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Biochemical Markers for Monitoring Response to Therapy: Evidence for Higher Bone Specificity by a Novel Marker Compared with Routine Markers

¹ Nordic Bioscience Diagnostics A/S, Herlev, Denmark and ² Department of Urology and Paediatric Urology, Medical School, Philipps-University Marburg, Marburg, Germany

Requests for reprints: Diana J. Leeming, Nordic Bioscience A/S, Herlev Hovedgade 207, DK-2730 Herlev, Denmark. Phone: 45-4452-5216; Fax: 45-4454-8888. E-mail: djl{at}nordicbioscience.com

The aim of the present study was to compare a novel marker for high bone turnover with two routine markers for screening in prostate cancer patients. The markers were evaluated in two studies: (a) a cross-sectional study of 170 prostate cancer patients with local disease stratified by ±lymph node metastases (N₀, N₁) compared with controls and (b) a longitudinal study of 40 hormone refractory prostate cancer patients stratified by skeletal involvement and followed during docetaxel (+/–BM) and zoledronate (+BM) treatment. Presence or absence of bone metastases (BM) was assessed by imaging techniques (magnetic resonance imaging or X-ray) and technetium-99m scintigraphy. The serum or urinary levels of alpha C-telopeptide of collagen type I (CTX), prostate-specific antigen (PSA), and total alkaline phosphatase (tALP) were assessed. PSA was elevated in both N₀ and N₁ patients compared with controls, whereas CTX was elevated only in N₁ patients. tALP exhibited no difference in any of the groups. In the treatment study, PSA decreased with treatment in both the –BM and +BM groups compared with baseline values, showing similar effect of docetaxel or docetaxel/zoledronate treatment on this marker. On the contrary, CTX and tALP did not decrease with docetaxel treatment in the –BM group compared with baseline, whereas it decreased significantly with docetaxel/zoledronate treatment in the +BM group, already after 1 month of treatment for CTX. Results suggest that CTX is superior to PSA and tALP for identifying patients having a high risk of metastatic disease and for monitoring skeletal progression in +BM prostate cancer patients during treatment. (Cancer Epidemiol Biomarkers Prev 2008;17(5):1269–76)