September 25, 2000

PROSTATE CANCER TREATMENT:
TOO MANY RADICALS - TOO MANY FAILURES!

According to recent reports, 1997 represented a record number of radical prostatectomies for prostate cancer. That statement likely represents a dichotomy of thought. Ideally, this statement suggests that urologists are diagnosing prostate cancer at an earlier age. Hopefully this should impact survival from a potentially devastating disease that claims the lives of more than 30,000 men/year. The enthusiasm generated from our record year quickly becomes muted when you realize that the vast numbers of these patients are only being offered radical prostatectomy. This would suggest that radical prostatectomy effectively works for all patients. Obviously, we know that is not correct. If it were, there would be no need for radiation therapy or cryosurgery and our success rate to cure would be exceptional. Depending on whom you talk to, successful therapy from radical prostatectomy varies nationally from 60% - 90%. Many physicians continue to claim success even in the face of a rising PSA (prostate specific antigen), post-operatively. A rising PSA following definitive therapy translates into the failure to properly select a disease for a procedure. Many of the record harvest from 1997 may have done far better with intermittent hormonal therapy, improved diet, exercise, and a dedicated, knowledgeable physician coach. This methodology or Chronic Disease Management (CDM) spares the obvious potential or likelihood for incontinence, impotency, surgical wounds, emotional stress and significant chance for the return of the dreaded disease.

In the not too distant past, Arnold Palmer, (world-class Golf Professional), was diagnosed with prostate cancer. While I do not know the specifics of his disease, I do know that it was organ confined as Mr. Palmer underwent a radical prostatectomy at The Mayo Clinic in Rochester, Minnesota. This case demonstrates that our abilities to make proper judgement of who will be the best candidate for any treatment course are seriously flawed. In Mr. Palmer's case, the reality and sadness came when it was revealed that he would require follow up radiation. In plain and simple terms, radiation suggests that the initial therapy selected was inappropriate and ineffective. While I personally wish Arnold Palmer well, this case points to the dogma or arrogance relating to the patient-physician, disease decision process. Physicians tend to be the judge and jury for what is best for the patient. This is difficult to swallow unless the physician is well versed in all modalities of treatment including intermittent hormonal manipulation. Rhetorically speaking, if we cannot get it right at a premier institution of urologic excellence and care, attended by arguably the world's most brilliant minds and surgeons; what then can we expect from other venues of prostate disease treatment around the country? Maybe it is time to rethink how we handle prostate cancer!

At the Prostatitis and Prostate Cancer Center, I see patients from all over the country. While these patients are seeking a second opinion, the vast majority of these patients have not been properly schooled as to the risks and benefits of all treatment options. A common finding is that patients state that their doctors have told them that cryotherapy is still experimental. The American Urologic Association approved cryosurgery in 1997 as an appropriate, acceptable treatment modality.

It is my expressed opinion that most men are being pressured, intimidated, or even frightened into making what ultimately turns out to be the wrong choice or unnecessary misstep. While we can all make mistakes, what's wrong with choosing the most conservative option first, where no bridges are burned and minimal side effects are noted. A model for therapy would put all patients on hormonal manipulation at the time of diagnosis, improve and implement our educational tools professionally, and more importantly give the patient reasonable time to put thought to what ultimately will be the most important decision in their respective lives. It may well be that intermittent therapy is the best choice.

Most patients who come to our clinic are trying to avoid radical prostatectomy at all costs. As a surgeon, I must say, there are times when the best choice for a patient may be a radical prostatectomy. I'm in the patient's corner, however, and recognize that I must first do no harm! The least amount of harm is done with the most conservative approach that leads to success with minimal morbidity. At the clinic, we carefully evaluate every patient in a standard 1 or 2 day comprehensive visit. Before we can formulate a plan we must first have all of the facts. Patients typically spend 3 or more hours in diagnostic testing and intense consultation. Patients are encouraged to send their records ahead of time to allow ample pre-visit analysis performed at no charge to the patient. Every patient is treated as an individual guided by the patients' goals and/or objectives. Most patients who see us have made the conscious decision to seek our objective opinion and avoid the status quo treatment approach. Clearly, we opt for the most conservative approach to remedy the problem with the least amount of physical and emotional scarring. Chronic disease management (CDM) allows patients to maintain a quality of life not usually seen with other formal prostate cancer treatment modalities. While most physicians are well intentioned, the truth remains that we are unable, by and large, to predict which patients will benefit best from any particular form of therapy. The successful treatment of prostate cancer, therefore, remains somewhat of an academic crapshoot.

In a recent survey published in JAMA (2000; 283: 3217-22), more than 500 urologists were asked the question, per my recollection, what to do with a 65 y/o male with organ confined prostate cancer with a Gleason score of 7. This patient profile for disease discussion is common. Not surprisingly, party line opinion is evident, as 90% of the urologists polled would recommend a radical prostatectomy for this patient. In an effort to provide freedom of professional expression and prove that all professionals are biased, more than 500 radiation oncologists were asked the same question. Again party line is served as the majority supported external beam and/or seed therapy. What is wrong with this picture? Why can't the majority in either group of professionals recommend intermittent hormonal therapy as the best initial treatment course? If radiation therapy, cryosurgery, or even radical prostatectomy is ultimately decided upon, what has been lost? Why the rush to judgement? What's the hurry? As professionals, we certainly must have learned something from the travails of our patients. Surely if we were asked, what we would want for ourselves if we were that 65 y/o, most of us would run and hide thinking it had to be a bad dream. Collectively, none of us wants a dose of our own medicine if it leads to a path of destruction or uncertainty.

Patients who come to the Prostatitis and Prostate Cancer Center are seen with all stages and phases of disease and disease treatment. Dissatisfaction and lack of direction or lack of a definitive plan is the most common complaint. The second most common complaint is that "my doctor doesn't know what else to do". Most patients who come to our center choose an antiandrogen approach while they continue to sift through volumes of educational material. This may or may not represent the end point to treatment as the progress made and questions asked and answered will dictate the next move. In fact, the best approach to prostate cancer is to apply the analogy of a chess match where every move is critical to the final outcome. Our goal at the center is to present a balanced opinion of all options and to coach the patient in any area applicable. A rush to judgement is definitely not a part of our repertoire.

Additionally, we expect to intermittently implement a period of anti-androgen therapy or combination hormonal therapy, thereby, maximizing quality of life issues like maintenance of sexual performance and bladder control; not to mention emotional stability. Clearly, our program is compassionate to the patient and his family. When it comes to prostate cancer treatment, "ONE SIZE DOES NOT FIT ALL", therefore, the only plausible strategy that makes sense to all patients is anti-androgen therapy with or without central acting hormone manipulation. We need to continue to search for improved patient friendly approaches that do the job intended. As physicians, we must be self-critical of our individual performance, realizing that the standard set by the past may not be applicable for the future. The satisfaction and acceptance of less than appropriate outcomes breeds complacency. In this situation, where's the impetus to challenge the status quo, change your attitude, or change your approach? I submit to you that complacency leads to failure and obsolescence. Such may be the case with our overwhelming enthusiasm for radical prostatectomy as the best answer for disease cure. I further submit to you that the only methodology that predictably protects a man's sexuality, does not burn a bridge or preclude a change in treatment direction, and avoids the indignity of incontinence is intermittent hormonal therapy.

I have had the pleasure of taking care of a former attorney general from a neighboring state to Colorado. This patient was diagnosed with prostate cancer in 1991. At the time of his diagnosis his PSA was 44 ng/ml. His Gleason score was 7 with an aneuploid flow cytometry. After careful discussion of radical prostatectomy and radiation therapy, the patient decidedly stated that he would not tolerate the risk of impotency and/or incontinence. He also could not go along with a procedure of unpredictable benefit. He asked if I had some other option that could be tried. I had explained carefully that I had other methodology that I thought made sense but that the long term benefit data had not been gathered and in fact had not been part of any prospective study.

It was clear to me that this proud and accomplished gentleman would not tolerate the indignity, pity, and shame that traditional prostate cancer treatment brings. It was also clear that without my professional guidance and my willingness to learn from his experience, I would lose a patient and a friend. I had realized that his cancer would consume him if I did nothing.
Notwithstanding my traditional surgical training in prostate cancer disease management, I was willing to look beyond the four walls of urologic dictum. I was asked to use my God given abilities to reason and judge rather than to just react and offer the party line of treatment.

This man, who had been on a variety of anti-androgen therapies intermittently over the years, represented the penultimate challenge to me as a person and as a professional. While there is risk of failure and the threat of overwhelming collegial criticism, my willingness to serve as a coach or consultant to this patient brought hope for another day. This patient and I shared accountability and responsibility to his ultimate success. Today, almost 10 years later, this patient at 82 y/o has a PSA of 1, maintains his sexuality and effusively states that he owes his extended life to me. While I am pleased that all has worked to this point, it was a strategy that made sense. I, steadfastly, refuse to become less vigilant as I doggedly monitor this patient's prostate health markers on a regular basis.

The attorney case typifies a growing segment of men, who seek the most conservative yet effective treatment for prostate cancer. These patients refuse to accept that the only management of prostate cancer is to compromise their sexuality, bladder control, and state of mind for a chance at a prostate cancer cure. William Fair, M.D., Urologist and former chairman of the Department of Urology at Memorial Sloan Kettering, recently stated that we should look at treating prostate cancer as a chronic disease. You will not get an argument from the Prostatitis and Prostate Cancer Center or the former state attorney general. I believe that the pendulum is starting to swing to the patient's advantage. Through the Internet, people are becoming more knowledgeable and less tolerant to our collective dogma and party line traditional treatments. Knowledge brings empowerment, opportunity, and hope for a better way. In an upwardly mobile society, there is little reason that patients cannot come to our clinic in Sarasota or visit any other expert of their choosing. As someone said, "life is short and then you die". Life is indeed short, such that we owe it to ourselves and our families to avoid untimely health decisions or death from prostate cancer. Collectively, we must seize the moment to educate on issues of prostate health and disease and prepare to be a partner in all decisions relating to prostate health. Ignorance can no longer be tolerated when your life is at stake. The health team that you assemble will dictate your life's course.

Our conservative clinical posture focuses on all aspects of men's health. In an ongoing study from which I presented data at the NIH Prostatitis Collaborative (November, 1999), I have shown that the vast majority of voiding symptoms (frequency, urgency, slow stream, etc.), experienced by men, as we age, are reflective of prostatitis and not BPH, (benign prostatic hyperplasia or enlargement). This data may be reviewed on the Internet at www.theprostatecenter.com. It is estimated that 45 - 50% of men in their fifties experience bothersome voiding symptoms of some degree. Fiscal data shows that 2 billion dollars was spent in 1994 on surgical intervention for voiding symptoms. While some men truly have BPH and may benefit from surgery, we reserve this indignity as a last resort. At the Prostatitis and Prostate Cancer Center, all men are evaluated for prostatitis as part of the routine diagnostic work-up.

Prostatitis is diagnosed by a review of the expressed prostatic secretion, (EPS), obtained at the time of digital rectal exam, (DRE). If prostatitis is discovered, men are offered an opportunity to participate in an open label study that randomizes patients to one of three antibiotics versus an all-natural complementary formula. Unfortunately, we are having trouble with patient accrual as patients recognize the limitations of antibiotics to cure prostatitis. Additionally, men like the idea of taking something all natural with a track record of success.

A case that validates this approach involves a 58 y/o male from Largo, Florida who was seen at the Sarasota clinic. This gentleman had an American Urologic Association, (AUA), symptom score of 18-19, (high moderate symptoms with obstructive and irritative components). Cystoscopy performed by a competent Florida urologist showed blockage of the prostate supportive of the surgery that he had scheduled. In an effort to avoid surgery, this patient paid a visit to "the coach". After a thorough review, it was determined that the patient had prostatitis, confirmed by the EPS. In accordance with our data, this patient had an 88% chance of prostatitis based on voiding symptoms alone. This was confirmed with the physical exam. Given a full discussion of all options, this patient opted for our all-natural prostate formula. Antibiotics given previously by the Largo urologist had no demonstrable effect. In a little more than 1 week on this formula, this patient's AUA symptom score dropped to 1-2, (consistent with mild symptoms).

Needless to say, this man avoided prostate surgery and continues to do well at 3 months. This case presentation is common to hundreds of thousands of men every year. Surgery in most cases addresses obstructive symptoms only. If patients were only offered the chance to avoid surgical intervention by the use of our formula or other proven formula as the first line option, we'd all be better off. We may then determine validity on individual patients that shows we have something of value or on the other hand, surgery is in fact indicated despite the conservative effort. I had proposed a study comparing the effectiveness of microwave therapy to our prostate product. Not surprisingly, I have had no takers even given the academic interest of the topic. Limited research dollars preclude our independent review.

Collectively, we need to improve our diagnostic skills if we ever hope to conquer prostatitis management within the next decade. We need to start to recognize the need for other therapeutic options, as antibiotics do not work for all patients. In fact, they work on less than 5 % of all cases. Sound Familiar? This is the same dilemma we faced with prostate cancer treatment. ONE SIZE DOES NOT FIT ALL! Furthermore, many experts including David Bostwick, M.D., Pathologist trained at the Mayo Clinic, believe that prostatitis may lead to prostate cancer. I agree with him. Currently, urologists are confused about how to take care of prostatitis. 80% of urologists continue to prescribe antibiotics as their first line of therapy, this despite the fact that 95% of prostatitis cases are non-bacterial. Other therapies utilized without any proven merit include finasteride, (Proscar), alpha-blockade, (Cardura, Hytrin, or Flomax), and/or an anti-inflammatory. In an effort to bring clarity to this confusing but very important topic, I have invited physicians to compare their antibiotic first choice to our all-natural product in an open label randomized trial. Thus far, there is minimal interest.