Comparative data on the various options for treatment of early stage (localized) prostate cancer

The “New” Prostate Cancer InfoLink Prostate believes that, as of early 2008, there are now two things that we can state with a reasonable degree of scientific certainty with respect to the comparative value of different types of management for early stage prostate cancer, and those are the following:

  • There is preliminary evidence to suggest that radical surgery is a better treatment option than watchful waiting for younger men (i.e., men aged 65 years and younger) who have a reasonable life expectancy of 10-15 years, strong evidence of localized disease, and no contraindications to surgery.
  • There is also good preliminary evidence to support the belief that open radical retropubic prostatectomy and laparoscopic radical prostatectomy, in the hands of surgeons with a comparable degree of experience with these techniques, both produce good outcomes in the short term (median follow-up 18 months), with distinctions that are attributable to the techniques or perhaps to the surgeons themselves. (Long-term follow-up data are not yet available.)

What Do We Actually Know?

There has only ever been one, large, prospective, randomized clinical trial completed to date that compared one form of management to another for patients with localized disease. This trial compared watchful waiting to open radical prostatectomy in Scandinavian men believed to have localized disease (stages T1-T2N0M0). The trial involved 695 men with localized prostate cancer, enrolled between 1989 and 1999, and the results of this trial were last updated in 2008. The details of this trial are provided on another page.

There is also one large, prospective, single institution trial involving 1,430 consecutive patients who elected to receive either open radical retropubic prostatectomy (RRP) or laparoscopic radical prostatectomy (LRP). The surgeons who carried out the 1,430 procedures are widely regarded as being among the most skilled and knowlegeable in their techniques. Again, the details are available on another page.

There has only ever been one, small trial that compared radical surgery to radiation therapy for treatment of localized disease. This trial was conducted by Paulson et al. and the results were published in 1982. These results have always been a subject of controversy between the surgical and the radiation oncology communities. The simplest way to look at this trial now is to say that the patients enrolled in that trial are no longer representative of patients diagnosed with localized prostate cancer today, and that therefore its results are only of historic relevance.

In other words, from a comparative point of view, based on actual scientific data, we really know very little indeed.

What Is Being Tested Today?

There are three major, ongoing clinical trials, all of which are designed to test the comparative value of surgery or radiation therapy to watchful waiting:

  • A large, prospective, randomized, multicenter clinical trial comparing watchful waiting to radical surgery for treatment of prostate cancer is fully enrolled and currently ongoing in the USA. This trial is known as the PIVOT trial (the Prostate Cancer Versus Intervention Trial). It has enrolled 1,050 men, and the earliest results of this trial are expected in November 2009.
  • A second large, prospective, multicenter clinical trial is being carried out in the UK. The trial is interesting because patients may opt for a specific arm of the trial or be randomized to either arm. This trial was initiated in 2001 and is still enrolling patients. Again, its primary goal is to compare watchful waiting to radical surgery, although additional radiotherapy is an option for patients with PSA progression post surgery. The trial will include 2,050 patients and will not report results before about 2015 at the very earliest.
  • A third large, prospective, multicenter clinical trial was initiated in Canada and the USA in 2006. This is the most expansive trial yet because it includes the possibility of four different types of management: watchful waiting, radical surgery, brachytherapy, and external beam radiation therapy. Patients are being assigned to either watchful waiting followed by intervention as needed or to immediate intervention based on physican and patient selection. The trial will include 2,130 patients and the earliest results aren’t expected before 2023. It is important to understand that this trial will not compare the outcomes of the different interventions possible. It will only compare watchful waiting to any of the possible interventions.

In addition, there are ongoing trials comparing some of the less common forms of treatment:

  • There is a randomized, single-center clinical trial of external beam radiotherapy vs. cryotherapy as first line treatment being conducted at the University of Calgary in Canada. Whether this trial will be big enough to give us meaningful data regarding the relative merits of these two treatment options in a well-defined patient population may be open to some question.
  • There is also a randomized clinical trial of high-intensity focused ultrasound (HIFU) vs cryotherapy being conducted in men who have failed first-line radiation therapy. This is a pivotal trial that may (or may not) lead to approval for the use of HIFU in the USA.

What Will We Never Know

It seems highly unlikely to The “New” Prostate Cancer InfoLink that we will ever see any of the following trials carried out:

  • A large randomized trial of any form of surgery vs. external beam radiotherapy
  • A large randomized trial of any form of surgery vs. brachytherapy
  • A large randomized trial of brachytherapy vs. external beam radiation therapy

This may, in fact, be a good thing, because by the time we got the results, the forms of treatment being used would have evolved in such ways as to make the results relatively meaningless.

What Might We Get to Know?

There are certain trials that The “New” Prostate Cancer InfoLink thinks could get implemented in the future, but probably not in the next decade. They include the following:

  • A large randomized trial of laparoscopic radical prostatectomy vs. high intensity focused ultrasound (HIFU)
  • A large randomized trial of brachytherapy vs. HIFU
  • A large randomized trial of external beam radiotherapy vs. HIFU

We aren’t too confident about any of these trials, but the possibility is certainly reasonable, and with second- and third-generation HIFU technology coming more broadly available it may become imperative for these trials to take place.

Content on this page last reviewed and updated August 13, 2008.

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