Elevated prostate specific antigen serum levels after intravesical instillation of bacillus Calmette-Guerin

Purpose: We determined whether intravesical bacillus Calmette-Guerin (BCG) instillation is associated with elevated prostate specific antigen (PSA). Materials and Methods: We treated 36 consecutive patients with bladder canc er with a 6-week course of BCG, followed by cystoscopy at 6 weeks. Blood sa mples for PSA determination were obtained before each BCG instillation and at cystoscopy with each patient also serving as a control. PSA elevation wa s defined as 2-fold the baseline level in at least 2 specimens and any PSA level greater than 4 ng./ml. was considered clinically significant. Digital rectal examination was done to identify firm nodules and prostate size. Th e prostate was examined histologically by transrectal ultrasound guided bio psy or after radical cystectomy. Results: We observed elevated PSA in 27 men (75%) during BCG treatment, of whom 15 (41.6%) had a clinically significant elevation. Overall average PSA increased from 1.3 ng./ml. before BCG instillation to 3.8 during treatment (range 0.1 to 21.5, p <0.0001). In those with a clinically significant ele vation average PSA increased from 2.31 ng./ml. at baseline to 6.97 during t reatment (p <0.0001) and returned to 3.86 ng./ml. 3 months after treatment. Palpation demonstrated prostatic findings in 10 patients, including firm n odules in 7, while there was significantly elevated PSA in 5 with firm nodu les and 2 with diffuse prostatic enlargement. Histological examination of t he prostate in 10 patients was diagnostic for granulomatous prostatitis, no nspecific inflammation and benign prostatic hyperplasia in 3, 3 and 4, resp ectively, of whom none had prostate cancer. Conclusions: Intravesical BCG therapy is associated with significantly elev ated PSA in up to 40% of cases. This effect is self-limited and PSA reverts to normal in 3 months. Therefore, we suggest that prostate biopsy be withh eld in such patients and PSA monitored.