Prostate cancer is referred to as stage II if it can be detected with a digital rectal exam (physical exam) but there is no evidence that the cancer has spread outside the prostate to other organs. Stage II disease may also be further divided into the following depending on how much tissue is involved in the tumor (cancer):
- T2a: The tumor involves half or less of a lobe (section) of the prostate.
- T2b: The tumor involves half or more of a lobe of the prostate, but the other section isn’t involved at all.
- T2c: The tumor involves both lobes of the prostate.
Prostate cancer is referred to as stage II cancer when the cancer can be detected by digital rectal examination (DRE) or an elevated prostate-specific antigen (PSA), but there is no evidence that the cancer has spread outside the prostate to other organs.
A variety of factors ultimately influence a patient’s decision to receive treatment of cancer. The purpose of receiving cancer treatment may be to improve symptoms through local control of the cancer, increase a patient’s chance of cure, or prolong a patient’s survival. The potential benefits of receiving cancer treatment must be carefully balanced with the potential risks of receiving cancer treatment.
The following is a general overview of the treatment of stage II prostate cancer. Circumstances unique to your situation and prognostic factors of your cancer may ultimately influence how these general treatment principles are applied. The information on this Web site is intended to help educate you about your treatment options and to facilitate a mutual or shared decision-making process with your treating cancer physician.
Most new treatments are developed in clinical trials. Clinical trials are studies that evaluate the effectiveness of new drugs or treatment strategies. The development of more effective cancer treatments requires that new and innovative therapies be evaluated with cancer patients. Participation in a clinical trial may offer access to better treatments and advance the existing knowledge about treatment of this cancer. Clinical trials are available for most stages of cancer. Patients who are interested in participating in a clinical trial should discuss the risks and benefits of clinical trials with their physician. To ensure that you are receiving the optimal treatment of your cancer, it is important to stay informed and follow the cancer news in order to learn about new treatments and the results of clinical trials.
Prostate cancer is typically a disease of aging. It may persist undetected for many years without causing symptoms. In fact, most men die with prostate cancer, not from prostate cancer. Management or treatment of early stage prostate cancer is one of the most difficult and perplexing dilemmas for both patients and physicians. Patients with stage II prostate cancer are curable and have a number of treatment options, including surgical removal of the cancer, radiation therapy or “watchful waiting” without immediate treatment. It is important for patients to obtain as much information as possible about the results of each treatment modality and to obtain more than one opinion on the matter, especially when deciding on surgery versus radiation therapy.
If prostate cancer is truly confined to the prostate, it is curable with surgery or radiation. However, in order to benefit from curative treatment, a patient’s life expectancy may need to be 10-15 years. Patients may ask themselves: If cure is possible, is it necessary? Treatment of prostate cancer is a very personal decision and some patients will choose to undergo aggressive treatment, while others will not.
Patients diagnosed with early stage prostate cancer must choose between “watchful waiting”, more aggressive treatment with radiation or surgery (radical prostatectomy), or participation in a clinical study. Unfortunately, well-controlled clinical studies comparing these treatment approaches have not been performed. Before deciding on receiving treatment, patients should ensure they understand the answers to 3 questions:
- What is my life expectancy and risk of cancer progression without treatment?
- How will my prognosis be improved with treatment?
- What are the risks of the various treatment alternatives?
Before making treatment recommendations, physicians who treat prostate cancer consider a number of aspects about the patient’s disease that help predict whether the cancer is confined to the prostate (potentially curative) and how fast the cancer will grow. These aspects include the clinical stage of the cancer, the prostate-specific antigen (PSA) level, and the appearance of the prostate cancer cells under the microscope (the Gleason score). Patients with early stage cancer, lower PSA levels and a low Gleason score have more treatment options available and a better chance of long-term survival.
In 1997, researchers analyzed the outcomes of 57,876 men diagnosed with prostate cancer between 1983 and 1992 who were treated with either surgery (radical prostatectomy), radiation therapy or conservative management (“watchful waiting”). In the absence of clinical studies directly comparing treatments, the results of this analysis provide a useful framework for evaluating treatment options for early stage prostate cancer and discussing the appropriate course of action with your physician.
It is important to consider two things when evaluating the results of this analysis. The first is that this study did not directly compare treatment options in a controlled manner. The decision to receive a specific treatment was made between a patient and his treating physician. This is important to understand because patients electing to be treated with radiation or conservative management were more likely to have other medical illnesses and were on average 5 years older than patients electing to be treated with surgical prostatectomy. Secondly, this analysis reflects the outcomes of patients treated with therapy between 1983 and 1992. Treatment options continue to change and may currently produce a better outcome than reported in this analysis.
|EARLY STAGE I & II PROSTATE CANCER: 10 Year Cancer Specific Survival|
Patients with low Gleason scores had similar survival whether they were treated with “watchful waiting”, surgery or radiation. Patients with high Gleason scores appeared to do somewhat better if treated with prostatectomy or radiation compared to conservative management. Patients with high Gleason scores treated with prostatectomy or radiation experienced better survival as early as 5 years from initiation of treatment compared to patients treated with a conservative approach.
Some physicians and patients choose a strategy of delaying any treatment of prostate cancer until symptoms from the cancer appear. This delayed approach is referred to as “watchful waiting” or “conservative management” of prostate cancer. Because treatment with radiation or surgery may be associated with temporary (and some permanent) side effects, in addition to inconvenience, electing not to receive immediate treatment may be appropriate for selected patients. In fact, doctors in many European countries use a strategy of watchful waiting and do not treat early stage prostate cancer with radiation or surgery. No clinical study has ever been performed that directly compares surgery or radiation to watchful waiting. Doctors from Sweden, however, have reported that only 15% of patients with stage I-II prostate cancer managed with a watchful waiting approach die from prostate cancer within 10 years of diagnosis. Elderly patients and/or those with other significant medical problems may experience greater side effects from treatment and are more likely to die from causes other than prostate cancer. Thus, although many patients may require hormonal therapy or radiation therapy for relief of symptoms that may occur in the future, radical prostatectomy may not be necessary for men with a life expectancy shorter than one decade.
Recently, the results of data collected by the Cancer of the Prostate Strategic Urological Research Endeavor (CAPSURE) were evaluated. The data involved 329 men with localized prostate cancer who elected watchful waiting as their initial therapy. Five years after diagnosis, 52% of these patients showed progression of their cancer and underwent treatment. Significant predictors of cancer progression after diagnosis were patients with an age less than 65 years and an elevated PSA level. In fact, PSA level in a patient was the dominant predictor of cancer progression. The results of this study indicate that men who choose watchful waiting as their initial treatment option need frequent and routine follow-ups, as over half of these patients had a progression of their cancer within 5 years of diagnosis. In addition, men under 65 years and/or with an elevated PSA level should carefully consider the risks and benefits of watchful waiting, as these are the two significant predictors of cancer progression.
Watchful waiting requires close follow-up of the cancer, and therapy is only initiated when the cancer shows signs of having spread. At this point, the treatment typically consists of hormone therapy. There is still controversy over the optimal time to start hormonal therapy, i.e., is it better to treat early or to wait until there is progression of cancer. Asking your physician to explain your chance of survival without treatment and the risk of cancer having spread beyond the prostate capsule will help you make your decision.
Radical prostatectomy involves surgical removal of the prostate gland and a small amount of surrounding normal tissue. Surgical removal of the prostate is a very effective therapy if the cancer has not spread beyond the prostate.
Over 90% of patients with low-risk (stage I, PSA less than 10/ng/mL, Gleason less than 6) prostate cancer treated with radical prostatectomy will survive 5 years after surgery and most patients who die do so of causes other than prostate cancer. On the other hand, 30-70% of patients with Gleason scores greater than 6 and higher PSA levels will experience disease recurrence within 5 years of radical prostatectomy.
This is because some patients diagnosed with stage I cancer already have small amounts of cancer that have spread outside the prostate and were not removed by surgery. Undetectable areas of cancer outside the prostate gland are referred to as micrometastases. The presence of micrometastases may cause the relapses that follow treatment with surgery alone. Both radiation therapy and surgery are considered local therapies. They do not treat cancer that has spread away from the prostate gland. An effective treatment is needed to cleanse the body of micrometastases in order to improve the cure rate achieved with surgical removal of the cancer. Efforts are currently underway to find such a therapy. To learn more about radical prostatectomy and its side effects, select Surgery.
Radiation therapy is treatment with high energy x-rays that have the ability to kill cancer cells. Standard radiation therapy utilizes either external beam radiation (EBRT) consisting of daily treatments on an outpatient basis for approximately 6 to 8 weeks or interstitial brachytherapy which involves permanent placement of radioactive seeds directly into the prostate gland. Radioactive implants are increasingly being used instead of radical prostatectomy or EBRT. Unfortunately, clinical studies directly comparing EBRT to implants have not been performed. Early results with implants suggest good control of disease with limited side effects. Long-term results are not widely available, but early results are promising, especially in patients with low risk disease.
Over 90% of patients with low risk (stage I, PSA less than 10/ng/mL, Gleason less than 6) prostate cancer treated with EBRT will survive 5 years after treatment and most patients who die do so of causes other than prostate cancer. On the other hand, 40-65% of patients with Gleason scores greater than 6 and high PSA levels will experience disease recurrence by 5 years following radiation.
This is because some patients diagnosed with stage I cancer already have undetectable amounts of cancer that have spread outside the prostate (micrometastases) and were not treated by radiation. Both radiation therapy and surgery are considered local therapies. They do not treat cancer that has spread away from the prostate gland. An effective treatment is needed to cleanse the body of micrometastases in order to improve the cure rate achieved with radiation of the cancer. Efforts are currently underway to find such a therapy.
Because radiation implants focus the radiation closely around the prostate, this form of radiation works best in patients with early stage prostate cancer. If the PSA level or Gleason score is high, another form of treatment may be better suited for the patient. Patients with a large prostate gland, prior history of prostate infections or recent transurethral resection of the prostate (TURP) may not be able to undergo the implantation procedure for brachytherapy. To learn more about the risks and benefits of EBRT and implants, select Radiation Therapy.
The decision to undergo radical prostatectomy, EBRT or radiation seed implantation is difficult. This is because these treatment strategies have never been directly compared in well-designed clinical studies. The choice of radiation versus prostatectomy is often based on weighing the possible complications of treatment and the relative inconvenience of the treatments. It is important to be seen by more than one physician to determine the likely treatment outcome associated with the various options available in your community. Questions you may wish to ask your physicians include:
- What are the chances of this treatment curing the cancer?
- What is the risk of impotence and incontinence?
- What are the other possible complications from this treatment?
In 1998, researchers reported the results of a review of 1,872 patients with early stage prostate cancer who were treated with radical prostatectomy, EBRT or interstitial implantation at the University of Pennsylvania Medical Center and Harvard Medical School. High-risk patients (patients least likely to have cancer confined to the prostate; high Gleason score; high PSA; large prostate) treated with implantable seeds were more than twice as likely to experience cancer recurrence within 3-4 years of treatment compared to patients treated with radical prostatectomy or EBRT. Approximately 60% of patients treated with prostatectomy or EBRT survived without evidence of cancer recurrence compared to approximately 35% of patients treated with implants. Patients at low risk (those with a high chance of having cancer confined to the prostate; low Gleason score; low PSA) did equally well 3-4 years from treatment whether they received EBRT, radical prostatectomy, or radiation using implantable seeds.
In summary, for patients with low-risk, early stage prostate cancer, treatment with radical prostatectomy, EBRT or implants appears to produce equivalent results. It is important to realize that patients with low-risk disease have not been followed long enough to conclude there is no long-term difference between these 3 therapeutic approaches. In patients with high-risk disease, however, treatment with EBRT or radical prostatectomy appears to produce superior results compared to implants. Lastly, this was not a direct comparison of 3 different treatment approaches in a controlled fashion and a number of other factors could influence the outcome of the various treatment options. Hopefully, the results of this clinical analysis will help men and their families make more informed decisions as they sort through the maze of prostate cancer treatment options.
One reason that many patients will opt for the strategy of watchful waiting is that both surgery and radiation are associated with unpleasant side effects, including urinary problems and erectile dysfunction. While the urinary problems and other less significant side effects typically disappear within a year of treatment, erectile dysfunction can be an ongoing, long-term problem.
In one recent study, researchers evaluated data from 802 patients diagnosed with prostate cancer. The group included patients who had been treated with radical prostatectomy or external beam radiation therapy, as well as those who opted for a strategy of watchful waiting. They found that patients who chose watchful waiting had the lowest risk of erectile dysfunction. More than 80% of the patients who were treated with radical prostatectomy or radiation therapy suffered from erectile dysfunction. The researchers found that external beam radiation therapy and radical prostatectomy both presented equal risks of erectile dysfunction.
The progress that has been made in the treatment of prostate cancer has resulted from improved development of radiation treatments and surgical techniques. Despite improvements in treatment, patients still succumb to the complications of prostate cancer. Surgery and radiation are local therapies directed at treating cancer in and around the prostate gland. Future progress in the treatment of prostate cancer will result from continued participation in appropriate clinical studies designed to improve local and systemic treatment of prostate cancer. Currently, there are several areas of active exploration aimed at improving the treatment of stage II prostate cancer.
Strategies to Improve Local Treatment: Several strategies to improve local treatment of prostate cancer are under evaluation. These strategies only treat cancer confined to the prostate. They do not treat cancer cells beyond the radiation or surgical field.
Newer Radiation Techniques: EBRT can be delivered more precisely to the prostate gland by using a special CT scan and targeting computer. One exciting technique is the use of three-dimensional (3-D) computer targeting systems to precisely aim the radiation beam at the prostate gland. Through sophisticated software, a 3-D image or “beam’s-eye view” of the cancer is generated. Many thin beams of intense X-rays are then aimed at different angles to intersect at all cross-sections of the cancer. This method delivers a concentrated dose directly to the cancer, while the individual beams leave normal, healthy tissue relatively unscathed. This 3-D conformal radiation therapy technique appears to reduce side effects to the surrounding organs, thereby allowing higher radiation doses.
Recently, researchers from Memorial Sloan-Kettering Cancer Center conducted a clinical trial evaluating differing doses of 3-D conformal radiation therapy for prostate cancer that has not extended beyond the prostate. Patients were divided into 3 groups according to their risk of experiencing a cancer recurrence (favorable, intermediate, unfavorable). This was determined by the combination of Gleason score (aggressiveness of cancer cells), PSA levels (protein produced by the prostate), and clinical stage (extent of cancer). Five years following therapy, 85% of patients in the favorable group, 58% of patients in the intermediate group and 38% of patients in the unfavorable group survived without a cancer recurrence. The most powerful predictor to impact cancer-free survival in each group of patients was the dose of radiation, with the highest doses associated with superior outcomes. Treatment was associated with few side effects.
Combination Radiation Therapy: Some radiation oncologists are combining EBRT and interstitial seed brachytherapy for patients with stage II or III cancers. The purpose of the EBRT is to treat the tissues surrounding the prostate gland and lymph nodes where cancer cells may have spread. The interstitial seeds serve to deliver extra radiation dose to the prostate where the cancer cells are greatest. The combination of internal and external radiation is being evaluated to allow higher doses of radiation to the cancer while minimizing side effects to surrounding organs.
Researchers recently evaluated the effectiveness of brachytherapy plus EBRT versus EBRT alone in the treatment of over 300 patients with advanced localized prostate cancer. Half of the patients received treatment consisting of both brachytherapy and EBRT and the other half received EBRT alone. Five years following treatment, high PSA levels existed in only 33% of patients that had received the combination of brachytherapy plus EBRT, compared to 56% of patients that received EBRT alone. Since high PSA levels are an indication of the presence of cancer, these results suggest that brachytherapy plus EBRT may be more effective than EBRT alone in the treatment of advanced localized prostate cancer.
Newer Radiation Machines: Most EBRT uses high energy x-rays to kill cancer cells. Some radiation oncology centers use different types of radiation that require special machines to generate. These different types of radiation, such as protons or neutrons, appear to kill more cancer cells with the same dose. Combining protons or neutrons with conventional x-rays is one method of radiation therapy being evaluated in clinical trials.
Newer Imaging Techniques: The ability of current imaging technology to detect small areas of cancer within and around the prostate gland and elsewhere in the body is limited. Magnetic resonance imaging, or MRI, provides better images of the prostate gland and is able to locate small growths of cancer. The MRI can be used to guide interstitial seed placement or determine which patients are best suited for radical prostatectomy.
Strategies to Improve Systemic Therapy: Surgery and radiation are local therapies directed at treating cancer in and around the prostate gland. Treatment administered before or after surgical removal of the cancer is referred to as adjuvant or neoadjuvant therapy. Over the past several years, many new anti-cancer drugs and biologic agents have been discovered that are more active at destroying cancer cells. It may be that these newer anti-cancer agents administered before or after surgical removal of stage I prostate cancer will be beneficial. These newer anti-cancer agents are currently being evaluated in patients at high risk of cancer recurrence.
Neoadjuvant Hormone Therapies: Hormone therapy deprives a man’s body of male hormones necessary for prostate cancer to grow. The use of hormone therapy to shrink the prostate cancer prior to radical prostatectomy or radiation therapy is being evaluated for patients with early stage prostate cancer. Hormonal therapy prior to radiation therapy results in an average 20% shrinkage of prostate volume. This volume reduction may reduce the number of prostate cancer cells and diminish the volume irradiated decreasing the side effects.
Since metastases are the first manifestation of disease recurrence in many patients with prostate cancer, the use of early hormonal therapy may possibly delay or even prevent the development of metastatic disease.
Antiandrogens: Prostate cancer cells are stimulated to grow by male hormones, mainly testosterone. Antiandrogens are agents that block the availability of testosterone to cancer cells. Bicalutamide is an antiandrogen that works by binding to the testosterone receptors so that no receptors are free for testosterone to bind to and the process for growth stimulation is halted.
A multi-institutional clinical trial was conducted evaluating the effects of bicalutamide in over 8,000 men with early stage prostate cancer (cancer confined to the prostate or nearby tissues). Patients were divided into 2 groups – those receiving bicalutamide and those receiving a placebo (non-active substitute). All the patients in this trial had received primary therapy of radiation therapy, radical prostatectomy or watchful waiting. Three years following the initiation of this trial, patients receiving bicalutamide had a reduced risk of cancer progression of 42% compared with patients who had received placebo, regardless of which primary treatment the patient had received. Progression was determined by bone scans, CT scans, MRI or ultrasound. Side effects included breast pain and gynecomastia (enlargement of breasts), but were reported as mild to moderate.
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