Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study.
OBJECTIVE
To evaluate the efficacy and safety of 2 years' treatment of moderate benign prostatic hyperplasia (BPH) with finasteride.


METHODS
Double-blind, parallel-group, placebo-controlled, multicentre, prospective randomized study.


METHODS
Outpatient care in 28 centres across Canada.


METHODS
Men aged 45 to 80, in good health, with moderate BPH and no evidence of prostate cancer. A total of 613 men were entered into the study; 472 completed the 2 years of treatment.


METHODS
After 1 month of receiving a placebo (run-in period), patients were given either finasteride (5 mg/d) or a placebo for 2 years.


METHODS



RESULTS
changes from baseline in BPH symptom scores, maximum urinary flow rates and prostate volume.


RESULTS
onset, course and resolution of all adverse events during the treatment period.


RESULTS
In the efficacy analyses the mean BPH symptom scores decreased 2.1 points (from 15.8 to 13.7) in the finasteride group, as compared with a decrease of 0.7 points (from 16.6 to 15.9) in the placebo group (P < or = 0.01). The maximum urinary flow rate increased by a mean of 1.4 mL/s (from 11.1 to 12.5 mL/s) in the finasteride group, as compared with an increase of 0.3 mL/s (from 10.9 to 11.2 mL/s) in the placebo group (p < or = 0.01). The mean prostate volume decreased by 21% (from a mean volume of 44.1 cm3 at baseline) in the treatment group; it increased by 8.4% (from a mean volume of 45.8 cm3 at baseline) in the placebo group (p < or = 0.01). In the safety analysis, the proportion of patients who experienced any adverse event was similar in the two groups (81.0% in the treatment group and 81.2% in the placebo group). However, the incidence of adverse events related to sexual dysfunction were significantly higher in the finasteride group than in the placebo group (ejaculation disorder 7.7% v. 1.7% and impotence 15.8% v. 6.3%; p < or = 0.01 for both parameters).


CONCLUSIONS
Finasteride is a well-tolerated and effective alternative to watchful waiting in the treatment of moderate BPH.
Queen's University, Kingston, Ont.
J C
JC
Nickel
Y
Y
Fradet
R C
RC
Boake
P J
PJ
Pommerville
J P
JP
Perreault
S K
SK
Afridi
M M
MM
Elhilali
D000368:Aged; D000369:Aged, 80 and over; D002170:Canada; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D018120:Finasteride / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D012449:Safety; D014554:Urination / Q000187:drug effects
D004791:Enzyme Inhibitors; D018120:Finasteride