TULSA Procedure vs. Radical Prostatectomy for Prostate Cancer

(CAPTAIN Trial)

Recruiting at 24 trial locations

Overseen By Darshika Mistry

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Profound Medical Inc.

Disqualifiers: Urinary infection, Proctitis, Neurogenic bladder, others

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

Compensation: Varies

Number of Visits: 2

Duration: Immediate

201 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares a new treatment with traditional surgery in men with prostate cancer. The goal is to see if the new treatment can effectively treat cancer while preserving important functions better than surgery. Patients will be followed for several years to assess outcomes. The new treatment is minimally invasive and uses advanced technology to target prostate tissue.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial is for treatment-naïve patients, it suggests that participants should not have received prior treatment for prostate cancer.

What data supports the effectiveness of the TULSA Procedure and Radical Prostatectomy treatment for prostate cancer?

Research shows that robotic-assisted laparoscopic prostatectomy (RALP) is associated with less blood loss, reduced pain, and shorter hospital stays compared to open surgery. Additionally, RALP often results in better urinary control and sexual function after surgery, making it a strong option for treating localized prostate cancer. ^{1 2 3 4 5}

Is the TULSA Procedure or Radical Prostatectomy safe for treating prostate cancer?

Research shows that robot-assisted radical prostatectomy (RARP) is generally safe for treating prostate cancer, with similar safety outcomes to open surgery. Studies indicate that RARP can be performed safely even in high-risk patients and those with previous abdominal surgeries, with no significant increase in complications. ^{6 7 8 9 10}

How does the TULSA Procedure differ from Radical Prostatectomy for prostate cancer treatment?

The TULSA Procedure is a minimally invasive treatment that uses ultrasound to precisely target and destroy prostate tissue, potentially offering less recovery time and fewer side effects compared to traditional radical prostatectomy, which involves surgically removing the prostate gland. ^{4 11 12 13 14}

Eligibility Criteria

Men aged 40-80 with intermediate-risk, localized prostate cancer (Stage ≤T2c, N0, M0) and a life expectancy of over 10 years. Participants must have had a recent biopsy confirming the condition and not undergone any previous treatments for it. Those with certain urinary or anal implants, history of fibrosis or stenosis challenging device insertion, inability to undergo MRI/general anesthesia, or severe bladder conditions cannot join.

Inclusion Criteria

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

PSA ≤20ng/mL within last 3 months

My prostate cancer is classified as ISUP Grade Group 2 or 3.

Exclusion Criteria

I have a history of tightness or blockages in my anal, rectal, or urethral areas that make it hard to insert medical devices.

You have an artificial urinary sphincter, penile implant, or an implant in your prostate.

I am not considered a candidate for major prostate surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the TULSA Procedure or Radical Prostatectomy

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Regular visits at 1, 3, 6, 9, 12, 18, 24 months, and annually up to 10 years

Treatment Details

Interventions

• Radical Prostatectomy
• TULSA Procedure

Trial Overview This study is comparing two procedures in men with prostate cancer: radical prostatectomy (surgery to remove the entire prostate gland) versus TULSA procedure (a less invasive technique using ultrasound). Patients will be randomly assigned to one of these treatments and followed up for 10 years to assess effectiveness and safety.

Participant Groups

Group I: TULSA Procedure Experimental Treatment 1 Intervention

Patients in this group will undergo TULSA Procedure. There will be about 134 people in this group.

Group II: Radical Prostatectomy Active Control 1 Intervention

Patients in this group will undergo Radical prostatectomy. There will be about 67 people in this group.

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?

Profound Medical Inc.

Lead Sponsor

Trials

4

Recruited

1,400+

Findings from Research

All three techniques of radical prostatectomy (open, laparoscopic, and robotic) show low mortality rates and minimal postoperative pain, indicating their safety for patients with localized prostate cancer.

Oncological outcomes are comparable across the techniques, but long-term functional results, particularly regarding sexual function and urinary continence, require further validation, especially for laparoscopic and robotic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radical prostatectomy: open, laparoscopic and robotic. Looking for a new gold standard?]. Martínez-Salamanca, JI., Allona Almagro, A.[2019]

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 comparing 110 robot-assisted laparoscopic prostatectomies (RALP) to laparoscopic prostatectomies (LRP) performed by experienced surgeons, RALP showed comparable outcomes, indicating that prior laparoscopic experience may ease the transition to robotic techniques.

The complication rates were low for both procedures, with no conversions or major injuries, and at 3 months post-surgery, PSA levels were undetectable in 92% of RALP patients, suggesting that RALP is an effective option for treating organ-confined prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the learning curve of experienced laparoscopic surgeons in robot-assisted radical prostatectomy. Stolzenburg, JU., Qazi, HA., Holze, S., et al.[2019]

Robotic-assisted laparoscopic prostatectomy (RALP) is associated with less blood loss, reduced postoperative pain, and shorter hospital stays compared to traditional open surgery, making it a less invasive option for localized prostate cancer treatment.

Postoperative outcomes such as continence and potency are generally better with RALP, although the superiority over traditional radical retropubic prostatectomy remains debated among highly experienced surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted laparoscopic prostatectomy: do minimally invasive approaches offer significant advantages? Smith, JA., Herrell, SD.[2014]

Robot-assisted radical prostatectomy (RARP) in patients with a history of transurethral resection of the prostate (TURP) or open prostatectomy (OP) is associated with longer surgical times and increased blood loss compared to surgery-naive patients, indicating a more complex surgical process.

Patients with prior prostate surgeries experienced higher rates of urinary leakage and anastomotic strictures after RARP, with 12% experiencing urinary leakage and 16% developing strictures, suggesting that previous surgeries may complicate recovery and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Radical Prostatectomy After Previous Prostate Surgery. Tugcu, V., Atar, A., Sahin, S., et al.[2020]

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 6,194 prostate cancer patients, robot-assisted radical prostatectomy (RARP) was associated with a lower rate of positive surgical margins (PSMs) compared to open radical prostatectomy (ORP), particularly in high-risk patients (19.7% vs. 30.1%).

RARP showed no significant difference in PSM rates for low-risk and intermediate-risk patients, but it significantly reduced the odds of PSMs in high-risk patients, suggesting that RARP may be particularly beneficial for those with more aggressive disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of positive surgical margins in patients undergoing robot-assisted and open radical prostatectomy according to preoperative risk groups. Suardi, N., Dell'Oglio, P., Gallina, A., et al.[2016]

Robot-assisted laparoscopic prostatectomy (RALP) demonstrated lower operative time and mean estimated blood loss compared to open radical retropubic prostatectomy (RRP), while also resulting in a shorter hospital stay, indicating improved efficiency and recovery for patients.

Despite these advantages, both RALP and RRP showed comparable rates of complications, positive surgical margins, and functional outcomes such as continence and potency, suggesting that RALP is a safe and effective alternative to traditional open surgery for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic prostatectomy versus open: comparison of the learning curve of a single surgeon. Philippou, P., Waine, E., Rowe, E.[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]

A study comparing 177 patients who underwent open retropubic radical prostatectomy (RRP) and 233 patients who had robot-assisted radical prostatectomy (RARP) found no significant differences in cancer recurrence rates or positive margin rates, indicating that RARP is a safe and effective option for high-risk prostate cancer patients.

Patients who underwent RARP experienced less blood loss and were more likely to have complete bilateral nerve-sparing procedures compared to those who had open RRP, suggesting additional benefits of the robotic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does robot-assisted radical prostatectomy (RARP) compare with open surgery in men with high-risk prostate cancer? Punnen, S., Meng, MV., Cooperberg, MR., et al.[2013]

Robotic-assisted radical prostatectomy (RARP) has become the most popular surgical method for treating localized prostate cancer in the U.S., surpassing open retropubic radical prostatectomy (RRP), which has been the gold standard for over 30 years.

Despite the rapid adoption of RARP, there is ongoing debate about its effectiveness compared to RRP, particularly regarding long-term outcomes and quality of life, as there are no randomized trials or long-term follow-ups exceeding 10 years for RARP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does robotic prostatectomy meet its promise in the management of prostate cancer? Huang, KH., Carter, SC., Hu, JC.[2021]

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]

Robot-assisted radical prostatectomy (RARP) shows promising benefits over traditional open prostatectomy, including reduced blood loss, less pain, quicker recovery, shorter hospital stays, and lower rates of cancer margins, based on current literature.

While RARP demonstrates good outcomes for postoperative continence and potency, the evidence is limited due to a lack of randomized studies, and it has not shown a clear advantage over standard laparoscopic techniques, although it has achieved similar effectiveness within five years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current status of robot-assisted radical prostatectomy. Dasgupta, P., Kirby, RS.[2022]

Robot-assisted laparoscopic radical prostatectomy (RALP) significantly improves the return of erectile function compared to laparoscopic radical prostatectomy (LRP), with a relative risk of 1.51 based on a meta-analysis of 2 studies.

RALP also shows a better rate of return to continence function compared to LRP, with a relative risk of 1.14, indicating that RALP may be more effective in preserving these important quality-of-life factors for patients with localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic versus Robotic-Assisted Radical Prostatectomy for the Treatment of Localised Prostate Cancer: A Systematic Review. Allan, C., Ilic, D.[2018]

References

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[Radical prostatectomy: open, laparoscopic and robotic. Looking for a new gold standard?]. [2019]

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

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

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

Evaluating the learning curve of experienced laparoscopic surgeons in robot-assisted radical prostatectomy. [2019]

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

Robotic-assisted laparoscopic prostatectomy: do minimally invasive approaches offer significant advantages? [2014]

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

Robot-Assisted Radical Prostatectomy After Previous Prostate Surgery. [2020]

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

Evaluation of positive surgical margins in patients undergoing robot-assisted and open radical prostatectomy according to preoperative risk groups. [2016]

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

Robot-assisted laparoscopic prostatectomy versus open: comparison of the learning curve of a single surgeon. [2016]

9. 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]

10. England pubmed.ncbi.nlm.nih.gov

How does robot-assisted radical prostatectomy (RARP) compare with open surgery in men with high-risk prostate cancer? [2013]

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

Does robotic prostatectomy meet its promise in the management of prostate cancer? [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

[Robotic-assisted radical prostatectomy]. [2018]

13. China pubmed.ncbi.nlm.nih.gov

The current status of robot-assisted radical prostatectomy. [2022]

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

Laparoscopic versus Robotic-Assisted Radical Prostatectomy for the Treatment of Localised Prostate Cancer: A Systematic Review. [2018]