Robotic Surgery for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

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

Compensation: Varies

Number of Visits: Unknown

1531 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.

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

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 Radical Prostatectomy for prostate cancer?

Research shows that robotic-assisted radical prostatectomy, a minimally invasive surgery for prostate cancer, has improved functional outcomes and fewer complications compared to traditional open surgery. Studies also highlight technical improvements over time that enhance patient satisfaction and maintain cancer control. ^{1 2 3 4 5}

Is robotic surgery for prostate cancer safe?

Robotic prostate surgery is generally safe, with most issues being equipment malfunctions that are usually fixable and rarely cause harm to patients. A review of reported incidents found that out of 602 cases, only 53 involved patient injuries, and no deaths were linked to robot malfunctions. ^{6 7 8 9 10}

How is robotic radical prostatectomy different from other treatments for prostate cancer?

Robotic radical prostatectomy is unique because it uses a robot to assist in the surgery, which improves precision and accuracy compared to traditional methods. This approach is particularly beneficial for performing complex procedures like prostate removal with minimal invasiveness. ^{11 12 13 14 15}

Research Team

Steven Clinton, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for men aged 18 or older with prostate cancer who are either scheduled to undergo or have already undergone robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, Ohio State University Medical Center.

Inclusion Criteria

I am over 18, have prostate cancer, and will have surgery at The Arthur G. James Cancer Hospital.

I had prostate cancer surgery at The Arthur G. James Cancer Hospital and am willing to sign consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical

Collection and analysis of presurgical data for patients undergoing robotic radical prostatectomy

Varies

Peri-operative

Collection and analysis of peri-operative data during robotic radical prostatectomy

1 week

Follow-up

Participants are monitored for surgical outcomes and effectiveness after the procedure

6 months

Treatment Details

Interventions

• Robotic Radical Prostatectomy

Trial Overview The study is analyzing the surgical outcomes of patients who have had their prostates removed using a robot-assisted technique known as robotic radical prostatectomy.

Participant Groups

Group I: Arm B Experimental Treatment 1 Intervention

Patients with prostate cancer that will undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center .

Group II: Arm A Active Control 1 Intervention

Patients with prostate cancer who have undergone robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Findings from Research

Robot-assisted laparoscopic radical prostatectomy (RALP) has similar positive surgical margin rates compared to traditional open and laparoscopic surgeries, indicating its safety and effectiveness in treating organ-confined prostate cancer.

While RALP shows excellent short-term oncological control, long-term outcomes such as biochemical disease-free survival are still unclear, highlighting the need for larger studies with extended follow-up to fully assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radical robot prostatectomy: oncological outcomes]. Rodríguez, E., Skarecky, DW., Ahlering, TE.[2007]

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]

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]

In a study of 210 patients undergoing robotic radical prostatectomy, 26% experienced complications, with 87% classified as minor, indicating a generally low morbidity associated with this surgical method.

The complication rate for robotic surgery appears to be lower than that of traditional open radical prostatectomy, suggesting that robotic techniques may offer safer outcomes as surgeons gain experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of robotic assisted radical prostatectomy. Fischer, B., Engel, N., Fehr, JL., et al.[2022]

Robotic radical prostatectomy has been established as a feasible and effective method for treating localized prostate cancer in young patients, improving precision and accuracy compared to traditional laparoscopic techniques.

The review focuses on the European experience, highlighting advancements in robotic technology that enhance surgical outcomes for patients undergoing this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic radical prostatectomy: the European experience. Cathelineau, X., Rozet, F., Vallancien, G.[2004]

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]

References

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

Evolution of robotic radical prostatectomy: assessment after 2766 procedures. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

[Radical robot prostatectomy: oncological outcomes]. [2007]

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

Incremental modification of robotic prostatectomy technique can lead to aggregated marginal gains to significantly improve functional outcomes without compromising oncological control. [2022]

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

Salvage Radical Prostatectomy for Recurrent Prostate Cancer: Morbidity and Functional Outcomes from a Large Multicenter Series of Open versus Robotic Approaches. [2020]

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

Robot-assisted radical prostatectomy: advances since 2005. [2010]

6. England pubmed.ncbi.nlm.nih.gov

Patient injuries and malfunctions associated with robotic prostatectomy: review of the manufacturer and user facility device experience database. [2021]

7. 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]

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

Clavien classification of complications after the initial series of robot-assisted radical prostatectomy: the Cancer Institute of New Jersey/Robert Wood Johnson Medical School experience. [2022]

9. India pubmed.ncbi.nlm.nih.gov

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

10. Germany pubmed.ncbi.nlm.nih.gov

Complications of robotic assisted radical prostatectomy. [2022]

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

Technique of da Vinci robot-assisted anatomic radical prostatectomy. [2022]

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

Robotic radical prostatectomy: the European experience. [2004]

13. Czech Republic pubmed.ncbi.nlm.nih.gov

[Robotic-assisted radical prostatectomy - results of 1500 surgeries]. [2019]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Structured and Modular Training Pathway for Robot-assisted Radical Prostatectomy (RARP): Validation of the RARP Assessment Score and Learning Curve Assessment. [2022]

15. Cyprus pubmed.ncbi.nlm.nih.gov

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