Innovative Study will Compare Open and Robotic Prostatectomy
By Joanna Shea O'Brien
Beth Israel Deaconess Medical Center correspondent
An estimated 240,000 American men will be diagnosed with prostate cancer this year. Not all men will need or elect to have a prostatectomy (surgery to remove the prostate gland), but for those that do, having a clear understanding of possible post-surgery outcomes, such as sexual and urinary function, is critical.
A consortium of nine medical centers have begun enrollment in a new clinical trial, which will compare robot-assisted and open prostatectomy. The study, which is funded by the
National Institutes of Health, will focus on outcomes for patient recovery, cancer control, sexual and urinary function, and overall satisfaction with treatment. This study is particularly innovative because it relies on patients' responses on a wide range of topics, and also involves follow-up phone interviews over a period of time, third party surveys and validated questionnaires.
Martin Sanda, MD, Director of the
Prostate Care Center at
Beth Israel Deaconess Medical Center, is leading the consortium of teaching hospitals on this trial.
"By collaborating together and focusing on the patients responses over a period of time, the participating medical centers are able to be less biased and more transparent about patient outcomes," Dr. Sanda says.
For example, it is widely accepted that with robotic surgery there is less blood loss than with open surgery, and less pain at the incision site. But what is unclear are the broader areas where the outcomes are different, especially regarding sexual and urinary functioning. Additionally, the study hopes to assess if cancer outcomes are better, the same or worse following robotic or open prostatectomy.
"Once the study is complete, doctors expect to have a clearer understanding of risks and benefits of the different approaches to prostatectomy," adds Dr. Sanda.
An additional goal is for the physicians in this consortium to learn from each other. No two surgeons do operations exactly the same way, and by having large groups collect similar data, the physicians treating prostate cancer will be able to adopt nuances of surgical care that might lead to more favorable cancer outcomes.
The study also will take into account cost effectiveness of the two surgeries, including how much it cost hospitals, insurance companies and patients, and subcategories such as how much it costs patients in terms of quality of life and how long patients are out of work. For example, if a number of patients report having to be out of work for three weeks instead of four weeks depending on the surgery, that may have significant economic implications that outweigh other cost implications due to technology costs of robotics.
"The goal is a collaborative approach that evaluates, in an unbiased fashion, how much different surgical approaches cost, taking into account both equipment and post-operative patient quality of life," states
Andrew Wagner, MD, Director of
Minimally Invasive Urologic Surgery at BIDMC.
"We want to be able to give patients honest and accurate expectations. The care of a prostate cancer patient should not end with the surgery," he says. "In fact, all of my patients have my e-mail and cell phone number for post-surgery questions and follow up."
One of the interesting things about prostate cancer is that every patient is really different. Variables of cancer, individual social life, sexual activity, health and age make it a complicated disease to treat, and this study will address all of that comprehensively.
By doing in-depth and third party follow-up over a period of time post-surgery, the study can tap into real life patient experience. With prostate cancer being the most common cancer and the second most common cause of cancer deaths in American men, studies like these are critical for the future of prostate cancer care.
Above content provided by Beth Israel Deaconess Medical Center. For advice about your medical care, consult your doctor.
Posted October 2011