Medical Device Daily Executive Editor

The Agency for Healthcare Research and Quality (AHRQ) may be one of the more annoying units of the U.S. Department of Health and Human Services.

It does research – research concerning healthcare delivery and healthcare outcomes. And the annoying fact is that that the results of its research often run counter to the claims of companies making the various, and newest, medical therapies or providing the newest medical services.

Thus, the companies developing continuing permutations of devices to treat prostate cancer probably aren’t very happy this week with a new report by AHRQ saying that there is no real evidence finding one treatment obviously superior to another.

Another unforeseen result of AHRQ’s research may be to add to the confusion concerning treatment choices, though the positive in this case – perhaps – is to emphasize the need for close communication between doctor and patient and more information about where the procedure is done.

Thus, Carolyn Clancy, MD, director of AHRQ, says that the report is “a reminder that patient outcomes may vary according to treatment settings.”

The agency said that the report is the result of reviewing 592 published articles and the comparison of eight “strategies” for dealing with prostate cancer:

• complete surgical removal of the prostate and related tissue;

• minimally invasive surgery to remove the prostate;

• external radiation;

• radioactive implants;

• destruction of cancer cells through rapid freezing and thawing;

• removal of testicles or hormone therapy

• high-intensity ultrasound;

• and “watchful waiting.”

It said that there is not enough research to validate comparisons between some treatments: rapid freezing and thawing (cryotherapy); minimally invasive surgery (laparoscopic or robotic assisted radical prostatectomy); testicle removal or hormone therapy (androgen deprivation therapy); and high-intensity ultrasound or radiation therapy.

Clancy said also that the study provides “a broader message: when it comes to prostate cancer, we have much to learn about which treatments work best, and patients should be informed about the benefits and harms of treatment options.”

AHRQ’s statement concerning prostate treatments begins with a focus on surgery – saying that the outcomes for complete removal of the prostate vary according to the experience of the surgeon and the number of procedures done at a particular facility, those complications being fairly well-known and understood by most men: urinary incontinence, bowel problems and sexual dysfunction.

It goes on to say that a review of research indicates no clear advantage for surgical therapy or any other of eight treatments that it reviewed.

(In terms of complications, it said the chances of bowel problems or sexual dysfunction are similar for surgery and external radiation. And that “Leaking of urine is at least six times more likely among surgery patients than those treated by external radiation.”)

The alternatives to surgery, of course, are getting plenty of recent attention, given the perceived surge in prostate cancer – or at least a surge in its diagnosis.

AHRQ notes a doubling in the diagnosis of risk for prostate cancer from 10% to nearly 20% since the 1980s.

However, the agency points out that this increased percentage likely may be based on the more general use of the PSA (prostate specific antigen) test and that the actual risk of dying from prostate cancer has remained steady at about 3%.

The value of the PSA test, of course, was brought into question in 2004 – most prominently by its chief proponent Thomas Stamey, MD.

Stamey, who in the ‘80s had promoted the PSA a gold-standard assay for prostate cancer, at the 2004 meeting of American Urological Association, pronounced the PSA “era” was over and said the test was useless as a screening tool.

Stamey’s era-ending announcement has since been challenged by a variety of researchers emphasizing the use of PSA as a way to spot a trend pointing to higher risk and possibly cancer.

Another issue is that many prostate cancers grow so slowly that men frequently die first of other causes, raising questions about the value of early interventions in older men.

AHRQ appears to give clear underlining to these issues, saying that “considerable overdetection and overtreatment [of prostate cancer] may exist.”

AHRQ goes on to say: “The U.S. Preventive Services Task Force, a panel of outside experts convened by AHRQ that makes independent evidence-based recommendations, maintains there is insufficient evidence to recommend for or against PSA testing for routine prostate cancer screening. PSA tests can detect early-stage cancer when it is potentially most treatable but also lead to frequent false-positive results and identification of prostate cancers unlikely to cause harm.”

AHRQ says that besides not having enough evidence to say which prostate cancer therapies are best, it says this is the case “especially [among men] whose cancers were found by PSA testing.”

At the same time, it acknowledges that 90% of the men receiving prostate treatment said they would make the same choice of therapy again.

One study, according to AHRQ, showed that men who choose surgery over watchful waiting are less likely to die or have their cancer spread. The benefit appears to be limited to men under 65.

However, because few patients in this study had cancer detected through PSA tests, it is unknown if this finding would apply to those whose cancers were detected through PSA screening. Another smaller study showed no difference in survival between surgery and watchful waiting.

Among patients who choose surgery, urinary complications and incontinence are less likely if their surgeons performed more than 40 prostate removals per year.

Surgery-related deaths, urinary complications and readmissions were lower and hospital stays were shorter in hospitals that performed more prostate removals.

Adding hormone therapy prior to prostate removal does not improve survival or decrease recurrence rates, but it does increase the chance of adverse events, according to the study.

Combining radiation with hormone therapy may decrease mortality. But compared with radiation treatment alone, the combination increases the chances of impotence and abnormal breast development.

Interestingly, AHRQ says that the main goals of treatment are not to provide a cure, but “to determine whether an intervention is needed to prevent death and disability and to minimize complications.”

The report, “Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer,” is posted in the online version of the Annals of Internal Medicine.