Are prostate biopsies mandatory in patients with prostate-specific antigen increase during intravesical immuno- or chemotherapy for superficial bladder cancer?

Prostate. 2008 Aug 1;68(11):1241-7. doi: 10.1002/pros.20790.


Background: Aim of this study was to evaluate if there was a significant association between intravesical immuno- or chemotherapy and the increase of PSA serum level. It could be important to avoid useless prostate biopsies.

Methods: PSA values were determined in 106 male patients who had undergone intravesical immuno- (77 cases) or chemotherapy (29 cases) from 2001 to 2005. Blood samples were obtained before and after the induction course of instillation therapy and at 3, 6, and 12 months during the maintenance course.

Results: 41.6% of patients at the end of the BCG induction course and 45.5% at 3 months from the beginning of the immunotherapy showed a clinically and statistically significant increase of PSA that returned to the baseline levels within 12 months. Prostate biopsies, performed in 10 patients during BCG therapy, showed inflammatory pictures in 9 cases and a prostate cancer in 1 patient with persistently elevated PSA at 12 months. In 1 case a prostate cancer was histologically found following radical cystectomy for disease progression. A statistically but not clinically significant difference of PSA level was registered in patients treated with chemotherapy.

Conclusions: Our results confirm that a statistically and clinically significant PSA increase is registered during immunotherapy but not during chemotherapy. PSA elevation in patients treated with intravesical BCG is self-limited and prostate biopsies are not mandatory in these patients and could be delayed at 12 months, while monitoring PSA. On the other side, prostate biopsies are mandatory in patients with PSA abnormal elevation during chemotherapy.

Publication types

  • Clinical Trial

MeSH terms

  • Aged
  • Antibiotics, Antineoplastic / administration & dosage*
  • BCG Vaccine*
  • Biopsy
  • Drug Monitoring / methods*
  • Epirubicin / administration & dosage
  • Humans
  • Immunotherapy
  • Male
  • Middle Aged
  • Mitomycin / administration & dosage*
  • Prospective Studies
  • Prostate / pathology*
  • Prostate-Specific Antigen / blood*
  • Prostatitis / pathology
  • Unnecessary Procedures
  • Urinary Bladder Neoplasms / drug therapy*
  • Urinary Bladder Neoplasms / immunology


  • Antibiotics, Antineoplastic
  • BCG Vaccine
  • Epirubicin
  • Mitomycin
  • Prostate-Specific Antigen