Patient Involvement Key to Better Prostate Care

Press Release Date: August 22, 1995

A five-year study of prostate disease treatment supported by the Agency for Health Care Policy and Research concluded today that men with localized prostate cancer or nonmalignant enlargement of the prostate gland—benign prostatic hyperplasia or BPH—should take a more active role in choosing their own treatment strategy.

The final report of the study, released today, says giving patients a greater role in treatment decisions could lower the number of prostate surgeries without sacrificing outcomes, and might help reduce Medicare costs.

The Prostate Disease Patient Outcomes Research Team, or PORT, is the first of AHCPR's PORTs to be completed. The study, which was led by Dartmouth Medical School's John E. Wennberg, M.D., and involved researchers and patients in several geographic areas, examined the outcomes of both surgical and nonsurgical management of localized prostate cancer and benign enlargement of the prostate.

AHCPR Administrator Clifton R. Gaus, Sc.D., said, "The prostate disease PORT led the way in reshaping thinking about what's best for the patient." Dr. Gaus said the study addressed clinical and patient-oriented questions that were previously overlooked or ignored.

Dr. Wennberg said the prostate disease PORT challenged the conventional wisdom that mild symptoms of BPH always will get worse. The PORT also contradicted the common misconception that without treatment, prostate cancer will inevitably become life- threatening.

Prostate diseases are among the most prevalent health problems paid for by the Medicare program. BPH affects more than half of all men over age 60 and about 8 of every 10 men by age 80. Prostate cancer is present in 20 percent of all men over 65 years of age and in about half of those reaching age 85.

Prostate diseases also are costly. For example, transurethral resection of the prostate (TURP)—the most common surgical procedure for relieving BPH symptoms—is performed more than 300,000 times a year at an annual cost of over $2 billion. The frequency of the operation rose dramatically in the 1980s, but since 1991 has declined. Use of radical prostate surgery to remove the prostate gland in men with localized prostate cancer increased by more than 500 percent among men 65 and older between 1985 and 1990, but despite this, the death rate for prostate cancer remained the same.

Benign Prostatic Hyperplasia

Key recommendations of the AHCPR study were that watchful waiting be made the standard strategy for men with mild symptoms of BPH and that management of the problem be based on the degree to which a man is bothered by his symptoms, rather than on urine flow rates and other laboratory measures. The researchers found there is little scientific information on how the disorder progresses and that untreated men often do well for years. They also found that differences in physicians' practice styles have contributed to wide geographic variations in BPH surgery rates.

These and other findings were used to develop the BPH Shared Decisionmaking Program, an interactive, computer-assisted videodisc program for helping patients choose between watchful waiting, drug therapy or surgery based on information provided by the program on the risks and benefits of each treatment option. The program has been installed in a number of urologic practices in the United States and Canada, and its impact on patients' treatment decisions has been tested with hundreds of men.

Patients who use the videodisc program tend to be more conservative in their treatment choices—that is, to select surgery less often.

The PORT researchers also participated in the development of the AHCPR-sponsored clinical practice guideline for diagnosing and managing BPH (released February 1994), which was partly based on findings from the study.

In addition, the investigators were instrumental in developing and validating the American Urological Association BPH symptom index, which is now in wide use in everyday practice in the United States and is being used in clinical trials of BPH treatment methods. The index, which measures the severity of symptoms and the degree to which they bother patients, has been adopted by the Second International Consultation on BPH in conjunction with the World Health Organization.

Localized Prostate Cancer

AHCPR's prostate disease PORT found that the scientific literature provides no hard evidence that radical prostate surgery or radiation therapy help older men with localized prostate cancer survive longer, compared with watchful waiting. The operation may benefit some younger patients with higher-grade tumors.

Despite the lack of evidence of radical prostate surgery's effectiveness for treating localized prostate cancer in older men, half of all men who underwent the procedure under Medicare between 1985 and 1990 were 70 years of age or older.

The study was the first to report a substantially higher complication rate from radical prostate surgery than had been reported previously in case studies. In the PORT's nationwide survey of Medicare patients who had radical prostatectomies, nearly one-third of all respondents said they still had to wear absorbent pads for incontinence two to four years after surgery, and up to 89 percent reported they were impotent.

According to the researchers, watchful waiting is a reasonable alternative to invasive treatment for many older men with localized prostate cancer.

Prostate-Specific Antigen (PSA) Test

The investigators concluded that there is not enough evidence to support the recommendation that all men over 50 years of age be regularly screened for prostate cancer with the PSA blood test, and they questioned the routine use of the test on men with BPH symptoms, since no evidence exists that the disorder is associated with an increased risk of prostate cancer.

PORT II Research

AHCPR's PORT II for Prostatic Diseases, awarded in September 1994, builds on the original PORT research. The new project will continue to investigate the effectiveness and cost of PSA screening, and the effectiveness of aggressive treatment for prostate cancer with radiation and radical prostatectomy. The PORT-II also will investigate the current patterns of screening, diagnosis and treatment of prostate disease in relation to outcomes in primary care settings.

Other Contributions of AHCPR's Prostate Disease PORT

The original PORT study served as a catalyst and resource for other efforts to improve prostate care. These activities include:

The Prostate Cancer Intervention Versus Observation Trial—a randomized clinical trial funded by the Department of Veterans Affairs, the National Cancer Institute, and AHCPR.

A three-year randomized trial of different strategies of drug treatment for BPH—Prostate PORT researchers participated in the planning and execution of the trial which is being conducted by the Department of Veterans Affairs Cooperative Studies Program.

Interactive videodiscs—The Foundation for Informed Medical Decisionmaking, which was founded by Prostate PORT researchers, has produced videodisc programs to educate patients about BPH, prostate cancer and the PSA test.

Randomized Trial of the Shared Decisionmaking Program for Patients with BPH—an AHCPR-funded study to evaluate the effectiveness of the Foundation's interactive videodisc for educating men about BPH and treatments.

AUA prostate cancer guideline—Prostate PORT researchers participated in the development of this practice guideline on localized prostate cancer treatment by the American Urological Association.

During the course of their study, the Prostate PORT researchers published 60 articles in professional journals and made over 97 presentations to professional groups, including the American Urological Association, American Academy of Family Physicians and The American College of Physicians. At last count, more than 680 published newspaper and magazine articles have cited the study's findings.

An overview of the research is provided in PORT Findings: Prostate Diseases (publication number 95-0086), which is available from AHCPR by calling 800-358-9295. Prostate Disease: Patient Outcomes Research Team Final Report is available from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (publication number PB95-253811; $19.50 paper, $9.00 microfiche). Call (703) 487-4650 to order.

For additional information, contact AHCPR Public Affairs: Karen Migdail, (301) 427-1855.