Grades of the guideline statements (Standard, Recommendation, Option) are defined at the end of the "Major Recommendations" field.
Initial Evaluation and Discussion of Treatment Options with the Patient
Standard: An assessment of the patient's life expectancy, overall health status, and tumor characteristics should be undertaken before any treatment decisions can be made. [Based on review of data and Panel consensus.]
Treatment Alternatives
Standard: A patient with clinically localized prostate cancer should be informed about the commonly accepted initial interventions including, at a minimum, active surveillance, radiotherapy (external beam and interstitial), and radical prostatectomy. A discussion of the estimates for benefits and harms of each intervention should be offered to the patient. [Based on Panel consensus].
Treatment Recommendations
Treatment of the Low-Risk Patient
Option: Active surveillance, interstitial prostate brachytherapy, external beam radiotherapy, and radical prostatectomy are appropriate monotherapy treatment options for the patient with low-risk localized prostate cancer. [Based on review of data and Panel consensus.]
Standard: Patient preferences and health conditions related to urinary, sexual, and bowel function should be considered in decision making. Particular treatments have the potential to improve, to exacerbate or to have no effect on individual health conditions in these areas, making no one treatment modality preferable for all patients. [Based on review of data and Panel consensus.]
Standard: When counseling patients regarding treatment options, physicians should consider the following:
- Two randomized controlled clinical trials show that higher dose radiation may decrease the risk of PSA recurrence (Pollack et al., 2002; Zeitman et al., 2005)
- Based on outcomes of one randomized controlled clinical trial, when watchful waiting and radical prostatectomy are compared, radical prostatectomy may be associated with a lower risk of cancer recurrence, cancer-related death, and improved survival (Bill-Axelson et al., 2005). [Based on review of data and Panel consensus.]
Standard: Patients who are considering specific treatment options should be informed of the findings of recent high-quality clinical trials, including that:
- For those considering external beam radiotherapy, higher dose radiation may decrease the risk of PSA recurrence (Pollack et al., 2002; Zeitman et al., 2005)
- When compared with watchful waiting, radical prostatectomy may lower the risk of cancer recurrence and improve survival (Bill-Axelson et al., 2005). [Based on review of data and Panel consensus.]
Standard: For patients choosing active surveillance, the aim of the second-line therapy (curative or palliative) should be determined and follow-up tailored accordingly. [Based on Panel consensus.]
Treatment of the Intermediate-Risk Patient
Option: Active surveillance, interstitial prostate brachytherapy, external beam radiotherapy, and radical prostatectomy are appropriate treatment options for the patient with intermediate-risk localized prostate cancer. [Based on review of data and Panel consensus.]
Standard: Patient preferences and functional status with a specific focus on functional outcomes including urinary, sexual, and bowel function should be considered in decision making. [Based on review of data and Panel consensus.]
Standard: When counseling patients regarding treatment options, physicians should consider the following:
- Based on outcomes of one randomized controlled clinical trial, the use of neoadjuvant and concurrent hormonal therapy for a total of six months may prolong survival in the patient who has opted for conventional dose external beam radiotherapy (D'Amico et al., 2004)
- Based on outcomes of one randomized controlled clinical trial, when watchful waiting and radical prostatectomy are compared, radical prostatectomy may be associated with a lower risk of cancer recurrence, cancer-related death, and improved survival (Bill-Axelson et al., 2005)
- Based on outcomes of two randomized controlled clinical trials, higher dose radiation may decrease the risk of PSA recurrence (Pollack et al., 2002; Zeitman et al., 2005). [Based on review of data and Panel consensus.]
Standard: Patients who are considering specific treatment options should be informed of the findings of recent high-quality clinical trials, including that:
- For those considering external beam radiotherapy, the use of hormonal therapy combined with conventional-dose radiotherapy may prolong survival (D'Amico et al., 2004)
- When compared with watchful waiting, radical prostatectomy may lower the risk of cancer recurrence and improve survival (Bill-Axelson et al., 2005)
- For those considering external beam radiotherapy, higher dose radiation may decrease the risk of PSA recurrence (Pollack et al., 2002; Zeitman et al., 2005). [Based on review of data and Panel consensus.]
Standard: For patients choosing active surveillance, the aim of the second-line therapy (curative or palliative) should be determined and follow-up tailored accordingly. [Based on Panel consensus.]
Treatment of the High-Risk Patient
Option: Although active surveillance, interstitial prostate brachytherapy, external beam radiotherapy, and radical prostatectomy are options for the management of patients with high-risk localized prostate cancer, recurrence rates are high. [Based on review of the data.]
Standard: When counseling patients regarding treatment options, physicians should consider the following:
- Based on outcomes of one randomized controlled clinical trial, when watchful waiting and radical prostatectomy are compared, radical prostatectomy may be associated with a lower risk of cancer recurrence, cancer-related death, and improved survival (Bill-Axelson et al., 2005)
- Based on results of two randomized controlled clinical trials, the use of adjuvant and concurrent hormonal therapy may prolong survival in the patient who has opted for radiotherapy (Bolla et al., 2002; D'Amico et al., 2004). [Based on review of the data.]
Standard: High-risk patients who are considering specific treatment options should be informed of findings of recent high-quality clinical trials, including that:
- When compared with watchful waiting, radical prostatectomy may lower the risk of cancer recurrence and improve survival (Bill-Axelson et al., 2005)
- For those considering external beam radiotherapy, use of hormonal therapy combined with conventional radiotherapy may prolong survival (Bolla et al., 2002; D'Amico et al., 2004). [Based on review of the data.]
Additional Treatment Guidelines
Recommendation: Patients with localized prostate cancer should be offered the opportunity to enroll in available clinical trials examining new forms of therapy, including combination therapies, with the goal of improved outcomes. [Based on Panel consensus.]
Recommendation: First-line hormone therapy is seldom indicated in patients with localized prostate cancer. An exception may be for the palliation of symptomatic patients with more extensive or poorly differentiated tumors whose life expectancy is too short to benefit from treatment with curative intent. The morbidities of androgen deprivation therapy (ADT) should be considered in the context of the existing comorbidities of the patient when choosing palliative ADT. [Based on Panel consensus.]
Definitions:
Grades of Guideline Statements
Standard: A guideline statement is a standard if: (1) the health outcomes of the alternative interventions are sufficiently well known to permit meaningful decisions, and (2) there is virtual unanimity about which intervention is preferred.
Recommendation: A guideline statement is a recommendation if: (1) the health outcomes of the alternative interventions are sufficiently well known to permit meaningful decisions, and (2) an appreciable but not unanimous majority agrees on which intervention is preferred.
Option: A guideline statement is an option if: (1) the health outcomes of the interventions are not sufficiently well known to permit meaningful decisions, or (2) preferences are unknown or equivocal.
