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Absolute Prostate-Specific Antigen Value After Androgen Deprivation Is a Strong Independent Predictor of Survival in New Metastatic Prostate Cancer: Data From Southwest Oncology Group Trial 9346 (INT-0162)

Maha Hussain, Catherine M. Tangen, Celestia Higano, Paul F. Schelhammer, James Faulkner, E. David Crawford, George Wilding, Atif Akdas, Eric J. Small, Bryan Donnelly, Gary MacVicar, Derek Raghavan

From the University of Michigan, Ann Arbor, MI; Southwest Oncology Group Statistical Center; Puget Sound Oncology Consortium, Seattle, WA; Devine-Tidewater Urology, Norfolk, VA; University of Colorado Health Science Center, Denver, CO; University of Wisconsin Hospital and Clinics, Madison, WI; Marmara University Hospital, Istanbul, Turkey; University of California, San Francisco, San Francisco, CA; Prostate Cancer Institute, Calgary, Canada; Northwestern University, Feinberg School of Medicine, Chicago, IL; and the Cleveland Clinic Foundation, Cleveland, OH

Address reprint requests to Southwest Oncology Group (SWOG-9346), Operations Office, 14980 Omicron Drive, San Antonio, TX 78245-3217; e-mail: pubs{at}swog.org

PURPOSE: To establish whether absolute prostate-specific antigen (PSA) value after androgen deprivation (AD) is prognostic in metastatic (D2) prostate cancer (PCa).

PATIENTS AND METHODS: D2 PCa patients with baseline PSA of at least 5 ng/mL received 7 months induction AD. Patients achieving PSA of 4.0 ng/mL or less on months 6 and 7 are randomly assigned to continuous versus intermittent AD on month 8. Eligibility for this analysis required a prestudy PSA with at least two subsequent PSAs and that patients be registered at least 1 year before analysis date. Survival was defined as time to death after 7 months of AD. Associations were evaluated by proportional hazards regression models.

RESULTS: One thousand one hundred thirty four of 1,345 eligible patients achieved a PSA of 4 ng/mL or less. At end of induction, 965 patients maintained PSA of 4 or less and 604 had a PSA of 0.2 ng/mL or less. After controlling for prognostic factors, patients with a PSA of 4 or less to more than 0.2 ng/mL had less than one third the risk of death (ROD) as those with a PSA of more than 4 ng/mL (P < .001). Patients with PSA of 0.2 ng/mL or less had less than one fifth the ROD as patients with a PSA of more than 4 ng/mL (P < .001) and had significantly better survival than those with PSA of more than 0.2 to 4 ng/mL or less (P < .001). Median survival was 13 months for patients with a PSA of more than 4 ng/mL, 44 months for patients with PSA of more than 0.2 to 4 ng/mL or less, and 75 months for patients with PSA of 0.2 ng/mL or less.

CONCLUSION: A PSA of 4 ng/mL or less after 7 months of AD is a strong predictor of survival. This data should be used to tailor future trial design for D2 prostate cancer.

Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, June 2-6, 2006.

Supported in part by the following Public Health Service Cooperative Agreement Grants No. awarded by the National Cancer Institute (National Institutes of Health, Bethesda, MD), Department of Health and Human Services: CA38926, CA32102, CA14028, CA58882, CA42777, CA46441, CA58658, CA46282, CA35192, CA58416, CA46113, CA76132, CA45807, CA20319, CA27057, CA04919, CA12644, CA35431, CA22433, CA35261, CA46368, CA67575, CA58861, CA76447, CA63848, CA37981, CA63844, CA46136, CA45560, CA11083, CA67663, CA16385, CA12213, CA35119, CA35090, CA35178, CA63845, CA86780, CA74647, CA45461, CA95860, CA45377, CA35281, CA35996, CA45808, CA35128, and CA35262.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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