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Prostate Cancer
Introduction
Approximately 230, 000 new cases of prostate cancer are diagnosed in the United States annually, making it the most common cancer affecting American men besides superficial skin cancers. Although it is a highly curable malignancy when treated in its early stages, approximately 50-60, 000 men experience a relapse of the disease annually, and approximately 5-10% harbor advanced disease at the time of diagnosis, and are thus considered unable to be cured with surgery or radiation. Approximately 30, 000 American men die of the disease every year. Death rates from prostate cancer have been steadily declining since the 1990s, a result of the combination of early detection and improved treatment of localized disease as well as improved therapies for men with advanced disease.
Prostate cancer is a disease of the aging male, and the risk of developing the disease persists throughout a mans lifetime. While only 1 in 10, 000 men under age 40 will develop prostate cancer, the odds increase to 1 in 103 for those between the ages of 40-59, and 1 in 8 for those between the ages of 60-79. Certain population groups are at higher risk, including African Americans and those with a family history of the disease. Men with a first degree relative (brother, father, uncle) with prostate cancer have a higher likelihood of developing the disease, however mortality from the disease is not different from those with the sporadic form.
The epidemiology of the disease was altered substantially in the early 1990s with the onset of PSA (prostate-specific antigen) blood screening which resulted in a significant increase in the incidence of the disease. The spike in the incidence of the disease is mitigated, however, by the development of stage migration an effect where more men are diagnosed with earlier stage disease.
The successful management of prostate cancer is accomplished through a multidisciplinary approach that utilizes the expertise of urologists and medical and radiation oncologists. This article will focus on the types of cancer that arise in the prostate and the variety of treatment options that are available to men diagnosed with the disease. Some of the controversies and novel developments in the area of the management of localized disease will be discussed, as will the use of hormonal and chemotherapies.
Pathology
The prostate gland is approximately the size of a walnut and is located at the base of the bladder. The primary role of the prostate gland in male physiology is the secretion of the fluid components of semen. Thus, the most common type of cancer arising from the prostate comes from the glandular tissue a type of cancer known as an adenocarcinoma. Over 95% of prostate cancers are adenocarcinomas. Unlike adenocarcinomas that develop in other parts of the body (e.g., lung and colon), adenocarcinomas that arise in the prostate are stimulated to grow through the stimulation of androgen (e.g., testosterone) and express in high concentrations the androgen receptor (AR) which is activated by testosterone. Unless otherwise specified, all discussions of prostate cancer will concern adenocarcinoma. The remainder of prostate cancers are neuroendocrine (a.k.a. small cell) cancers and transitional cell carcinomas (arising from the special lining cells of the urinary tract - similar to bladder cancer). Sarcomas can also arise in the prostate gland but are exceedingly rare.
Natural History
The vast majority of diagnosed prostate cancers are confined within the prostate gland - and are thus termed localized disease a situation in which curative treatment is possible. The fatal form of the disease arises from the situation where the cancer has spread through the blood or lymph system to the bones (most commonly) or to other organs, such as the liver and lung (less common). Many patients who are diagnosed and treated for localized disease may harbor occult metastatic (distantly spread) disease in one or more of these other organs, which accounts for the 50, 000 or so relapses that occur in the US every year, and the vast majority of the 30, 000 annual deaths. Figure 1 shows the varied clinical states that are seen in the progression of prostate cancer.
Tumors that spread outside of the prostate gland typically do so by penetrating the capsule of the prostate along the routes of the nerves and/or invade the seminal vesicles (ducts for the transit of sperm to the urethra) and/or through the blood and lymph system. When the disease spreads locally, it can invade the bladder or the rectum, which is nearby.
The most common site of distant spread (metastasis) is bone, particularly the lumbar spine, femur, and pelvis. The development of metastatic disease in the bone represents a complex interplay between the tumor cells themselves, the bony tissues that harbor their growth, as well as hormones in the circulation and, as recent studies suggest, an attempt by the immune system to control the spread of the disease. In most situations when tumors grow in the bone, it begins as a painless process, however bone complications such as pain, fractures, and compression of the spinal cord can occur if the disease is not properly controlled. In many situations, the development of such bony complications can be prevented or delayed through the use of hormonal therapy, medicines such as bisphosphonates (e.g., Zoledronic acid), and radiation to metastatic sites with the potential to threaten the spinal cord.
Causes and Risk Factors of Prostate Cancer
It is likely that there is more than one underlying cause of prostate cancer, as there appear to be both genetic and environmental factors that contribute to its development. The role of genetics is an area of active investigation that will likely lead to significant advances in our ability to predict who will develop clinically significant prostate cancer. Such advances may lead to more accurate and detailed screening methods as well as molecular targeted therapies.
Testosterone (the male sex hormone) plays a critical role in the growth of prostate tumors but not necessarily in its onset. Prostate cells contain a special compound (enzyme) which is able to convert regular testosterone into a much more potent form, dehydrotestosterone (DHT). There are two drugs available that block the conversion of Testosterone to DHT, finasteride and dutasteride. There is good evidence from a large trial that finasteride can prevent prostate cancer in certain men who are at risk of developing the disease.
Further, blocking the interaction of testosterone and its derivatives with the androgen receptor (AR) form the basis for the most effective means of controlling the growth of advanced disease. The Nobel Prize for medicine was awarded to Huggins and Hodges, the two physicians who demonstrated in the 1940s, that castration (removal of the testicles) could improve the symptoms and prolong the lives of men with advanced prostate cancer. Many of the new medical therapies that have been developed or are in development for prostate cancer are derivations of this original approach.
Environmental influences also play a role in the development of the disease. Certain areas of the world (e.g., Asia) have a low incidence of prostate cancer, although individuals who migrate from such regions of low prostate cancer incidence to regions of higher incidence (e.g., North America) develop an increasing risk for prostate cancer, suggesting a dietary or environmental link. Factors common to the low incidence areas include a primarily low-fat, plant-based diets. Increased dietary amounts of animal fat, in particular, appear to be directly associated with prostate cancer.
Dietary components that potentially decrease the risk of prostate cancer:
lycopene ( present in cooked tomatoes)
selenium (a naturally occurring mineral)
omega-3 fatty acids (present in fish)
Vitamin E
Should Healthy Men be Screened for Prostate Cancer?
The majority of cases of prostate cancer are detected through combination of the PSA blood test along with the digital rectal exam (DRE) - the two components that form the basis of screening for the disease. Although it is generally accepted that the widespread use of PSA testing has led to a stage migration in the disease (more patients with low risk disease that is amenable to surgical or radiation treatment) there is controversy amongst the various public health associations as to whether PSA screening is to be recommended. The current recommendation of the Agency for Healthcare Research and Qualitys US Preventive Services Task Force is that insufficient evidence exists to recommend for or against routine prostate cancer screening. This view is shared by the American College of Physicians, but differs from the recommendations of the American Urological Association, whish recommends yearly screening for men after the age of 50 who have a life expectancy >10 years, and for those age 40 and older with a family history and for African American men. The AUA suggests offering screening as an option for patient in light of the potential risks (morbidity of biopsy and possible treatment methods) and benefits (finding a potentially curable cancer), ultimately leaving the decision up to the patient.
The crux of the issue regarding screening is that there may be a tendency for this procedure to over diagnose the disease - that is to diagnose early stage and non-aggressive disease that would, if not treated, have little effect on the quality of life and survival of the patient. As a result of this over-detection, many men face morbidity from the treatment (e.g., incontinence, impotence, bleeding and other surgical risks) of a disease that would be unlikely to harm them if left untreated.
The pace of change in a physicians ability to assess the disease risk of men with newly diagnosed prostate cancer, as well as the decline in the major side effects of treatment (incontinence, for example, is becoming less common with improved surgical techniques) have reduced the strength of this argument to some extent. That said, the results of randomized trials to determine the efficacy (or lack thereof) of PSA screening on decreasing the death rate from this disease are anticipated in the next few years.
A useful algorithm for screening has been developed by the National Comprehensive Cancer Network (NCCN - http://www.nccn.org ). These recommendations suggest that men undergo a baseline evaluation, including a medical history and physical examination, as well as a discussion of the risks and benefits of screening starting at age 40. Men who wish to pursue an early detection strategy should be offered a digital rectal exam (DRE) and a serum PSA test. If this first PSA is < 0.6, the panel recommends repeating the PSA at age 45. If the PSA is 0.6, the panel recommends annual follow-up with DRE and PSA testing. Following this algorithm, as long as the DRE remains normal, the PSA remains < 2.5 ng/mL, and the PSA velocity remains < 0.5 ng/mL/year, annual DRE and PSA testing should continue. A biopsy should be considered for those in whom the DRE remains normal but the PSA is between 2.5 ng/mL and 4.0 ng/mL or the PSA velocity is 0.5 ng/mL/year (factoring in age, comorbid conditions, family history, and racial background). For patients with a negative DRE but a PSA in the 4 ng/mL to 10 ng/mL range, the panel recommends proceeding to biopsy, or performing a test of free PSA (lower levels of which are associated with cancer) in cases where the biopsy may present a risk to the patient or if he has other comorbid conditions. All individuals with a PSA > 10 ng/mL and those with a suspicious DRE should undergo biopsy.
The range of the normal PSA increases with age. Because of this, recent recommendations suggest lowering the upper limit of normal to 2.5 ng/mL for men in their 40s and 50s. Others have recommended the use of age-adjusted PSA ranges whereby the upper-limit of normal is 2.5 ng/mL for men in their 40s, 3.5 ng/mL for men in their 50s, 4.5 ng/mL for men in their 60s, and 6.5 ng/mL for men in their 70s.
Diagnostic Testing
Symptoms - Most patients with early-stage prostate cancer do not have any symptoms of the disease and are diagnosed on the basis of screening. Urinary symptoms can occur which can be confused with the symptoms of benign prostatic hypertrophy (BPH) SPELL OUT. Bone pain, loss of appetite, weight loss, and fatigue are symptoms that can accompany metastatic disease. In rare but severe cases, nerve damage can occur, causing altered levels of sensation in the arms and legs, weakness in the legs, or a change in the level of bowel or bladder control.
Biopsy A prostate biopsy is considered when there is reasonable clinical suspicion based on DRE and PSA results that prostate cancer exists. Further considerations regarding the biopsy are that the patient have at least a 10-year life expectancy and he would consider a form of treatment if, in fact, prostate cancer were detected. Prostate biopsy is performed as a simple outpatient procedure with local anesthesia under ultrasound guidance. An enema is given prior to the procedure and it is followed by a short course of antibiotics. The procedure involves the insertion of a trans-rectal ultrasound (TRUS) probe into the patients rectum, allowing visualization of the gland. Subsequently 8-16 cores are obtained with a 15mm long core biopsy needle. It is recommended that, at a minimum, 12 core biopsy be used. Biopsy results may show cancer or other conditions that are not cancer per se but will require surveillance: these include atypical small acinar proliferation (ASAP) and high-grade prostatic intraepithelial neoplasia (HG PIN). Either one of these conditions merits close follow-up and repeat biopsies, as they may suggest a high risk for the development of cancer.
IMAGING
A variety of radiographic (X-ray) approaches are utilized in the workup of newly diagnosed and suspected prostate cancer. Many patients will undergo a bone scan to rule out the presence of metastatic disease in the bone prior to proceeding with local therapy with curative intent, or to determine the extent of disease outside of the prostate gland. Similarly, CT scans are often performed to exclude the presence of suspicious pelvic lymph nodes and metastases in the liver, in addition to being useful in the planning of treatment with radiation. A comprehensive TRUS (trans-rectal ultrasound) can also yield valuable information on the extent of the disease evidenced by the size of the prostate gland as well as the nearby seminal vesicles. An endorectal MRI scans can also be utilized to create accurate images of the prostate gland, but is currently utilized only in specialized centers. The ProstaScint scan utilizes a radioactively labeled monoclonal antibody to identify prostate cancer tissue, however due to relatively high false-positive and false-negative rates, this test is not used widely.
STAGING/GRADING
Tumor grade describes the appearance of prostate cancer under the microscope and the extent to which the tumor cells conform to the normal architecture of the gland or not. The most common grading system is the Gleason grading system in which 2 scores are derived and then summed. The tumors are assigned a number 1-5, where 1 represents the least aggressive appearing pattern and 5 represents the most aggressive appearing pattern. The Gleason score (or sum) is the combination of the primary and secondary Gleason grade, and is often quoted as such (e.g., Gleason 3 + 3=6) rather than simply stating the sum. The reason for this is that the primary Gleason has a very strong prognostic value, and therefore a Gleason 3+3 would be considered less aggressive than a Gleason 4+2. Gleason patterns 1 and 2 are very rarely found.
Tumor stage refers to the extent of cancer within the prostate gland and beyond. As with most cancers, the American Joint Committee on Cancers TNM (T = primary tumor, N = regional nodes, M = distant metastasis) staging system is utilized. The TNM staging system for prostate cancer was last revised in 2002. Appendix 1 shows the AJCC staging system for prostate cancer.
Treatment Strategies
Localized Prostate Cancer
Many treatment options are available for patients with localized, early stage prostate cancer. There is no clear, single treatment that is best applied to all patients, making this a much-debated topic because of successful outcomes with the various forms of treatment. Further, it would be nearly impossible to devise a randomized, head-to-head study that would assign patients to various treatment modalities and determine which is the most effective.
The vast majority of treatment decisions are made by clinicians in conjunction with their patients, taking into consideration the extent of the disease, the life expectancy of the patient, and the anticipated side-effect profile of the various treatment modalities. Treatment options include surgery (radical prostatectomy), radiation (external beam, brachytherapy with permanent implants, brachytherapy with temporary implants, cryotherapy, high-intensity focused ultrasound (HIFU), hormonal therapy, and active surveillance. Prediction tools called nomograms are available (online at www.nomograms.org), which can help patients and clinicians predict patients responses to the various forms of treatment based on the pretreatment parameters discussed above (Clinical stage, biopsy Gleason score, and diagnostic PSA level).
Watchful Waiting or Active Surveillance
The risk of disease progression is low in patients with Gleason scores 2-6 (with no pattern 4 or 5 present), T1 or T2a disease, and a serum PSA that is low and stable. Men with these features can be followed carefully and treated at the first sign of progression. Critical to the success of this approach is diligent surveillance and repeat biopsies (approximately yearly). Progression of the disease is determined by a significant rise in the PSA, a change in the DRE, or an increase in the Gleason sum. With this approach, approximately 20-40% of men will require treatment (surgery or radiation) within a 5-year period. Thus, active surveillance offers an opportunity to avoid, or delay the side effects of radical treatment. The standards of care for surveillance (e.g., when to treat and how frequently to repeat biopsies) are in the process of development. A study conducted in Sweden in which patients were randomly selected to have surgery or active surveillance found that by 10 years there was a significant difference in the death rate from prostate cancer, and an improvement overall in younger men (7, PSA >10 and larger tumors) appear to benefit from the inclusion of the pelvic lymph nodes in the radiation field.
For some patients, the results of radiation therapy can be further enhanced with the addition of Androgen Deprivation Therapy (ADT - see below) before and during radiation treatment.[1] In particular, ADT has been proven to improve the overall survival following radiation in patients with intermediate-risk (PSA 10 20, ng/ml, T2b, or Gleason score 7) or high-risk (PSA > 20 ng/ml, T3, or Gleason score 8, 9 or 10) disease. Relatively short term (4 6 months) of neoadjuvant and concurrent ADT is utilized for patients with intermediate risk disease, whereas those with higher risk features benefit from longer periods of therapy (24-36 months).
Radiation therapy also has side effects typically related to urinary, bowel, and sexual function. While men who undergo surgery are more likely to experience incontinence, men treated with radiation are more likely to suffer obstructive urination and bowel symptoms (diarrhea, rectal bleeding, hemorrhoids etc). Further, while surgery tends to have an early effect on sexual function, the effect of radiation on sexual function may not occur for up to 18 to 24 months. The sexual side effects of radiation are frequently exacerbated by the concurrent use of ADT.
Radiation Therapy brachytherapy; permanent implants.
Brachytherapy is a form of radiation in which seeds containing the radiation are permanently placed in the prostate gland. Permanent implants in the form of iodine-125 or palladium-103 radioactive seeds may be used. The procedure itself can be performed as an outpatient procedure, and no incisions are necessary. During the procedure, several needles loaded with the radioactive seeds are placed through the skin of the perineum. The radioactivity of the seeds decay rather quickly, reaching half-strength in 17 days (Palladium) or 60 days (Iodine).
Patients who are most likely to benefit from seed implantation are those with a small gland size (
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