Chapter 1.B.4--Medical Decision Making

The article belows gives a detailed example of clinical decision making in a specific case. It discusses treatment options for possible prostate cancer, detected in part by a test for prostate-specific antigen (PSA).  For those who might prefer a different example, another good article about medical decision making is James N. Weinstein, A 45-Year-Old Man with Low Back Pain and a Numb Left Foot, 280 JAMA 730 (1998).

Clinical Crossroads: A 72-Year-Old Man with Localized Prostate Cancer
Peter Albertsen
274 JAMA 69 (1995)
Reprinted with Permission

[The prostate gland is a small organ at the base of the bladder whose principal function is to produce semen. Because the prostate gland surrounds the urethra (which passes urine from the bladder), and because the prostate gland typically enlarges as m en age, older men commonly experience difficulty urinating, and surgery is common to relieve the problem. Cancer of the prostate is also common as men age. Prostate cancer is second most lethal cancer in men, and, with declines in smoking, it is likely to pass lung cancer early in the coming century. An important method for detecting prostate cancer is to measure the level in the bloodstream of "prostate specific antigen" (PSA), an enzyme that typically increases when a prostate cancer grows. This is not a very accurate test because the PSA level also rises with non-cancerous enlargement of the prostate. In addition, even if cancer is present, in the oldest men the cancer never grows large enough to cause death.]

Dr Daley: Mr S, [the patient, is] a 72-year-old retired architect ... [m]arried and the father of two grown children, [who] is writing a book on American naval history. He is insured by Medicare and carries supplemental insurance....

In 1992, Mr S went to Dr K, his primary care physician of 8 years, for a routine checkup. Dr K performed a rectal examination and noted a new slight induration of the right side of the prostate, without enlargement. A urologist confirmed the physical f indings, measured a prostate-specific antigen (PSA) level (4.3 ng/ml), and performed a needle biopsy, which revealed three areas "suspicious for adenocarcinoma, but not diagnostic." Based on these results, Mr S was followed expectantly. When the induratio n persisted 1 year later, the urologist suggested a repeat biopsy, which revealed adenocarcinoma in two of eight biopsies, one with a "minute focus" and the other with a "small focus." The areas with carcinoma were read as Gleason score 6....

In February 1994, the urologist listed the following options for the patient: (1) he could be followed for the onset of symptoms and his PSA could be monitored; (2) he could receive radiation therapy; or (3) he could undergo radical prostatectomy.

MR S - HIS UNDERSTANDING AND PERCEPTIONS

Mr S: I am currently involved in research and writing two books. My goals in life are to finish these projects, contribute to the well-being of my family, and help educate my grandchildren. I am blessed with a supportive wife to help me in making t hese decisions. Since my bypass surgery in 1981, I feel I have been living on borrowed time.

The urologist told me I have three options: surgery with complete removal of the prostate and a probable cure; a 6-week program of radiation therapy treatments that could delay the growth of the cancer, but with no guarantee of success; or to do nothin g, monitor the situation and hope that the cancer remains contained or develops slowly. With a PSA of less than 6, I have learned that although the decision is a "tough call," at my age surgery is often not recommended. I have strong feelings about surger y. Having lived with one potential life-threatening illness (my heart disease), another life-threatening illness (cancer) doesn't have the impact that it might otherwise have. I consider the removal of my prostate and the loss of sexual and possibly other functions, such as continence, a major invasion. Sexual dysfunction would be a serious consequence that I would have great difficulty accepting. I do not want to spend the rest of my life with a penile implant or some other device. Urination has always b een a necessary inconvenience; I occasionally dribble and find this annoying. Being incontinent would be something to cope with. The recovery period from surgery may be as long as 6 months, which will greatly disrupt the things I am doing.

The radiotherapist has told me about many possible, but not probable, serious side effects, the 6-week period of treatment, and a 60/40 or 50/50 chance of my becoming impotent after the radiotherapy. He said radiation probably would not make any differ ence in how long I might live, since considering my age of 72, the cancer may or may not develop before the occurrence of some other life-threatening situation. If the cancer should spread, however, I might die in 2 years. I hope I never experience a long , drawn-out, and painful death from prostate cancer, but I don't dwell on it; there are too many other things of more importance and interest on my mind. My other option is to wait and see my physicians in 6 months and reconsider my options then.

DR K - HIS UNDERSTANDING AND PERCEPTIONS

Dr K: Although Mr S is 72, he appears and acts like a younger man. His family responsibilities and his close and warm relationship with his wife, also a patient of mine, make me want to maintain a good quality of life for him as long as possible. I have tried hard to get a sense from Mr S of his priorities with respect to the quality of his life, and I have urged him and his wife to talk over all the issues together carefully. Several factors contribute to the decision: Mr S is busy writing his boo k; Mr S's cancer was picked up by chance and the prevalence at autopsy of nonlethal prostate cancer in men over age 70 is very high, so he may never become symptomatic from the tumor; the morbidity of surgery may be higher than the medical literature show s; and I find that the inflatable penile prosthesis is less satisfying to both men and women than many suggest. I also think that his biopsy results reflect a fairly benign tumor. So I have been leaning toward suggesting "watchful waiting" or possibly rad iotherapy.

It is partially happenstance that we picked up the cancer when we did. If we first made the diagnosis 2 years from now, new treatment may be available. Following his PSA levels seems sensible to me, but the urologist, radiotherapist, and oncologist say , "If you are going to do something, do it now." I am not convinced.

AT THE CROSSROADS: QUESTIONS TO DR ALBERTSEN

What would you suggest to the patient, given his stated goals, his concerns about his sexual function, the possibility of incontinence after surgery, and his quality of life? What would you say to his primary care doctor? If the patient elects watc hful waiting, what would that consist of? How would you modify your recommendations and discussion for patients of different ages and with more or less comorbid illness?

Dr Albertsen: In 1995, more than 200 000 US men will be diagnosed with prostate cancer. Like Mr S, the decisions they face regarding treatment alternatives should be based on their values and individual assessments of risks and benefits. The phy sician's role is to assemble the critical data and discuss the implications of these findings with the patient.

Mr S's diagnosis is based on the prostate biopsy.... Distant metastases are not usually seen until tumor volume increases beyond 3 cc. Since only two of the eight cores from Mr S's biopsy tested positive for adenocarcinoma and one core had a "minute fo cus" and the other a "small focus," ... Mr S's tumor volume is most likely much less than 1 cc. Two thirds of all clinical stage A and B cancers have doubling rates exceeding 4 years, so that Mr S may be in his early 80s before his tumor becomes clinicall y important....

Mr S's tumor was assigned a Gleason score of 6.... Low-grade tumors (scores 2 to 4) rarely metastasize, while tumors with Gleason scores of 7 or greater, ... frequently metastasize.... Gleason's original work estimated that men with Gleason score 6 tum ors have a cancer death rate of less than 5% per year....

Mr S's tumor is most likely confined to the prostate and will remain there for several years. This information, however, cannot predict the clinical course for an individual patient. Although the probability is low, there is no guarantee that Mr S's tu mor will not progress at some point during the next several years. If his disease spreads beyond the confines of the prostate, no known cure is available, although metastatic disease can be palliated for a while.

Since we assume Mr S has localized prostate cancer, in addition to the option of watchful waiting, he may wish to consider the following treatment options: radical prostatectomy [removal of the entire prostrate gland], external beam radiation, brachyth erapy (also known as radioactive seed implantation), cryosurgery [freezing the tumor], and immediate or delayed hormonal therapy (see Table for relative Medicare allowances and intensity of medical services for three of these options). Radical prostatecto my and external beam radiation are currently the most common treatment options, but because of advances in transrectal ultrasound imaging, there is growing enthusiasm for alternative therapies such as brachytherapy. Most clinicians would consider cryosurg ery experimental at this point, and immediate hormonal therapy is usually reserved for patients who have evidence of metastatic disease. Continued observation, sometimes referred to as watchful waiting, is always an option for any disease.

Estimated Utilization and Mean Medicare Allowances in First Year of Management of Localized Prostate Cancer*
Procedure Days in Hospital Outpatient visits Hospital Mean Allowance $ Physician Allowance, $ PSA Based on 4 Tests per Year, $
Radical prostatectomy       5 5 urologist visits 2650 (inpatient)           2250
        26
Radiotherapy     . . . 35 radiation visits
5 clinical visits
4459 (outpatient)           1630         26
Watchful waiting     . . . 2 urologist visits
2 primary care provider visits
    . . .             300         26






* Charges are Medicare allowable charges for Boston, 1994. Days in the hospital and outpatient visits are the estimated expected length of hospital stay and number of outpatient visits. PSA indicates prostate-specific antigen; ellipses, not applicable.

To make an informed decision among these treatment options, Mr S must weigh the risks and benefits of each. What is the likely outcome if he chooses watchful waiting? Although there are no randomized trials to guide us, there are several case se ries and population-based studies. Chodak et al ... found that men with moderate-grade disease face a 42% probability of disease progression and a 13% chance of dying from prostate cancer within 10 years. In a retrospective review of men aged 65 to 75 yea rs, diagnosed with localized prostate cancer during the early 1970s, my colleagues and I found that men with moderate-grade disease (Gleason 5 to 7) managed conservatively faced at most a 23% chance of dying from prostate cancer within 10 years. Mr S prob ably will survive this long: as of 1991, a man aged 72 years had an average life expectancy of 11.1 years. Mr S may live longer than this, but his cardiac disease or another illness could result in a much earlier death, regardless of his apparent good hea lth....

Based on data from case series, radical prostatectomy appears to have a high probability of rendering a patient such as Mr S disease free for more than 10 years if tumor is confined to the prostate. The only randomized controlled trial that has been co nducted comparing surgery with conservative management had insufficient power to detect a difference. The risks, however, may be significant: patient-reported complications associated with radical prostatectomy among men older than 65 years suggest that o nly 11% of men will retain potency sufficient for intercourse. Furthermore, more than 30% of men report wearing pads to deal with incontinence, and 6% have had additional surgery to treat incontinence. Surgical mortality for this procedure is less than 1% .

Mr S may consider radiation therapy via external beam or brachytherapy. The purpose of radiation is to cause prostate cancer cell death by interfering with cell reproduction. Treatment efficacy increases with higher radiation doses.... No randomized tr ials have been completed, but ... [a]mong patients such as Mr S with moderate-grade stage T2a tumors, Bagshaw et al reported 15-year cause-specific survival rates greater than 60% and actuarial survival rates of 48%....

Radiation therapy also carries risks.... Serious adverse effects occur most commonly between 6 and 30 months after treatment and usually consist of problems involving bowel ulceration and bleeding, especially involving the anterior wall of the rectum, and bladder injury resulting in urinary frequency and dysuria. Patients undergoing radiation therapy have a 40% to 66% chance of becoming impotent depending on the patient's age and the quality of his erections before treatment. Mortality from radiation t herapy is relatively rare....

Brachytherapy theoretically can deliver a much higher total radiation dose to the prostate, with less injury to adjacent organs than external beam radiation. While historically the failure rate has been high, some researchers suggest that ... [newer] t echniques may improve results. However, to date, there is no objective evidence demonstrating the advantages of one radiation technique over another.

Mr S could explore the possibility of cryosurgery, which uses ultrasound-guided placement of cryoprobes to destroy malignant cells within the prostate by freezing them. However, Mr S should recognize that this is an experimental approach and that no lo ng-term data concerning treatment efficacy or treatment complications have been published....

How should Mr S synthesize this information? ... I would encourage Mr S to discuss the treatment alternatives with his wife and other potential counselors such as his family physician or his clergy. If he is considering surgery or radiation, he should speak to both a urologist and a radiation therapist. Finally, he may want to contact a patient support group to discuss his situation with other men who have faced a similar decision. Mr S has the time to make an informed decision, but it is a decision th at only he can make.

QUESTIONS AND DISCUSSION ...

An Internist: Let me raise another option: in clinical areas where no consensus exists, patients can volunteer to enroll in clinical trials. The National Cancer Institute, the Department of Veterans Affairs, and the Agency for Health Care Policy an d Research are mounting a collaborative randomized trial of prostate cancer intervention vs observation that will enroll about 2000 men over several years and follow them for up to 15 years.... Obviously, it will take 10 to 15 years to get answers.

Dr Albertsen: The diagnostic and treatment cascade begins with using PSA to screen for prostatic cancer; ... [a] PSA level greater than 4 ng/mL often sets in motion a series of decisions and actions that consume lots of health care resources. Fo r a 62-year-old man who faces a significant risk of dying from his disease, this may be appropriate. The patients who are diagnosed in Hartford, Conn, where I work, however, have an average age of 70 years.... The older the age of the patients you screen, the more you ask questions that lack answers and pose difficult problems for patients. At some point, I'm not sure you're doing the patient a service any longer. Internists and primary care physicians should question why they are ordering initial PSAs in men aged 75 and older, especially among those men who have normal rectal examinations.... You're opening Pandora's box.

Dr K: Have you ever tried to talk a patient out of antibiotics for a cold? We have patients who come into our office waving magazine articles and The New York Times ads saying, "Where's my PSA, doc?" We take a lot more time convincing them that they shouldn't have it measured than ordering it, and that's one of the real issues we face in the office....

A Urologist: Urologists often raise the question of being put in an awkward position by primary care physicians who do a PSA test in patients who may have indicated they are not candidates for aggressive therapy. What the primary care physicians often raise is the medicolegal specter in the area of not screening or testing. But there's an interesting catch-22 - the medicolegal standard of care becomes what physicians do. If primary care physicians all do PSA testing for fear of being sued if the y don't, then eventually if enough of them do it, they'll create the truth of their fear. If we think through, with each patient, what the pros and cons of testing an individual are and document that information - even though it is very time-consuming and that's a problem - we may not back ourselves into the corner of having to do it because everyone else is doing it.

A Surgeon: I enjoyed Dr Albertsen's comments, but I take issue with one point at the end of his discussion - that the decision should be left to the patient. While I regard the decision of the patient as obviously being key, it seems to me that the doctor has the responsibility to tell the patient what he or she thinks is best. I think the patient really wants to know what you - the doctor - think about what should be done with this problem. I think that you should always answer that in the best way that you can.

Mr S: I don't think that I wanted my doctor to make the decision for me, but I did want his honest opinion. I remember asking him, "What would you do if you were in my position?" He did not tell me . . . .

An Internist: Clearly, who you see and where you see him will have a dramatic effect. Even in 1989, before PSA was widely used, rates of radical prostatectomy were variable: in Connecticut, where Dr Albertsen practices, the probability that a ma n turning 65 would get a radical prostatectomy during the next 10 years was less than 1%; in Seattle, it was close to 5%. Medical communities apparently feel differently about the procedure....

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Editors' questions: What would you do if you were the patient? The doctor? Are the pressures to do something of little benefit or probable harm so great that we would be better off without the diagnostic information provided by the PSA, in other words, should that test simply not be done + for patients over 70? Should the entire range of options presented here be fully insured, or should the patient have to shoulder some or all of the costs of pursuing some options over others?

Studying the difficulty that patients have in making these decisions and understanding their options rationally, see Thomas D. Denberg, Trisha V. Melhado, & John F. Steiner, Patient Treatment Preferences in Localized Prostate Carcinoma: The Influence of Emotion, Misconception, and Anacdote, __ Cancer ___ (2006). These authors found that "patient treatment preferences were not based on careful assessments of numerical risks for various clinical outcomes. Instead, feelings of fear and uncertainty contributed to a desire for rapid treatment, and specific preferences were profoundly influenced by misconceptions . . . and by anecdotes about the experiences of others with cancer."