Prostate-specific antigen changes as a result of chlormadinone acetate administration to patients with benign prostatic hyperplasia: a retrospective multi-institutional study.
BACKGROUND
Antiandrogens used to treat benign prostatic hyperplasia (BPH) may affect the diagnosis of prostate cancer by decreasing serum prostate-specific antigen (PSA) values. We conducted a retrospective survey of BPH patients treated with chlormadinone acetate (CMA) and analysed the effect of CMA on their PSA values.


METHODS
A chart-based, retrospective, multi-institutional survey of clinically diagnosed patients with BPH who had been treated with CMA (Prostal; 50 mg/day) was conducted. The patients were divided into three groups according to their baseline PSA values: <4 ng/mL, Group I; >or=4 ng/mL and <10 ng/mL, Group II; and >or=10 ng/mL, Group III. The changes in the PSA values from baseline after 16, 26, and 52 weeks of CMA therapy were predicted using a nonlinear regression model analysis.


RESULTS
Data from 192 of the 303 enrolled patients were analysed. The predicted percent changes from baseline among all patients after 16, 26, and 52 weeks of treatment were -49.6%, -49.8%, and -49.9%, respectively. The corresponding values were -42.4%, -43.7% and -43.8% in Group I; -57.4%, -58.4% and -58.5% in Group II; and -50.6%, -50.6% and -50.6% in Group III, respectively.


CONCLUSIONS
The PSA values reached a nadir, approximately -50% of the baseline, after 16 weeks of CMA administration and remained at the same level thereafter. When CMA is used to treat BPH patients, the possibility of abnormal increases in PSA associated with prostate cancer must be considered; if prostate cancer is suspected, prompt testing, including a biopsy, should be performed.
Fujimoto
Kiyohide
K
Department of Urology, Nara Medical University, Kashihara, and Institute for Preventive Medicine, Kurosawa Hospital, Takasaki, Japan. kiyokun@naramed-u.ac.jp
Hirao
Yoshihiko
Y
Masumori
Naoya
N
Arai
Yoichi
Y
Yamanaka
Hidetoshi
H
Kato
Toshihiko
T
Miyazawa
Katsuhito
K
D000368:Aged; D000369:Aged, 80 and over; D002715:Chlormadinone Acetate / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017711:Nonlinear Dynamics; D017430:Prostate-Specific Antigen / Q000097:blood*; D011470:Prostatic Hyperplasia / Q000097:blood* / Q000188:drug therapy*; D012189:Retrospective Studies
D002715:Chlormadinone Acetate; D017430:Prostate-Specific Antigen