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

Trial Summary

What is the purpose of this trial?

This phase III trial compares the effects of robot-assisted radical prostatectomy (RARP) with or without vesicopexy on urinary continence (a person's ability to control their bladder) and quality of life in patients with cancer of the prostate. RARP is the most adopted surgical approach for treatment of prostate cancer that has not spread to other places in the body (non-metastatic). Urinary incontinence (inability to control the bladder) is one of the most common complications of RARP, impacting patients' quality of life and psychological well-being. Different techniques have been proposed to improve urinary continence following RARP. Vesicopexy is one technique that restores the bladder to its normal position in the body after RARP. This study aims to evaluate whether RARP with vesicopexy may improve urinary continence and quality of life after surgery in prostate cancer 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 data supports the effectiveness of the treatment Robotic Surgery for Prostate Cancer?

Research shows that robotic-assisted radical prostatectomy (RARP) often results in better functional and cancer-related outcomes, with less blood loss compared to traditional open surgery. It is also considered favorable for patients who are more frail, indicating its effectiveness in a wider range of patients. ^{1 2 3 4 5}

Is robotic surgery for prostate cancer generally safe for humans?

Research shows that robotic surgery for prostate cancer, known as robot-assisted radical prostatectomy (RARP), has been studied for safety in various settings, including patients with previous surgeries and older patients. These studies generally focus on safety outcomes, such as complications during and after surgery, and suggest that RARP is considered safe in these contexts. ^{6 7 8 9 10}

How is the treatment robotic-assisted radical prostatectomy (RARP) different from other treatments for prostate cancer?

Robotic-assisted radical prostatectomy (RARP) is a minimally invasive surgery that uses robotic technology to assist surgeons, offering potentially better precision and outcomes compared to traditional open surgery. It is increasingly popular due to its ability to be used in frailer patients and its growing acceptance among urologists worldwide. ^{2 11 12 13 14}

Research Team

Hooman Djaladat, MD

Principal Investigator

University of Southern California

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

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

Prospective Multicenter Comparison of Open and Robotic Radical Prostatectomy: The PROST-QA/RP2 Consortium. [2023]

2. England 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. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[Robotic-assisted radical prostatectomy]. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Early Catheter Removal after Robot-assisted Radical Prostatectomy: Surgical Technique and Outcomes for the Aalst Technique (ECaRemA Study). [2022]

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

Comparative effectiveness of prostate cancer surgical treatments: a population based analysis of postoperative outcomes. [2021]

6. United States 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. [2018]

7. India pubmed.ncbi.nlm.nih.gov

Perioperative adverse events and functional outcomes following open and robot-assisted prostatectomy in patients over age 70. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic prostatectomy: a 2010 update. [2011]

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

Robot-assisted laparoscopic prostatectomy: the first 100 patients-improving patient safety and outcomes. [2016]

10. Canada 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. [2021]

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

Pure laparoscopic and robotic-assisted laparoscopic radical prostatectomy in the management of prostate cancer. [2017]

12. Cyprus pubmed.ncbi.nlm.nih.gov

Robotic-assisted radical prostatectomy - the 5-year Romanian experience. [2015]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Methods for training of robot-assisted radical prostatectomy]. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Evolution of robot-assisted radical prostatectomy. [2018]