Robotic Surgery for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: None

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the outcomes of robotic surgery for prostate cancer, focusing on a procedure called robotic radical prostatectomy. This surgery removes the prostate using robotic technology for precision. Participants fall into two groups: those who have already undergone the surgery and those scheduled to have it soon. It suits individuals with prostate cancer who are receiving or have received this robotic surgery at The Ohio State University Medical Center. As an unphased trial, it offers a unique opportunity to advance surgical techniques and improve patient outcomes.

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 prior data suggests that robotic radical prostatectomy is safe for prostate cancer patients?

Research has shown that robotic radical prostatectomy, a surgery using robotic tools to remove the prostate, is generally safe and well-tolerated. In a study of 500 patients, 95% showed no signs of cancer in their blood about 10 months after the surgery, suggesting short-term effectiveness and safety. Another study found that 12 years after surgery, patients who underwent robotic prostate surgery had a lower mortality rate from prostate cancer compared to those who had traditional open surgery. Overall, these studies support the safety of robotic radical prostatectomy for prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Robotic radical prostatectomy is unique because it offers a minimally invasive approach to prostate cancer surgery, leveraging robotic technology for precision. Unlike traditional open surgery, which involves larger incisions and longer recovery times, this method uses smaller incisions, potentially leading to less pain and faster recovery. Researchers are excited about this technique because it aims to enhance surgical accuracy, potentially improving outcomes by reducing the risk of complications and preserving important functions like urinary control and sexual health.

What evidence suggests that robotic radical prostatectomy is effective for prostate cancer?

Studies have shown positive results for robotic surgery in treating prostate cancer. One study found that 86.8% of patients regained control over urination within one year, increasing to 90.8% after three years. Research also shows good survival rates for patients with low- and intermediate-risk prostate cancer. Specifically, the overall survival rate at five years was reported to be as high as 95%. This trial will evaluate robotic radical prostatectomy, and these findings suggest that robotic surgery can effectively manage prostate cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Steven Clinton, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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/s41598-023-34864-8

Outcomes of prostate cancer patients after robot-assisted ... A significantly higher short-term mortality and only modestly lower surgical complications occurred in RARP than RP group.

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

Prostate Cancer–specific and All-cause Mortality After ... Our multicenter study with long-term follow-up confirms favorable survival outcomes after RARP for localized PCa. Patients with low- and intermediate-risk ...

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

Outcomes of Salvage Robotic-assisted Radical ... The 5-yr cumulative incidence rates of potency were 16%, 11%, and 5.3% (p = 0.2), while the overall survival rates at 5 yr were 95%, 94%, and ...

5. urotoday.com urotoday.com/library-resources/localized-prostate-cancer/141857-the-impact-of-surgeon-experience-and-volume-on-patient-outcomes-in-radical-prostatectomy-patients.html

The Impact of Surgeon Experience and Volume on Patient ... Positive surgical margin rates were compared before and after the intervention. The aggregated departmental positive surgical margin rates improved from 10.6% ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40210552/

Outcomes of Salvage Robotic-assisted Radical ... The 5-yr cumulative incidence rates of potency were 16%, 11%, and 5.3% (p = 0.2), while the overall survival rates at 5 yr were 95%, 94%, and ...

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

Feasibility, safety and effectiveness of robot-assisted radical ... The short-term oncologic efficacy of RARP was also compared between the two robotic systems. Our results did not demonstrate a significant ...

8. 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 after RALP than after RRP (55/2698 [2.0%] vs 40/885 [4.5%]; ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17437441/

Robotic radical prostatectomy: outcomes of 500 cases The overall biochemical recurrence free (PSA level<0.1 ng/mL) survival was 95% at mean follow-up of 9.7 months. There was complete continence at 3 and 6 months ...