This is the current release of the guideline.

This guideline updates a previous version: Loblaw DA, Mendelson DS, Talcott JA, Virgo KS, Somerfield MR, Ben-Josef E, Middleton R, Porterfield H, Sharp SA, Smith TJ, Taplin ME, Vogelzang NJ, Wade JL Jr, Bennett CL, Scher HI. American Society of Clinical Oncology recommendations for the initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer. J Clin Oncol 2004 Jul 15;22(14):2927-41.

Metastatic, recurrent, or progressive androgen-sensitive prostate cancer

To update the 2004 American Society of Clinical Oncology (ASCO) guideline on initial hormonal management of androgen-sensitive, metastatic, recurrent, or progressive prostate cancer (PCa)

Men with metastatic, recurrent, or progressive androgen-sensitive prostate cancer

Standard Initial Treatment Options

1. Bilateral orchiectomy
2. Medical castration with luteinizing hormone releasing hormone (LHRH) agonists
3. Diethylstilbestrol (DES) (no longer commercially available in North America and is not recommended as a standard first-line treatment option)
4. Patient education/counseling

Castration Alternatives

1. Nonsteroidal antiandrogen monotherapy (e.g., flutamide, nilutamide, and bicalutamide)
2. Steroidal antiandrogen (not recommended as monotherapy)

Combination Therapy

Medical or surgical castration plus a nonsteroidal antiandrogen

Early Androgen Deprivation Therapy versus Deferred Therapy (early therapy not strongly recommended)

Literature Review and Data Collection

For the 2006 update, the MEDLINE database (January 2003 through March 2006; National Library of Medicine, Bethesda, MD) was searched to identify relevant information from the published literature. A series of searches was conducted using the medical subject headings "prostatic neoplasms" and "androgen antagonists," and the text words "intermittent," "combined androgen," and "metastatic." These terms were combined with the following study design-related subject headings or text words: "meta-analysis," "systematic," trial," and "randomized." Search results were limited to human studies and English-language articles.

In addition, the Cochrane Database of Systematic Reviews was searched using the phrase "prostate cancer," and directed searches were made of the reference lists from primary articles. Authors were contacted for clarification where needed. The Physician Data Query clinical trials database (http://www.cancer.gov/search/clinical_trials/ ) was searched for ongoing clinical trials in the identified subject areas.

Inclusion and Exclusion Criteria

Table 1 in the original guideline document describes the details of the inclusion criteria and outcome variables for each question addressed in this guideline. For each guideline question, letters, editorials, and articles published in a language other than English were not considered. In addition, for questions 4 (early vs. deferred androgen deprivation therapy [ADT]) and 5 (intermittent versus continuous ADT), the following were excluded:

1. Participants previously treated with hormonal therapy
2. Randomized clinical trials targeting men undergoing radiation as primary therapy
3. Nonrandomized prospective studies
4. Retrospective studies
5. Trials or trial arms that used diethylstilbestrol

Seven randomized controlled trials (four new), one systematic review, one meta-analysis (new), one Markov model, and one delta-method 95% confidence interval (CI) procedure for active controlled trials (new) informed the guideline update.

Not applicable

Not stated

An evidence-based approach incorporating consensus by experts was the model used to create the recommendations. To this end, a subset of the original writing committee met via teleconference in February and March 2006 to consider the evidence for each of the 2004 recommendations. The guideline update was circulated in draft form to the full Expert Panel for review and approval. Suggestions from the Expert Panel were incorporated into the document, yielding a final set of recommendations.

Not applicable

One article was reviewed that showed early therapy is associated with higher costs and greater frequency of treatment-related adverse effects.

The draft guideline was submitted to the American Society of Clinical Oncology (ASCO) Health Services Committee (HSC) for review and was endorsed in July 2006. The ASCO Board reviewed and approved the document in November 2006. Final text editing was performed by two of the guideline authors.

A clinical algorithm is provided for the initial hormonal management of androgen-sensitive advanced cancer (see "Availability of Companion Documents" field in this summary).

The recommendations are supported by randomized controlled trials, a systematic review, a meta-analysis, one Markov model, and one delta-method 95% confidence interval (CI) procedure for active controlled trials.

Appropriate management of androgen-sensitive, metastatic, recurrent, or progressive prostate cancer

It is important to realize that many management questions have not been comprehensively addressed in randomized trials and guidelines cannot always account for individual variation among patients. A guideline is not intended to supplant physician judgment with respect to particular patients or special clinical situations and cannot be considered inclusive of all proper methods of care or exclusive of other treatments reasonably directed at obtaining the same results. Accordingly, the American Society of Clinical Oncology (ASCO) considers adherence to this guideline to be voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances. In addition, the guideline describes administration of therapies in clinical practice; it cannot be assumed to apply to interventions performed in the context of clinical trials, given that clinical studies are designed to test innovative and novel therapies in a disease and setting for which better therapy is needed. Because guideline development involves a review and synthesis of the latest literature, a practice guideline also serves to identify important questions for further research and those settings in which investigational therapy should be considered.

An implementation strategy was not provided.

Not applicable: The guideline was not adapted from another source.

American Society of Clinical Oncology (ASCO)

American Society of Clinical Oncology (ASCO) Metastatic Prostate Cancer Expert Panel

Primary Authors: D. Andrew Loblaw; Katherine S. Virgo; Robert Nam; Mark R. Somerfield; Edgar Ben-Josef; David S. Mendelson; Richard Middleton; Stewart A. Sharp; Thomas J. Smith; James Talcott; Maryellen Taplin; Nicholas J. Vogelzang; James L. Wade III; Charles L. Bennett; Howard I. Scher

ASCO Metastatic Prostrate Cancer Expert Panel: Howard I. Scher, MD, Cochair Memorial Sloan-Kettering Cancer Center; Charles L. Bennett, MD, PhD, Cochair VA Chicago Health Care System-Lakeside and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Edgar Ben-Josef, MD, Wayne State University; D. Andrew Loblaw, MD, MSc, Sunnybrook Health Sciences Centre; David S. Mendelson, MD, Premiere Oncology of Arizona; Richard Middleton, MD, University of Utah Medical School; Robert Nam, MD, MSc, Sunnybrook Health Sciences Centre; Thomas J. Smith, MD, Massey Cancer Center, Medical College of Virginia; Stewart A. Sharp, MD, Danville Hematology & Oncology, Inc; James Talcott, MD,MPH, Massachusetts General Hospital; Maryellen Taplin, MD, Dana-Farber Cancer Institute; Katherine S. Virgo, PhD, Saint Louis University & Department of Veterans' Affairs Medical Center; Nicholas J. Vogelzang, MD, University of Chicago Cancer Research Center; James L. Wade III, MD, Cancer Care Specialists of Central Illinois

Although all authors completed the disclosure declaration, the following authors or their immediate family members indicated a financial interest.

No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment: N/A Leadership: N/A Consultant: D. Andrew Loblaw, Astra Zeneca; Nicholas J. Vogelzang, Sanofi Aventis; Charles L. Bennett, Sanofi, Millenium Stock: N/A Honoraria: D. Andrew Loblaw, Astra Zeneca; James Talcott, Dendreon; Maryellen Taplin, Astra Zeneca; Nicholas J. Vogelzang, Astra Zeneca Research Funds: D. Andrew Loblaw, Astra Zeneca; Nicholas J. Vogelzang, Astra Zeneca; Charles L. Bennett, Amgen, Sanofi Testimony: N/A Other: D. Andrew Loblaw, Astra Zeneca, Sanofi-Aventis

This is the current release of the guideline.

This guideline updates a previous version: Loblaw DA, Mendelson DS, Talcott JA, Virgo KS, Somerfield MR, Ben-Josef E, Middleton R, Porterfield H, Sharp SA, Smith TJ, Taplin ME, Vogelzang NJ, Wade JL Jr, Bennett CL, Scher HI. American Society of Clinical Oncology recommendations for the initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer. J Clin Oncol 2004 Jul 15;22(14):2927-41.

Electronic copies: Available in Portable Document Format (PDF) from the American Society of Clinical Oncology (ASCO) Web site .

Print copies: Available from American Society of Clinical Oncology, Cancer Policy and Clinical Affairs, 1900 Duke Street, Suite 200, Alexandria, VA 22314; E-mail: guidelines@asco.org.

The following are available:

• American Society of Clinical Oncology (ASCO) treatment algorithm for the initial hormonal management of androgen-sensitive advanced cancer: 2007 update. Available from the ASCO Web site . See the related QualityTool summary on the Health Care Innovations Exchange Web site .
• Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2007 update. Slide set. Available from the ASCO Web site . See the related QualityTool summary on the Health Care Innovations Exchange Web site .
• ASCO 2007 guideline update: recommendations for the initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer. Revisions Table. Available from the ASCO Web site . See the related QualityTool summary on the Health Care Innovations Exchange Web site .

Guidelines are available for Personal Digital Assistant (PDA) download from the ASCO Web site .

The following is available:

• American Society of Clinical Oncology (ASCO) patient guide: hormone therapy for advanced prostate cancer. Available from the Cancer.Net Web site . See the related QualityTool summary on the Health Care Innovations Exchange Web site .

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

This NGC summary was completed by ECRI on August 11, 2004. The information was verified by the guideline developer on August 13, 2004. This NGC summary was updated by ECRI Institute on June 26, 2007. The updated information was verified by the guideline developer on July 16, 2007.

This summary is based on the original guideline, which is subject to the American Society of Clinical Oncology's copyright restrictions.