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Monday, June 18, 2007

2007 AUA Update of Guidelines for Localized Prostate Cancer

[updated July 28, 2007]

The 2007 prostate cancer AUA guidelines have been released at this [link]. Since they are 81 pages plus appendices we have boiled it down to short excerpts for readers of this blog.

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.

Risk Strata:
- Low risk: PSA =10 ng/mL and a Gleason score of 6 or less and clinical stage T1c or T2a
- Intermediate risk: PSA >10 to 20 ng/mL or a Gleason score of 7 or clinical stage T2b but not qualifying for high risk
- High risk: PSA >20 ng/mL or a Gleason score of 8 to 10 or clinical stage T2c

The great disparity between cancer incidence and mortality indicates that many men may not benefit from definitive treatment of localized prostate cancer. Autopsy studies have shown that 60% to 70% of older men have some areas of cancer within the prostate.48, 49 This can be compared with the 15% to 20% of men diagnosed with prostate cancer during their lifetime and with the 3% lifetime risk of death from prostate cancer.

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 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 the 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 the 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 recurrence27, 35; • 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.10 [Based on review of the 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 recurrence27, 35 ; • When compared with watchful waiting, radical prostatectomy may lower the risk of cancer recurrence and improve survival.10 [Based on review of the 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.]

Patients who opt not to initially treat their prostate cancers may have differing expectations. For example, some may desire to monitor the tumor carefully on a program of active surveillance that includes frequent PSA and DRE testing and with regular repeat biopsies in order to intervene the moment that there is any evidence of tumor progression. Other men may have a greater focus on current quality-of-life issues, may have little interest in intervention, and may opt for more of a watchful waiting program. The follow-up schedule for these two aims will be different with more frequent and extensive evaluations in the former and fewer in the latter.

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 the 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 the 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 radiotherapy14;
- Based on outcomes of one randomized controlled clinical trial, when watchful Copyright © 2007 American Urological Association Education and Research, Inc.® 30 waiting and radical prostatectomy are compared, radical prostatectomy may be associated with a lower risk of cancer recurrence, cancer-related death, and improved survival10;
- Based on outcomes of two randomized controlled clinical trials, higher dose radiation may decrease the risk of PSA recurrence.27, 35 [Based on review of the 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 survival14;
- When compared with watchful waiting, radical prostatectomy may lower the
risk of cancer recurrence and improve survival10;
- For those considering external beam radiotherapy, higher dose radiation may decrease the risk of PSA recurrence.27, 35 [Based on review of the 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 Copyright © 2007 American Urological Association Education and Research, Inc.® 31 waiting and radical prostatectomy are compared, radical prostatectomy may be associated with a lower risk of cancer recurrence, cancer-related death, and improved survival10; • 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.11, 14 [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 survival10; and • For those considering external beam radiotherapy, use of hormonal therapy combined with conventional radiotherapy may prolong survival.11, 14 [Based on review of the data.]

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 ADT should be considered in the context of the existing comorbidities of the patient when choosing palliative ADT. [Based on Panel consensus.]

One crosssectional series reported rather high rates of urinary leakage for two
groups of patients treated with interstitial prostate brachytherapy (one group treated with interstitial prostate brachytherapy only, the other group treated with both interstitial prostate brachytherapy and external beam radiotherapy),78 but, in general, incontinence is less frequently observed in radiotherapy series. Incontinence is also less frequently observed in surveillance groups.79

There are 11 appendices spread over 170 pages ([link]) covering the following topics:

1. Prostate Cancer Clinical Guideline Panel Members and Consultants (1995)
2. Prostate Cancer Clinical Guideline Update Panel Members and Consultants (2007)
3. Glossary
4. American Joint Committee on Cancer (AJCC) Tumor, Nodes, Metastasis (TNM) Prostate Cancer Staging System
5. Expectation of Life by Age and Sex: United States, 2003
6. Details of the Article Selection Process
7. Article Extraction Form
8. Bibliography of Extracted Articles Listed by Primary Author
9. Efficacy Outcomes Graphs
10. Complication and Adverse-event Categories
11. Variability of Definitions of Biochemical Recurrence Reported in the Extracted Articles - Subcategorized by Initial Treatment

Readers interested in prostate cancer guidelines may also wish to look at the 2007 NCCN Guidelines. For advanced hormone sensitive cancer ASCO has guidelines [here].

Readers interested in the AUA may also wish to look at this post on AUA 2007 Conference Summaries.

1 comment:

garytennis said...

I'm at a loss for why this publication pretends that focal cryoablation - which is often ideal for low and intermediate risk localized prostate cancer - is utterly ignored in this publication as a monotherapy option. This is an outstanding option for those struggling with the decision between active surveillance and RP or radiation, in that it destroys the tumor cells while avoiding many of the life-compromising side effects of the more conventional therapies.

I had this done less than two months ago and am already enjoying an fulfilling sex life with my wife (we had intercourse 21 days after surgery, though admittedly just barely - it's almost back to normal now). Also, there was no incontinence whatsover, and the recovery was relatively easy compared to what my brother (had nerve-sparing prostatectomy) went through.

More importantly, the results published by Dr. Gary Onik show that this procedure is as, or more effective than conventional therapies (for those with localized pc), in avoiding recurrence.

Aside from the fact that the publication's readers deserve to be made aware of this option - at least so they can look into it - this omission has the additional unfortunate result of undermining the credibility of the publication, which is otherwise excellent.

Gary Tennis

Aside from the fact that readers of the publication deserve to be made a