Preliminary evaluation of the effect of dutasteride on PCA3 in post-DRE urine sediments: a randomized, open-label, parallel-group pilot study.
BACKGROUND
Dutasteride is commonly used in patients that are also at risk for prostate cancer (PCa). Therefore, the influence of dutasteride on PCa markers has to be studied. To date, only the effect of dutasteride on serum prostate-specific antigen (PSA) has been studied. This was the first study to investigate the effect of dutasteride on the new PCa marker PCA3, longitudinally and in a dose dependent manner.


METHODS
From April 25, 2005 to October 31, 2006, 16 subjects with benign prostatic hyperplasia (BPH) and 9 subjects with clinically localized PCa were enrolled at the urological outpatient clinics of one university hospital and one community hospital. Eight subjects with BPH and five with PCa received 0.5 mg dutasteride once daily for 3 months, eight with BPH and four with PCa received 3.5 mg. No subjects were withdrawn because of adverse effects.


RESULTS
In all four groups both 0.5 and 3.5 mg dutasteride had a variable effect on the PCA3 score. In contrast, its other effects were consistent as it rapidly reduced serum DHT by >or=90%, over time increased serum T by 20-30%, over time halved serum PSA and decreased prostate volume by 10-16%.


CONCLUSIONS
In this exploratory/pilot study the effect of dutasteride on the PCA3 score was variable. This should be taken into account while using PCA3 in diagnostics. As this study was exploratory, the influence of androgen-deprivation therapy on the PCA3 score should be analyzed further.
van Gils
Martijn P M Q
MP
Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
Hessels
Daphne
D
Peelen
W Pim
WP
Vergunst
Henk
H
Mulders
Peter F A
PF
Schalken
Jack A
JA
D058891:5-alpha Reductase Inhibitors; D000951:Antigens, Neoplasm / Q000096:biosynthesis / Q000235:genetics / Q000652:urine*; D001378:Azasteroids / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000235:genetics / Q000652:urine*; D013196:Dihydrotestosterone / Q000097:blood; D004305:Dose-Response Relationship, Drug; D000068538:Dutasteride; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D017430:Prostate-Specific Antigen / Q000097:blood; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000473:pathology / Q000652:urine; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000652:urine; D012333:RNA, Messenger / Q000096:biosynthesis / Q000235:genetics; D020133:Reverse Transcriptase Polymerase Chain Reaction; D013739:Testosterone / Q000097:blood
D058891:5-alpha Reductase Inhibitors; D000951:Antigens, Neoplasm; D001378:Azasteroids; D014408:Biomarkers, Tumor; D004791:Enzyme Inhibitors; D012333:RNA, Messenger; C479341:prostate cancer antigen 3, human; D013196:Dihydrotestosterone; D013739:Testosterone; D017430:Prostate-Specific Antigen; D000068538:Dutasteride