RALP vs. ORP: data from a randomized Phase III clinical trial

A newly published paper in The Lancet has provided us with data from a randomized, Phase III, clinical trial of open radical retropubic prostatecomy (ORP) vs. robot-assisted laparoscopic prostatectomy (RALP) in the surgical treatment of localized prostate cancer.

This trial was conducted at a single institution (the Brisbane and Women’s Hospital) in Brisbane, Queensland, Australia, between August 23, 2010, and November 25, 2014. The initial outcomes data have been published by Yaxley et al. and are also discussed in detail in a commentary on the MedPage Today web site.

The trial enrolled exclusively men who had been newly diagnosed with clinically localized prostate cancer and who had elected surgery as their treatment approach. The patients also had to meet the following other eligibility criteria:

  • The ability to read and speak English
  • No prior history of head injury, dementia, or psychiatric illness
  • No other concurrent cancer
  • An estimated life expectancy of 10 years or longer
  • Age between 35 and 70 years

All patients were randomly assigned to treatment by ORP or by RALP. However, this was an “open” trial. The clinical study investigators and the patients all knew who had received what type of treatment, but the investigators participating in data analysis did not know anything about each patient’s condition. In addition, the central pathologist who reviewed the biopsy and radical prostatectomy specimens was also not aware of the patients’ conditions or outcomes.

All the ORPs were carried out by a single surgeon who had completed about 1,500 ORPs prior to initiation of the trial; all the RALPs were carried out be a single, different surgeon who had completed about 200 RALPs prior to initiation of the trial.

Here is a summary of the core data from the trial:

  • A total of 326 patients were initially enrolled into the trial and randomized to treatment, but 18 withdrew prior to treatment; thus
    • 151 patients were randomized and actually received an ORP.
    • 157 patients were randomized and actually received a RALP.
  • 121/151 patients (80.1 percent) assigned to ORP completed the 12-week post-surgical questionnaire.
  • 131/157 patients (83.4 percent) assigned to RALP completed the 12-week post-surgical questionnaire.
  • With respect to intraoperative adverse effects,
    • 12/151 patients (8 percent) in the ORP group experienced such events.
    • 3/157 patients (2 percent) in the RALP group experienced such adverse events.
  • EPIC urinary function scores were not significantly different between the groups.
    • 74.50 for the ORP group and 71.10 for the RALP group at 6 weeks post-surgery (p = 0.09)
    • 83.80 for the ORP group and 82.50 for the RALP group at 12 weeks post-surgery (p = 0·48).
  • EPIC/IIEF sexual function scores also did not differ significantly between the groups.
    • 30.70 for the ORP group and 32.70 for the RALP group at 6 weeks post-surgery (p = 0.45)
    • 35.00 for the ORP group and 38.90 for the RALP group at 12 weeks post surgery (p = 0·18).
  •  With respect to risk for positive surgical margins (PSMs)
    • 15/151 patients (10 percent) in the ORP group exhibited PSMs on post-surgical pathology.
    • 23/157 patients (15 percent) in the RALP group exhibited PSMs on post-sugical pathology.
    • This difference was also not statistically significant (p = 0.21).
  • With respect to post-surgical complications
    • 14/151 patients (9 percent) in the ORP group exhibited such complications.
    • 6/157 patients (4 percent) in the RALP group exhibited such complications.
    • This difference  showed a trend toward statistical significance (p=0·052).

The only really significant difference between the open and the laparoscopic procedures reprted in this paper was estimated average total blood loss during the course of the operation (1,338.14 ml for ORPs vs. 443.74 ml for the RALPs; i.e., three times higher for the ORPs).

The authors’ interpretation of the data from this trial is as follows:

These two techniques yield similar functional outcomes at 12 weeks. Longer term follow-up is needed. In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than a specific surgical approach.

This interpretation is in line with what many have been saying for years, which is that the skill and experience of the surgeon and his or her support team in the use of a specific type of technique (open retropubic, open transperineal, laparoscopic, robot-assisted laparoscopic radical prostatectomies) is probably far more significant than which of the techniques is being used per se.

The other thing that the authors don’t comment on is this: since the vast majority of urologic surgeons in training around the world are now learning to conduct radical prostatectomies using robot-assisted forms of laparoscopic technology, there can be little doubt that over the next 10 to 15 years there will be fewer and fewer trained and experienced surgeons who know how to carry out an operation like this really well without the access to this type of technology.

4 Responses

  1. Thank you for posting a review of this and other articles. We are so privileged to have access to this prostate cancer portal. Spending time reading thru the posts should be required reading for patients and family needing to have evaluation and treatment for prostate cancer.

    In this article, it is interesting to see that the robot-assisted radical prostatectomy (RALP) did so well with the surgeon having what one might say is the minimum (200) RALPs under his belt.

    The rate of positive margins has always been a concern for me if a radical prostatectomy were needed (10 to 15%). Here you are going to have major surgery and you might not be cured. It would be nice if a way to improve on this could be found without increasing other complications, i.e., sexual and urinary side effects.

    Mention is made about the fact that there is going to be a dwindling supply of urologists who can perform an open radical prostatectomy because everyone in training is getting experience with RALP. This is quite true, and presents another problem — and that is that one of the problems with RALP is equipment failure and abandonment of the RALP procedure and finishing it with an open procedure. This comes from a report from Seattle in which they cited equipment failure with RALP occurring in 3 to 5% of cases.

    Equipment failure might seem like a remote issue. It may not be. A family member was scheduled to have a relatively minor non-prostate cancer but prostate-related cancer surgery and the surgeon made a big point of saying he was going to use a special laser for the procedure. I was in the waiting room watching the clock and time dragged on longer than expected. It turned out they could not get the laser to work even with the laser company technician present. Fortunately, the surgeon was older and very experienced and could complete the surgery with his scalpel.

    One previous person on this site commented that he picked a surgeon with both open and RALP experience rather than one with just RALP experience. I don’t know how things turned out for him and hopefully well. One of the things I added to my list of questions if I ever needed a RALP is — what is your plan if there is a problem with the robot, i.e., can you do an open radical prostatectomy or will there be someone on call who can if needed?

    There has been published literature on how many RALPs it takes to develop competency. One study said it took 200 RALPs, in spite of numerous comments from people online that they preferred someone who has done at least 1,000 RALPs. An article appeared a year or so ago on how one could look up one’s urologist and see his/her Medicare surgical complication rate by procedure. I did not see my younger urologist and asked him why his name was not listed. His reply was that he had not done enough RALPs to make the database and that even 200 RALP was a lot of radical prostatectomies. He also said, “What are you going to do when those who have done 200+ RALPs retire?” Hopefully, I will not need a radical prostatectomy!

    Thank you again for making possible this exchange of information.

  2. Dear Walter:

    The problem of equipment failure (in every industry) is hardly limited to robot-assisted surgical equipment. The more complex the equipment we develop and choose to use, the greater the possibility that something can and will go wrong. The old oven your grandmother used to cook on and in almost never went wrong. There was almost nothing that could go wrong! Today we have ovens that something breaks in every 3 to 5 years. Having said that, equipment failure with the da Vinci surgical robots does seem to have declined significantly over the past 10 years.

    With respect to the number of surgeries one needs to do to become a competent and skilled prostate cancer surgeon (whether it is using open or robot-assisted techniques), the general consensus is that it is about 200 procedures. However, the very best surgeons will always tell you that they are still learning after thousands of procedures, and there was one study out of Memorial Sloan-Kettering Cancer Center some years ago that showed that the very best results — in a study encompassing all of their surgeons who had done more that 10 procedures — were from a surgical resident who had done just 50 operations. You need to remember that some people are just naturally highly talented at manipulative procedures like surgery and some others will reach a plateau beyond which they just don’t get much better because they don’t have the natural skill level to keep improving very much. Surgeons are just human beings like the rest of us. Some are better and more talented surgeons than others.

  3. Sitemaster, thank you for your reply. That is a good point that numbers of surgeries do not tell the whole story.

    I do not envy anyone trying to find the best surgeon for their RP. It is not easy.

    In preparation for a possible RP (which it turned out I did not need), I later found out the surgeon I had tentatively picked had PSMs of 10 to 15%, which did not sound so great to me, as I would want to be cured if I had to have surgery for stage I or II prostate cancer. Also, the surgeon did not accept Medicare which meant a pre-surgery deposit of several thousand dollars, which could be an issue for some.

    My own younger personal urologist let his hair down one day and lamented that Medicare, probably in an effort to cut down on RPs, only paid the surgeon $850 for a RARP which he thought was extremely low. On the subject of post-op impotence complication from RARP, he thought it was a hit or miss proposition. He said in cases where he really made an effort to minimize the possibility of post-op impotence, he was often unsuccessful, and in other cases, where he had been more aggressive and thought for sure the person would be impotent, they turned out fine. In the end, he thought the impotence issue could be fixed by medications and/or impotence surgery and he was not overly concerned about that particular complication.

    Thank you again for all the help you are providing people by your literature reviews. Your site link deserves to be on every website that deals with prostate cancer.

  4. Walter:

    With regard to what it can cost to have a radical prostatectomy (or almost any type of treatment), it is all over the shop, even por Medicare coverage, which varies by region. And of course when the surgeon decides not to accept Medicare, the vast mahjority of patients just don’t have a spare several thousand dollars.

    With respect to impotence, I think it’s rather more complex than “hit or miss”, but there is certainly a “hit or miss” element because so much depends on the anatomy of the individual patient, which can vary enormously from patient to patient.

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