THE Detection, Diagnosis, Evaluation & Treatment (D-D-E-T) of PC PREFACE: It is in the neighborhood of 50 years since the most significant advance was made by Drs. Huggins and Hodges who received the Nobel prize for medicine when they made the discovery that it was the male bodies production of Hormones that fed and proliferated Prostate Cancer. At that time the only method of treatment was Orchiectomy and the female hormone DES. DES was found to cause Cardiovascular disease, Thrombo Embolism and Phlebitis and more patients died from the treatment rather than the disease. It was abandoned and the methods of treatment (Radical Prostatectomy, Radiation and later Brachy Seed Implants were given the false title (The Gold Standard of Prostate Cancer Treatment) In the middle 80s the diligent research of Dr. Fernand Labrie at Center Hospital University of Laval (CHUL) in Quebec City, Canada isolated the Antiandrogen Flutamide a medication taken with an LHRH Agonist (Leutenizing Hormone Releasing Hormone) LHRH described as CHT (Combination Hormonal Therapy.) With the misleading and fallacious information being fed to the public on prostate cancer it is no wonder that both the potential cancer patient and the medical profession are in variance with the basics of Detection, Diagnosis, Evaluation and Treatments for the disease. Media quotes that the annual incidence of PC has increased by more than 100,015 since 1995 which is hardly conceivable even though reported by so called, "reliable sources" which was quoted in December of 1995 as being 200,000 new cases annually. An increase in prediction by over 100,000 is implausible. Many of the newly diagnosed patients could have been diagnosed years ago if the proper detection methods were instituted. We will never have reliable data until a national registry is mandatory for all forms of cancer with laws enforcing physician compliance within 30 days of detection. DETECTION The first consideration for the Detection of the disease should be involved in the currently most accurate method which is the PSA blood test which should be undertaken immediately after a man has had his 40th birthday. In the case where a man has a history of prostate cancer in the family, brother(s), father, grandfather, early detection is even more important, to commence annual PSA tests immediately after his 30th birthday. In addition Afro American males who have a 4 times incidence of the disease should also commence PSA detection at 30 years of age. It is better to be safe than sorry. How many patients’ lives could have been extended if the disease were detected in its earliest stages in the years prior to age 50 or even completely eliminated? No one knows. Our extensive records show that early detection is the key to extension of survival and reduction of disease mortality. Isn't it worth the effort to prolong your lifespan? More sophisticated blood tests such as PSA2 and RTPCR currently unapproved but in clinical trials are available and patient participation enables access to these tests, which at least, can provide additional guidelines as to the extent of the disease. Because abnormal PSA readings can be caused by (BPH) Benign Prostatic Hyperplasia as well as Prostatitis additional diagnostic procedures must be undertaken to affirm the presence of the disease when the upper limits of the age related PSA are exceeded. DRE (Digital Rectal Examinations) in and of themselves are useless in detecting PC. If there is a palpable nodule that can be felt through the rectal canal it may confirm an irregularity in the prostate gland due to BPH, Prostatitis or PC. Without confirmation by further testing it cannot be classified. The absence of a palpable nodule in no way confirms absence of prostate disease with elevated PSA. Although there are exceptions to every rule, a PSA reading of 9.0 is suspicious of extra-capsular activity in the periphery of the gland, or seminal vesicular involvement. PSA readings of 20+ indicate lymph node involvement and readings of 50+ are indicative or suspicious of bone or other organ penetration as well. DIAGNOSIS To properly diagnose condition of the gland a transrectal ultrasound, utilizing the most advanced equipment preferably by a doppler color enhanced unit which can obtain a superior image, enhancing the hypoechoic echogenicity in suspicious tumor areas that permits a needle GUIDED biopsy rather than multiple random biopsies should be undertaken. Should a positive biopsy result further confirmation of the extent of the disease by CT scan, and/or MRI in conjunction with an imaging enhancing agent such as CYT356 should be undertaken. Further blood tests such as PSA2 and RTPCR will more clearly define the extent of the disease. Additional data should be obtained for the patient's personal records. A ploidy analysis to determine the aggressiveness of the disease, the dimensions of the gland to help determine the presence of BPH which along with Prostatitis can create a rise in the PSA unrelated to PC. Once the diagnosis has confirmed the presence of the disease, treatment should be commenced with CHT Combination Hormonal Therapy. Mono Therapy, the administration of only one of the two LHRH without the anti- androgen medication can cause a tumor flare that would increase the volume of the disease and provide an exacerbation of the disease. In all cases both the gland size and tumor volume are reduced, making secondary therapy, if needed, much more effective. Low stage disease should be treated with a minimum of six months of CHT followed by a reevaluation to determine that the disease is confined to the gland and therefore the patient is a proper candidate for secondary localized therapy. More extensive disease should be treated with a minimum year of CHT before another reevaluation and metastatic disease two years. PSA should be monitored at regular intervals. The ignorant conclusion that an LHRH Agonist alone suffices because under normal conditions the testes produce 95% of the body's hormones indicates that the physician is ignorant of the endocrinological changes that take place in the body when a foreign substance is introduced. Monotherapy when administered can cause a severe tumor flare and an exacerbation of the disease. When mono therapy or the introduction of the LHRH Agonists without the administration of an Antiandrogen medication a day to a week before starting the LHRH occurs, the adrenal androgens are routed through the hyperthalmus to the pituitary gland where, by a 5 alpha reductase alteration they are converted to the powerful Di Hydro Testosterone (DHT) which elevates the hormone production from this source to 50%, a ten times increase from the body's normal conversion. When properly administered, the PSA count should be rapidly reduced to undetectable levels which only indicates that the disease activity has been halted. Continued CHT administration will reduce the gland and tumor volume and on reevaluation may permit secondary therapy such as Cryosurgery. Whatever the choice of therapy, it should always be preceded by a minimum of 6 months of CHT. EVALUATION In consideration of the knowledge of the patient, the knowledge, capability and experience of the attending physician, and the availability and use of the most up-to-date equipment a complete evaluation should be undertaken, with a written report be furnished to the patient outlining ALL treatment options available, not those that serve only the vested interests of the physician. Recent improvements in ultrasound equipment, namely Doppler Color Enhancement, permits a more definable hypoechoic echogenicity that makes it possible to provide a needle guided biopsy rather than multiple randomized biopsies which may miss the tumors entirely especially when they are small. Imaging enhancement with the use of CT scans and MRI can authenticate the presence of extra-capsular tumors and confirm metastases. Other evaluation procedures should be taken to provide additional data such as the PH values and a ploidy analysis that indicates the aggressiveness of the disease. Diploid designating non aggressive disease with Aneuploid or Tetraploid characteristics indicating more aggres-sive disease. Comparing the PSA value with the Partin tables can give a clue to whether the disease is localized or systemic. TREATMENT The most controversial aspects involving prostate cancer are the recommended methods of treatment which may be greatly influenced by the vested interests of the physician, the extent of their knowledge and experience with the treatments of the disease and their adherence to their hypocratic oath. The possession of an MD License or the title of Urologist does not insure that the physician is qualified to treat prostate cancer. Early detection is of paramount importance in the success of treatment of this number two cancer killer of men, which is rapidly approaching number one status. The notion that we can hold off treatment until symptoms appear is foolhardy and increases the likelihood that the patient's lifespan could be severely reduced, or his life be terminated in short order. Lack of adhering to the proper administration of treatment modalities can only be considered as malpractice and a violation of the patients constitutional rights and could contribute to the patients early demise. 1. Combination Hormonal Blockade: is the first and mandatory treatment regardless of the initial stage of the disease. Combination therapy by definition is the use of TWO, (2) medications, not 1. Both an LHRH Agonist, Lupron or Zoladex and an Antiandrogen, Flutamide, Casodex, Nizoral, Nilutamide or Cytadren with HC) - sequentially before a patient can be determined to be hormonally refractory. Patients with organ confined disease, confirmed by reevaluation may opt for secondary therapy such as Cryo, and RP if they are willing to accept the morbidity of a Radical Prostatectomy. No patient with metastatic disease qualifies for ANY form of local therapy. 2. Cryo prostatectomy: Option for secondary therapy for those who qualify. (Disease confined to the prostate gland.) 3. Brachy Seed Implantation: Option for those who qualify as above, and are willing to accept the potential morbidity. 4. Chemo Therapy: Mandatory for those who become Hormonally Refractory. Recom-mended medication: start with Velban and Emcyt. 5. Radical Prostatectomy: Only for those who have organ confined disease and are willing to accept the extreme morbidity, side effects created, the lengthy hospital confinement and exorbitant cost. 6. External Beam Radiation: Another morbid procedure that can damage or destroy normal tissue and create residual effects that can impede normal body functions until death. 7. Watchful Waiting: This attitude is promoted on the assumption that the patient's disease will remain dormant for an extended period of time. When there is evidence of the presence of the disease, if the patient agrees to accept the risks that he will be one of a small minority in whom the disease will remain dormant for a logical period of time, it is HIS decision. 8. Intermittent Therapy: If undetectable presence of the disease and a low PSA (less than 1.0) is accomplished after CHT this attitude may be considered. PSA must be monitored on a minimum 3 month frequency and if the PSA rises more than .75 in 2 consecutive blood tests, treatment must be resumed without delay. CAUTION: Hormonal refraction cannot be determined until all the CHT medications have been administered. Only then can hormonal therapy be considered refractory and Chemo-therapy be instituted. A list of the antiandrogens is contained in No.1. above. We highly advise that ALL patients maintain complete records of every visit to your physician(s), clinics, laboratories etc. After all, you are the patient, you are the one who has the disease, you are the one who is footing the bill whether it is by insurance, Medicare, Medicaid or cash. The money paid in to your HMO is for your treatment. Do not permit them to deny you your treatment of choice, nor the type of physician you prefer. Keep them in a safe place and when it is desirable to consult them see to it that they are in folders and in your briefcase in an easily accessible order. Remember you are in control of your own destiny. Protect your constitutional rights at all times. In considering the potential side effects of treatment we are forced to acknowledge the fact that NO two individuals are biologically constituted the same. Reactions to any form of treatment are not predictable except for generalization. The random classification of patients used to delay or postpone treatment are based on assumptions. Once the presence of the disease has been confirmed watchful waiting is only courting disaster and hormonal blockade should be com-menced immediately SIDE EFFECTS: Nearly all side effects have definitive methods of treatment. Some may have more than one. Some of the more common are: Gynecomastia - tenderness or enlargement of the breasts. Diarrhea - liquid stool Hot Flashes Impotence - termination of sexual abilities. Incontinence - uncontrollable urination Red blood corpuscle deficiency White blood corpuscle deficiency Pain New devises and medications are being introduced all the time, and as they are submitted to us we thoroughly investigate each to determine that there is sufficient evidence of authenticity before we will publish the relevant information in the Newsletter. There are those who will seize on the opportunity of promoting their own financial welfare by preying on the fact that the patient has been informed that they have a life-threatening disease and are prone to believe anything that they hear. It is abject stupidity that denies the efficacy of COMPLETE Hormonal Blockade as the initial form of treatment. CHT will down-stage both the prostate gland and the tumor volume. Don't believe all you hear and only half of what you see. On the other hand, you are the one in the driver's seat. ALTERNATIVE THERAPIES Recently Nov. 28, 1997 CNN broadcast a half hour news release on the merits of alternative therapies. The definition of ALTERNATIVE is "Instead of" which advocates a substitute for present acceptable methods of treatment. The definitive conclusion was that the promotion of these alternatives was MEDICAL FRAUD and patients were warned that the news releases and other methods used to influence patients to add to or substitute for proven treat-ment were invalid. In nearly all cases the same results were attained when NOT using the alternative medica-tions and equipment. It is true that there are self-interested individuals groups and organizations who will influence the legislative approval because it restricts their income and highlights their lack of knowledge. A good example of the incapability of the medical profession is displayed with the lack of approval of Cryosurgery. Of the 140 plus units currently in use and the dismal failures at over 100 centers offering the treatment, it is neither the treatment nor the equipment that is at fault. When one such center has treated over 600 patients with a 90+ percentage of success there must be a reason for such malpractice. Once again, we reiterate; it is the patients right to choose their physician, method of treatment, and be responsible for the eventual outcome. http://www.paactusa.org/page2.html