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 cancer with a 6-week course of BCG, followed by cystoscopy at 6 weeks. Blood samples for PSA determination were obtained before each BCG instillation and at cystoscopy with each patient also serving as a control. PSA elevation was 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. The prostate was examined histologically by transrectal ultrasound guided biopsy 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 elevation average PSA increased from 2.31 ng./ml. at baseline to 6.97 during treatment (p <0.0001) and returned to 3.86 ng./ml. 3 months after treatment. Palpation demonstrated prostatic findings in 10 patients, including firm nodules in 7, while there was significantly elevated PSA in 5 with firm nodules and 2 with diffuse prostatic enlargement. Histological examination of the prostate in 10 patients was diagnostic for granulomatous prostatitis, nonspecific inflammation and benign prostatic hyperplasia in 3, 3 and 4, respectively, of whom none had prostate cancer. CONCLUSIONS: Intravesical BCG therapy is associated with significantly elevated 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 withheld in such patients and PSA monitored.