 yr ...

4. europeanurology.com europeanurology.com/article/S0302-2838(25)00180-0/fulltext

Outcomes of Salvage Robotic-assisted Radical ... Salvage robotic-assisted radical prostatectomy is a safe and viable option with minimal perioperative complications, although functional ...

5. link.springer.com link.springer.com/article/10.1007/s00066-023-02192-5

Six-year outcomes of robot-assisted radical prostatectomy ... In this study using PSM after a 6-year follow-up, RARP and VMAT showed equivalent and excellent oncological outcomes, as well as acceptable ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37353415/

Robot-assisted Versus Conventional Laparoscopic Radical ... We analysed differences between robot-assisted removal of the prostate and conventional keyhole surgery for removal of the prostate.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2588931125001270

Robotic Versus Open Radical Prostatectomy, Differences ... At 12 yr after surgery, prostate cancer–specific mortality was significantly lower in patients undergoing robotic prostatectomy than in those undergoing open ...

8. nature.com nature.com/articles/s41598-023-34864-8

Outcomes of prostate cancer patients after robot-assisted ... The study included 15,501 patients with PCa who underwent RARP (n = 12,268) or radical prostatectomy (RP) (n = 3,233) between 2009 and 2017. The ...

9. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12855-w

a prospective, controlled, randomized clinical trial Radical prostatectomy (RP) is recommended as the first-line management for intermediate to high-risk localized prostate cancer (PCa) [1]. With ...