Robotic Surgery for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Overseen byHooman Djaladat, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Southern California
Disqualifiers: Psychiatric, Neurologic, Cognitive, others
No Placebo Group
Approved in 5 Jurisdictions
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.
12345Is 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.
678910How 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.
211121314Eligibility 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.
+4 more
Exclusion Criteria
I have a history of bladder nerve damage.
Any drug or alcohol addiction
Any history of psychiatric, neurologic or cognitive disease
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (radical prostatectomy, vesicopexy)Experimental Treatment4 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 Control3 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, Australia 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
🇦🇺 Approved in Australia as Radical Prostatectomy for:
- Prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
USC / Norris Comprehensive Cancer CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
University of Southern CaliforniaLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Prospective Multicenter Comparison of Open and Robotic Radical Prostatectomy: The PROST-QA/RP2 Consortium. [2023]Our goal was to evaluate the comparative effectiveness of robot-assisted laparoscopic prostatectomy (RALP) and open radical prostatectomy (ORP) in a multicenter study.
Robotic-assisted radical prostatectomy is pushing the boundaries: a national survey of frailty using the national surgical quality improvement program. [2023]Robotic-assisted radical prostatectomy (RARP) has been found to be comparable and, in some cases, favorable to open surgical approaches, while being used in a frailer population.
[Robotic-assisted radical prostatectomy]. [2018]Robot-assisted laparoscopic radical prostatectomy (RALP) has been rapidly adopted as a standard approach for surgical treatment of organ-confined prostate cancer. Despite additional costs, RALP seems to provide better functional and oncological outcomes and less blood loss compared to open radical prostatectomy (ORP). However, prospective randomized studies are still missing.
Early Catheter Removal after Robot-assisted Radical Prostatectomy: Surgical Technique and Outcomes for the Aalst Technique (ECaRemA Study). [2022]Robot-assisted radical prostatectomy (RARP) is a widespread option for the treatment of patients with clinically localised prostate cancer. Modifications in the surgical technique may help to further improve functional outcomes.
Comparative effectiveness of prostate cancer surgical treatments: a population based analysis of postoperative outcomes. [2021]Enthusiasm for laparoscopic surgical approaches to prostate cancer treatment has grown despite limited evidence of improved outcomes compared with open radical prostatectomy. We compared laparoscopic prostatectomy with or without robotic assistance vs open radical prostatectomy in terms of postoperative outcomes and subsequent cancer directed therapy.
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]Data on safety and efficacy of robot-assisted radical prostatectomy (RARP) after previous abdominal surgery are scarce. Hence, we assessed perioperative, oncological and functional outcomes, and complications of RARP in patients with previous abdominal surgery after 1-year minimum follow-up.
Perioperative adverse events and functional outcomes following open and robot-assisted prostatectomy in patients over age 70. [2021]To evaluate the safety (perioperative adverse events) of robot-assisted radical prostatectomy (RARP) and functional outcomes (continence and erectile dysfunction) of open and robotic radical prostatectomy in elderly patients.
Robot-assisted laparoscopic prostatectomy: a 2010 update. [2011]To build on the previous article and further explore the safety and efficacy of robotic-assisted laparoscopic prostatectomy (RALP) in the first 100 cases from a single institution in New Zealand.
Robot-assisted laparoscopic prostatectomy: the first 100 patients-improving patient safety and outcomes. [2016]Patient safety and outcomes are paramount when using new technology. We report our initial experience of 100 patients with robot-assisted laparoscopic prostatectomy (RALP) with a focus on patient safety and outcomes.
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]We aimed to present the safety profile of robotic radical prostatectomy (RARP) performed in a single center of medium surgical volume since its introduction and identify predictors of postoperative complications.
Pure laparoscopic and robotic-assisted laparoscopic radical prostatectomy in the management of prostate cancer. [2017]Until recently, open radical prostatectomy was the only approach for the surgical management of prostate cancer. Laparoscopy is now increasingly used as an alternative approach. The procedure can be performed directly or with robot assistance.
Robotic-assisted radical prostatectomy - the 5-year Romanian experience. [2015]Radical prostatectomy is the standard therapeutic approach for localized prostate cancer. After the implementation of robotic surgery in Romania, the indication extended progressively to locally advanced prostate cancer. Our objective was to evaluate the oncological and functional outcomes in patients undergoing robotic-assisted radical prostatectomy (RARP), 5 years after the first intervention in Romania.
[Methods for training of robot-assisted radical prostatectomy]. [2019]Robotic surgery is a future method of minimal invasive surgery. Robot-assisted radical prostatectomy (RARP) is a common method of surgical treatment of prostate cancer. Due to significant differences of the surgical technique of RARP compared to open or laparoscopic radical prostatectomy (LRP) new methods of training are needed. At the moment there are many opinions how to train physicians best. Which model is the most effective one remains nowadays controversial.
Evolution of robot-assisted radical prostatectomy. [2018]Open radical prostatectomy (RRP) is the gold standard and most widespread treatment for clinically localized prostate cancer. However, in recent years robot-assisted laparoscopic prostatectomy (RARP) is rapidly gaining acceptance among urologists worldwide. We sought to outline our surgical technique of robotic radical prostatectomy and provide practical recommendations based on available reports and personal experience. We also critically review the current experience on RARP worldwide and compare the available data with the gold standard open RRP series.